Blood Banking

Blood for transfusion

Photo by Elise Amendola

ORLANDO, FL—The storage duration of red blood cells (RBCs) doesn’t affect transfusion outcomes in children with lactic acidosis due to severe anemia, according to a new study.

Investigators found no significant differences in lactate levels, 30-day recovery, survival, or adverse events between children who received RBCs stored for 25 to 35 days and children who received RBCs stored for 1 to 10 days.

These results were published in JAMA and presented at the 2015 ASH Annual Meeting as abstract 769.

Christine Cserti-Gazdewich, MD, of University Health Network in Toronto, Canada, provided insights on the data during a press conference at ASH.

A concern of the investigators, according to Dr Cserti-Gazdewich, was that previous studies on blood storage were conducted in “high-income countries in high-technology care settings with blood inventory wealth, and findings may not be generalizable to the other half of the world.”

She pointed out that, in less developed countries, the shortfall in blood availability compared to the need is up to 3-fold.

So the investigators examined whether longer-stored red blood cells actually deliver oxygen in a manner not worse than shorter-stored or fresh blood and examined it at the extremes of storage duration in the context of a very high-dose need.

The team evaluated 290 children (aged 6 months to 60 months) with elevated blood lactate levels due to severe anemia who presented at a university-affiliated national referral hospital in Kampala, Uganda.

The children were randomized to receive RBC units stored for 25 to 35 days (longer-storage group, n=145) or RBCs stored for 1 to 10 days (shorter-storage group, n=145).

All units were leukoreduced prior to storage. All patients received 10 mL/kg of RBCs during hours 0 through 2 and, if indicated per protocol, an additional 10 mL/kg during hours 4 through 6.

In the entire population, the mean presenting hemoglobin level was 3.7 g/dL, and the mean lactate level was 9.3 mmol/L. The median RBC unit storage duration was 8 days (range, 7-9) for the shorter-storage group and 32 days (range, 30-34) for the longer-storage group.

Results

The investigators found that RBC units maintained under standard storage conditions for 25 to 35 days were not inferior to RBC units stored for up to 10 days.

The study’s primary endpoint was the proportion of patients with a lactate level of 3 mmol/L or lower at 8 hours, using a margin of noninferiority equal to an absolute difference of 25%.

The proportion of patients meeting this endpoint was 0.61 in the longer-storage group and 0.58 in the shorter-storage group (P<0.001 for noninferiority).

Average lactate levels were not statistically different between the 2 groups at 0, 2, 4, 6, 8, or 24 hours. And there was no statistical difference in the median time to achieve a blood lactate of 3 mmol/L or lower at 4 hours (hazard ratio=0.99, P=0.92).

Cerebral tissue oxygen saturation rose significantly during transfusion, but there was no significant difference between the 2 storage groups. The median area under the curve of cerebral tissue oxygen saturation during transfusion was 679 (range, 334-1156) for the longer-storage group and 521 (range, 303-835) for the shorter-storage group (P=0.25).

There was no significant difference between the longer-storage group and the shorter-storage group in the persistence of stupor or coma 8 hours after transfusion (12.6% and 19.6%, respectively, P=0.11) or the persistence of respiratory distress at 8 hours (28.7% and 30%, respectively, P=0.79).

The median length of hospital stay was 4 days (range, 2-6) in the longer-storage group and 4 days (range, 3-7) in the shorter-storage group.

There were 8 deaths, 3 in the longer-storage group and 5 in the shorter-storage group, during the 24 hours from the start of transfusion. Four additional patients, 2 in each group, died in the hospital after the initial 24-hour observation period.

The proportion of patients who had returned to good health by 30 days was 86% of the longer-storage group and 93% of the shorter-storage group (P=0.13).

“By every single measure we explored, and we explored many, we found that long-stored blood was not inferior . . . ,” Dr Csert-Gazdewich said. “We truly found no justification to shorten the current storage duration of red cells as judged by the fundamental role to deliver oxygen.”

Blood for transfusion

Photo by Elise Amendola

ORLANDO, FL—The storage duration of red blood cells (RBCs) doesn’t affect transfusion outcomes in children with lactic acidosis due to severe anemia, according to a new study.

Investigators found no significant differences in lactate levels, 30-day recovery, survival, or adverse events between children who received RBCs stored for 25 to 35 days and children who received RBCs stored for 1 to 10 days.

These results were published in JAMA and presented at the 2015 ASH Annual Meeting as abstract 769.

Christine Cserti-Gazdewich, MD, of University Health Network in Toronto, Canada, provided insights on the data during a press conference at ASH.

A concern of the investigators, according to Dr Cserti-Gazdewich, was that previous studies on blood storage were conducted in “high-income countries in high-technology care settings with blood inventory wealth, and findings may not be generalizable to the other half of the world.”

She pointed out that, in less developed countries, the shortfall in blood availability compared to the need is up to 3-fold.

So the investigators examined whether longer-stored red blood cells actually deliver oxygen in a manner not worse than shorter-stored or fresh blood and examined it at the extremes of storage duration in the context of a very high-dose need.

The team evaluated 290 children (aged 6 months to 60 months) with elevated blood lactate levels due to severe anemia who presented at a university-affiliated national referral hospital in Kampala, Uganda.

The children were randomized to receive RBC units stored for 25 to 35 days (longer-storage group, n=145) or RBCs stored for 1 to 10 days (shorter-storage group, n=145).

All units were leukoreduced prior to storage. All patients received 10 mL/kg of RBCs during hours 0 through 2 and, if indicated per protocol, an additional 10 mL/kg during hours 4 through 6.

In the entire population, the mean presenting hemoglobin level was 3.7 g/dL, and the mean lactate level was 9.3 mmol/L. The median RBC unit storage duration was 8 days (range, 7-9) for the shorter-storage group and 32 days (range, 30-34) for the longer-storage group.

Results

The investigators found that RBC units maintained under standard storage conditions for 25 to 35 days were not inferior to RBC units stored for up to 10 days.

The study’s primary endpoint was the proportion of patients with a lactate level of 3 mmol/L or lower at 8 hours, using a margin of noninferiority equal to an absolute difference of 25%.

The proportion of patients meeting this endpoint was 0.61 in the longer-storage group and 0.58 in the shorter-storage group (P<0.001 for noninferiority).

Average lactate levels were not statistically different between the 2 groups at 0, 2, 4, 6, 8, or 24 hours. And there was no statistical difference in the median time to achieve a blood lactate of 3 mmol/L or lower at 4 hours (hazard ratio=0.99, P=0.92).

Cerebral tissue oxygen saturation rose significantly during transfusion, but there was no significant difference between the 2 storage groups. The median area under the curve of cerebral tissue oxygen saturation during transfusion was 679 (range, 334-1156) for the longer-storage group and 521 (range, 303-835) for the shorter-storage group (P=0.25).

There was no significant difference between the longer-storage group and the shorter-storage group in the persistence of stupor or coma 8 hours after transfusion (12.6% and 19.6%, respectively, P=0.11) or the persistence of respiratory distress at 8 hours (28.7% and 30%, respectively, P=0.79).

The median length of hospital stay was 4 days (range, 2-6) in the longer-storage group and 4 days (range, 3-7) in the shorter-storage group.

There were 8 deaths, 3 in the longer-storage group and 5 in the shorter-storage group, during the 24 hours from the start of transfusion. Four additional patients, 2 in each group, died in the hospital after the initial 24-hour observation period.

The proportion of patients who had returned to good health by 30 days was 86% of the longer-storage group and 93% of the shorter-storage group (P=0.13).

“By every single measure we explored, and we explored many, we found that long-stored blood was not inferior . . . ,” Dr Csert-Gazdewich said. “We truly found no justification to shorten the current storage duration of red cells as judged by the fundamental role to deliver oxygen.”

Blood for transfusion

Photo by Elise Amendola

ORLANDO, FL—The storage duration of red blood cells (RBCs) doesn’t affect transfusion outcomes in children with lactic acidosis due to severe anemia, according to a new study.

Investigators found no significant differences in lactate levels, 30-day recovery, survival, or adverse events between children who received RBCs stored for 25 to 35 days and children who received RBCs stored for 1 to 10 days.

These results were published in JAMA and presented at the 2015 ASH Annual Meeting as abstract 769.

Christine Cserti-Gazdewich, MD, of University Health Network in Toronto, Canada, provided insights on the data during a press conference at ASH.

A concern of the investigators, according to Dr Cserti-Gazdewich, was that previous studies on blood storage were conducted in “high-income countries in high-technology care settings with blood inventory wealth, and findings may not be generalizable to the other half of the world.”

She pointed out that, in less developed countries, the shortfall in blood availability compared to the need is up to 3-fold.

So the investigators examined whether longer-stored red blood cells actually deliver oxygen in a manner not worse than shorter-stored or fresh blood and examined it at the extremes of storage duration in the context of a very high-dose need.

The team evaluated 290 children (aged 6 months to 60 months) with elevated blood lactate levels due to severe anemia who presented at a university-affiliated national referral hospital in Kampala, Uganda.

The children were randomized to receive RBC units stored for 25 to 35 days (longer-storage group, n=145) or RBCs stored for 1 to 10 days (shorter-storage group, n=145).

All units were leukoreduced prior to storage. All patients received 10 mL/kg of RBCs during hours 0 through 2 and, if indicated per protocol, an additional 10 mL/kg during hours 4 through 6.

In the entire population, the mean presenting hemoglobin level was 3.7 g/dL, and the mean lactate level was 9.3 mmol/L. The median RBC unit storage duration was 8 days (range, 7-9) for the shorter-storage group and 32 days (range, 30-34) for the longer-storage group.

Results

The investigators found that RBC units maintained under standard storage conditions for 25 to 35 days were not inferior to RBC units stored for up to 10 days.

The study’s primary endpoint was the proportion of patients with a lactate level of 3 mmol/L or lower at 8 hours, using a margin of noninferiority equal to an absolute difference of 25%.

The proportion of patients meeting this endpoint was 0.61 in the longer-storage group and 0.58 in the shorter-storage group (P<0.001 for noninferiority).

Average lactate levels were not statistically different between the 2 groups at 0, 2, 4, 6, 8, or 24 hours. And there was no statistical difference in the median time to achieve a blood lactate of 3 mmol/L or lower at 4 hours (hazard ratio=0.99, P=0.92).

Cerebral tissue oxygen saturation rose significantly during transfusion, but there was no significant difference between the 2 storage groups. The median area under the curve of cerebral tissue oxygen saturation during transfusion was 679 (range, 334-1156) for the longer-storage group and 521 (range, 303-835) for the shorter-storage group (P=0.25).

There was no significant difference between the longer-storage group and the shorter-storage group in the persistence of stupor or coma 8 hours after transfusion (12.6% and 19.6%, respectively, P=0.11) or the persistence of respiratory distress at 8 hours (28.7% and 30%, respectively, P=0.79).

The median length of hospital stay was 4 days (range, 2-6) in the longer-storage group and 4 days (range, 3-7) in the shorter-storage group.

There were 8 deaths, 3 in the longer-storage group and 5 in the shorter-storage group, during the 24 hours from the start of transfusion. Four additional patients, 2 in each group, died in the hospital after the initial 24-hour observation period.

The proportion of patients who had returned to good health by 30 days was 86% of the longer-storage group and 93% of the shorter-storage group (P=0.13).

“By every single measure we explored, and we explored many, we found that long-stored blood was not inferior . . . ,” Dr Csert-Gazdewich said. “We truly found no justification to shorten the current storage duration of red cells as judged by the fundamental role to deliver oxygen.”

Blood for transfusion

Photo courtesy of UAB Hospital

The National Institute for Health and Care Excellence (NICE) has issued its first guideline on blood transfusions.

The agency said that national audits on the use of blood in England have suggested that at least one-fifth of transfusions are unnecessary.

So NICE developed a guideline to provide recommendations on when a transfusion should be used and when alternatives should be considered.

“This guideline will ensure blood products are used safely and efficiently,” said Mark Baker, MD, director of clinical practice at NICE.

“Hundreds of thousands of people receive blood transfusions every year in England and Wales. We must do all we can to ensure that their experience is a safe one. We know that practice is improving, and, with this guideline, we want to drive things even further so we get closer to transfusions being completely risk-free and people are spared from avoidable harm.”

The guideline contains recommendations to help hospitals reduce the need for transfusions wherever possible. This includes encouraging clinicians to prescribe tranexamic acid, which can be given to patients undergoing surgery to stop them losing too much blood.

The guideline also calls for hospitals to consider using a system that electronically identifies patients to make the transfusion process safer and more efficient.

Electronic patient identification systems prompt staff to carry out key steps in the correct order and ensure that transfusions are given to the right patients through scanning of barcodes on patient wristbands and blood component containers.

“Electronic systems make it easy for staff to do the right thing every time and avoid errors,” said Mike Murphy, MD, a consultant hematologist at Oxford University Hospitals and chair of the committee that developed the guideline.

“They can also provide ‘decision support’ for doctors when they are ordering blood and promote the restrictive use of blood. The guideline also, importantly, highlights the benefits of the routine use of tranexamic acid in patients undergoing surgery. Routine implementation of these measures in the [National Health Service] will make best use of a valuable resource, be safer for patients, and save money for hospitals.”

The guideline is available on the NICE website. NICE has also published a guide for members of the public so they know what care they should expect to receive.

Blood for transfusion

Photo courtesy of UAB Hospital

The National Institute for Health and Care Excellence (NICE) has issued its first guideline on blood transfusions.

The agency said that national audits on the use of blood in England have suggested that at least one-fifth of transfusions are unnecessary.

So NICE developed a guideline to provide recommendations on when a transfusion should be used and when alternatives should be considered.

“This guideline will ensure blood products are used safely and efficiently,” said Mark Baker, MD, director of clinical practice at NICE.

“Hundreds of thousands of people receive blood transfusions every year in England and Wales. We must do all we can to ensure that their experience is a safe one. We know that practice is improving, and, with this guideline, we want to drive things even further so we get closer to transfusions being completely risk-free and people are spared from avoidable harm.”

The guideline contains recommendations to help hospitals reduce the need for transfusions wherever possible. This includes encouraging clinicians to prescribe tranexamic acid, which can be given to patients undergoing surgery to stop them losing too much blood.

The guideline also calls for hospitals to consider using a system that electronically identifies patients to make the transfusion process safer and more efficient.

Electronic patient identification systems prompt staff to carry out key steps in the correct order and ensure that transfusions are given to the right patients through scanning of barcodes on patient wristbands and blood component containers.

“Electronic systems make it easy for staff to do the right thing every time and avoid errors,” said Mike Murphy, MD, a consultant hematologist at Oxford University Hospitals and chair of the committee that developed the guideline.

“They can also provide ‘decision support’ for doctors when they are ordering blood and promote the restrictive use of blood. The guideline also, importantly, highlights the benefits of the routine use of tranexamic acid in patients undergoing surgery. Routine implementation of these measures in the [National Health Service] will make best use of a valuable resource, be safer for patients, and save money for hospitals.”

The guideline is available on the NICE website. NICE has also published a guide for members of the public so they know what care they should expect to receive.

Blood for transfusion

Photo courtesy of UAB Hospital

The National Institute for Health and Care Excellence (NICE) has issued its first guideline on blood transfusions.

The agency said that national audits on the use of blood in England have suggested that at least one-fifth of transfusions are unnecessary.

So NICE developed a guideline to provide recommendations on when a transfusion should be used and when alternatives should be considered.

“This guideline will ensure blood products are used safely and efficiently,” said Mark Baker, MD, director of clinical practice at NICE.

“Hundreds of thousands of people receive blood transfusions every year in England and Wales. We must do all we can to ensure that their experience is a safe one. We know that practice is improving, and, with this guideline, we want to drive things even further so we get closer to transfusions being completely risk-free and people are spared from avoidable harm.”

The guideline contains recommendations to help hospitals reduce the need for transfusions wherever possible. This includes encouraging clinicians to prescribe tranexamic acid, which can be given to patients undergoing surgery to stop them losing too much blood.

The guideline also calls for hospitals to consider using a system that electronically identifies patients to make the transfusion process safer and more efficient.

Electronic patient identification systems prompt staff to carry out key steps in the correct order and ensure that transfusions are given to the right patients through scanning of barcodes on patient wristbands and blood component containers.

“Electronic systems make it easy for staff to do the right thing every time and avoid errors,” said Mike Murphy, MD, a consultant hematologist at Oxford University Hospitals and chair of the committee that developed the guideline.

“They can also provide ‘decision support’ for doctors when they are ordering blood and promote the restrictive use of blood. The guideline also, importantly, highlights the benefits of the routine use of tranexamic acid in patients undergoing surgery. Routine implementation of these measures in the [National Health Service] will make best use of a valuable resource, be safer for patients, and save money for hospitals.”

The guideline is available on the NICE website. NICE has also published a guide for members of the public so they know what care they should expect to receive.

Blood drop

Finger-prick blood tests can deliver inaccurate results, according to a study published in the American Journal of Clinical Pathology.

Investigators found that results varied greatly when they performed multiple finger-prick tests on a single subject.

However, averaging the results of multiple droplet tests allowed the investigators to achieve results on par with venous blood tests.

They required 6 to 9 drops of blood to achieve consistent results.

“We began looking at this after we got some surprising results from our controls in an earlier study,” explained lead investigator Rebecca Richards-Kortum, PhD, of Rice University in Houston, Texas.

“Students in my lab are developing novel, low-cost platforms for anemia, platelet, and white blood cell testing in low-resource settings, and one of my students, Meaghan Bond, noticed there was wide variation in some of the benchmark tests that she was performing on hospital-grade blood analyzers.”

The benchmark controls are used to gauge the accuracy of test results from the new technology under study, so the variation among the control data was a sign that something was amiss.

What wasn’t immediately clear was whether the readings resulted from a problem with the current experiments or actual variations in the amount of hemoglobin, platelets, and white blood cells in the different drops of blood.

So Dr Richards-Kortum and Bond designed a simple protocol to test whether there was actual variation and, if so, how much.

They drew 6 successive 20 µL droplets of blood from 11 donors. As an additional test to determine whether minimum droplet size might also affect the results, the pair drew 10 successive 10 µL droplets from 7 additional donors.

All droplets were drawn from the same finger prick, and the investigators followed best practices in obtaining the droplets. The first drop was wiped away to remove contamination from disinfectants, and the finger was not squeezed or “milked,” which can lead to inaccurate results.

For experimental controls, the investigators used venipuncture to draw tubes of blood from an arm vein.

Each 20 µL droplet was analyzed with a hospital-grade blood analyzer for hemoglobin concentration, total white blood cell count, platelet count, and 3-part white blood cell differential. Each 10 µL droplet was tested for hemoglobin concentration with a popular point-of-care blood analyzer.

“A growing number of clinically important tests are performed using finger-prick blood, and this is especially true in low-resource settings,” Bond noted.

“It is important to understand how variations in finger-prick blood collection protocols can affect point-of-care test accuracy as well as how results might vary between different kinds of point-of-care tests that use finger-prick blood from the same patient.”

She and Dr Richards-Kortum found that hemoglobin content, platelet count, and white blood cell count each varied significantly from blood drop to blood drop.

“Some of the differences were surprising,” Bond said. “For example, in some donors, the hemoglobin concentration changed by more than 2 g/dL in the span of 2 successive drops of blood.”

Fortunately, the investigators found that averaging the results of the droplet tests could produce results that were on par with venous blood tests, but tests on 6 to 9 drops of blood were needed to achieve consistent results.

“Finger-prick blood tests can be accurate, and they are an important tool for healthcare providers, particularly in point-of-care and low-resource settings,” Bond said.

“Our results show that people need to take care to administer finger-prick tests in a way that produces accurate results because accuracy in these tests is increasingly important for diagnosing conditions like anemia, infections, and sickle cell anemia, malaria, HIV, and other diseases.”

Blood drop

Finger-prick blood tests can deliver inaccurate results, according to a study published in the American Journal of Clinical Pathology.

Investigators found that results varied greatly when they performed multiple finger-prick tests on a single subject.

However, averaging the results of multiple droplet tests allowed the investigators to achieve results on par with venous blood tests.

They required 6 to 9 drops of blood to achieve consistent results.

“We began looking at this after we got some surprising results from our controls in an earlier study,” explained lead investigator Rebecca Richards-Kortum, PhD, of Rice University in Houston, Texas.

“Students in my lab are developing novel, low-cost platforms for anemia, platelet, and white blood cell testing in low-resource settings, and one of my students, Meaghan Bond, noticed there was wide variation in some of the benchmark tests that she was performing on hospital-grade blood analyzers.”

The benchmark controls are used to gauge the accuracy of test results from the new technology under study, so the variation among the control data was a sign that something was amiss.

What wasn’t immediately clear was whether the readings resulted from a problem with the current experiments or actual variations in the amount of hemoglobin, platelets, and white blood cells in the different drops of blood.

So Dr Richards-Kortum and Bond designed a simple protocol to test whether there was actual variation and, if so, how much.

They drew 6 successive 20 µL droplets of blood from 11 donors. As an additional test to determine whether minimum droplet size might also affect the results, the pair drew 10 successive 10 µL droplets from 7 additional donors.

All droplets were drawn from the same finger prick, and the investigators followed best practices in obtaining the droplets. The first drop was wiped away to remove contamination from disinfectants, and the finger was not squeezed or “milked,” which can lead to inaccurate results.

For experimental controls, the investigators used venipuncture to draw tubes of blood from an arm vein.

Each 20 µL droplet was analyzed with a hospital-grade blood analyzer for hemoglobin concentration, total white blood cell count, platelet count, and 3-part white blood cell differential. Each 10 µL droplet was tested for hemoglobin concentration with a popular point-of-care blood analyzer.

“A growing number of clinically important tests are performed using finger-prick blood, and this is especially true in low-resource settings,” Bond noted.

“It is important to understand how variations in finger-prick blood collection protocols can affect point-of-care test accuracy as well as how results might vary between different kinds of point-of-care tests that use finger-prick blood from the same patient.”

She and Dr Richards-Kortum found that hemoglobin content, platelet count, and white blood cell count each varied significantly from blood drop to blood drop.

“Some of the differences were surprising,” Bond said. “For example, in some donors, the hemoglobin concentration changed by more than 2 g/dL in the span of 2 successive drops of blood.”

Fortunately, the investigators found that averaging the results of the droplet tests could produce results that were on par with venous blood tests, but tests on 6 to 9 drops of blood were needed to achieve consistent results.

“Finger-prick blood tests can be accurate, and they are an important tool for healthcare providers, particularly in point-of-care and low-resource settings,” Bond said.

“Our results show that people need to take care to administer finger-prick tests in a way that produces accurate results because accuracy in these tests is increasingly important for diagnosing conditions like anemia, infections, and sickle cell anemia, malaria, HIV, and other diseases.”

Blood drop

Finger-prick blood tests can deliver inaccurate results, according to a study published in the American Journal of Clinical Pathology.

Investigators found that results varied greatly when they performed multiple finger-prick tests on a single subject.

However, averaging the results of multiple droplet tests allowed the investigators to achieve results on par with venous blood tests.

They required 6 to 9 drops of blood to achieve consistent results.

“We began looking at this after we got some surprising results from our controls in an earlier study,” explained lead investigator Rebecca Richards-Kortum, PhD, of Rice University in Houston, Texas.

“Students in my lab are developing novel, low-cost platforms for anemia, platelet, and white blood cell testing in low-resource settings, and one of my students, Meaghan Bond, noticed there was wide variation in some of the benchmark tests that she was performing on hospital-grade blood analyzers.”

The benchmark controls are used to gauge the accuracy of test results from the new technology under study, so the variation among the control data was a sign that something was amiss.

What wasn’t immediately clear was whether the readings resulted from a problem with the current experiments or actual variations in the amount of hemoglobin, platelets, and white blood cells in the different drops of blood.

So Dr Richards-Kortum and Bond designed a simple protocol to test whether there was actual variation and, if so, how much.

They drew 6 successive 20 µL droplets of blood from 11 donors. As an additional test to determine whether minimum droplet size might also affect the results, the pair drew 10 successive 10 µL droplets from 7 additional donors.

All droplets were drawn from the same finger prick, and the investigators followed best practices in obtaining the droplets. The first drop was wiped away to remove contamination from disinfectants, and the finger was not squeezed or “milked,” which can lead to inaccurate results.

For experimental controls, the investigators used venipuncture to draw tubes of blood from an arm vein.

Each 20 µL droplet was analyzed with a hospital-grade blood analyzer for hemoglobin concentration, total white blood cell count, platelet count, and 3-part white blood cell differential. Each 10 µL droplet was tested for hemoglobin concentration with a popular point-of-care blood analyzer.

“A growing number of clinically important tests are performed using finger-prick blood, and this is especially true in low-resource settings,” Bond noted.

“It is important to understand how variations in finger-prick blood collection protocols can affect point-of-care test accuracy as well as how results might vary between different kinds of point-of-care tests that use finger-prick blood from the same patient.”

She and Dr Richards-Kortum found that hemoglobin content, platelet count, and white blood cell count each varied significantly from blood drop to blood drop.

“Some of the differences were surprising,” Bond said. “For example, in some donors, the hemoglobin concentration changed by more than 2 g/dL in the span of 2 successive drops of blood.”

Fortunately, the investigators found that averaging the results of the droplet tests could produce results that were on par with venous blood tests, but tests on 6 to 9 drops of blood were needed to achieve consistent results.

“Finger-prick blood tests can be accurate, and they are an important tool for healthcare providers, particularly in point-of-care and low-resource settings,” Bond said.

“Our results show that people need to take care to administer finger-prick tests in a way that produces accurate results because accuracy in these tests is increasingly important for diagnosing conditions like anemia, infections, and sickle cell anemia, malaria, HIV, and other diseases.”

Blood donation

A device used to measure hemoglobin can deliver inaccurate results and may have prompted an increase in anemia among blood donors in Ireland, according to the Irish Blood Transfusion Service (IBTS).

The IBTS began using the device—called haemospect—in July 2014 but recently discovered that it cannot detect anemia accurately in all cases.

This may have resulted in anemic individuals donating blood or caused individuals to become anemic by donating.

The IBTS said this issue likely affected female donors more than males, so the organization has decided to temporarily stop taking blood donations from women who have donated in the last 18 months.

The IBTS also said it will perform a full blood count on all male and female donors going forward, until this issue has been resolved.

“Until we have a resolution to the problem that has arisen, we are asking male donors to attend our clinics and give blood,” said IBTS Medical and Scientific Director William Murphy, MD.

“We need male donors to make an extra effort to donate and maintain the blood supply. We will be double-checking all hemoglobin results on these donors.”

Discovering the problem

Haemospect is a noninvasive device that uses white light to detect hemoglobin levels. The device is made by the German company MBR Optical Systems.

IBTS learned of the potential for inaccuracies with haemospect after a blood donor contacted the organization. She had been diagnosed as severely anemic by her doctor but had given blood the week before.

“We have now discovered that the device gives inaccurate results in some individuals with anemia down to, and probably below, 8.4 g/dL,” Dr Murphy said. “As a result of the issue . . . , some women, and probably a much smaller number of men, could have been rendered iron-deficient and anemic from blood donation in the past 18 months.”

Steps to resolution

Since the issue was discovered, more than 30 women with anemia have been identified and contacted. The IBTS said it will contact all donors who are found to be anemic.

“Over the next few weeks, we will introduce new software to reanalyze all the electronic results from all donors who have been tested and accepted for donation since we introduced this device,” Dr Murphy said. “Any discrepant results will be notified to the donors involved.”

Dr Murphy also said donors who think they might be anemic or iron-deficient should visit their doctors for testing, and the IBTS will foot the bill. Concerned donors can contact the IBTS at 1850 731137.

The IBTS plans to replace haemospect with an alternative device as soon as possible. The organization has contacted the Health Products Regularity Authority about the issue with haemospect, which is used in Austria and Germany as well.

“We are determined to have this matter resolved as soon as possible,” Dr Murphy said. “We are confident that this issue . . . has not had any impact on blood received by patients.”

Blood donation

A device used to measure hemoglobin can deliver inaccurate results and may have prompted an increase in anemia among blood donors in Ireland, according to the Irish Blood Transfusion Service (IBTS).

The IBTS began using the device—called haemospect—in July 2014 but recently discovered that it cannot detect anemia accurately in all cases.

This may have resulted in anemic individuals donating blood or caused individuals to become anemic by donating.

The IBTS said this issue likely affected female donors more than males, so the organization has decided to temporarily stop taking blood donations from women who have donated in the last 18 months.

The IBTS also said it will perform a full blood count on all male and female donors going forward, until this issue has been resolved.

“Until we have a resolution to the problem that has arisen, we are asking male donors to attend our clinics and give blood,” said IBTS Medical and Scientific Director William Murphy, MD.

“We need male donors to make an extra effort to donate and maintain the blood supply. We will be double-checking all hemoglobin results on these donors.”

Discovering the problem

Haemospect is a noninvasive device that uses white light to detect hemoglobin levels. The device is made by the German company MBR Optical Systems.

IBTS learned of the potential for inaccuracies with haemospect after a blood donor contacted the organization. She had been diagnosed as severely anemic by her doctor but had given blood the week before.

“We have now discovered that the device gives inaccurate results in some individuals with anemia down to, and probably below, 8.4 g/dL,” Dr Murphy said. “As a result of the issue . . . , some women, and probably a much smaller number of men, could have been rendered iron-deficient and anemic from blood donation in the past 18 months.”

Steps to resolution

Since the issue was discovered, more than 30 women with anemia have been identified and contacted. The IBTS said it will contact all donors who are found to be anemic.

“Over the next few weeks, we will introduce new software to reanalyze all the electronic results from all donors who have been tested and accepted for donation since we introduced this device,” Dr Murphy said. “Any discrepant results will be notified to the donors involved.”

Dr Murphy also said donors who think they might be anemic or iron-deficient should visit their doctors for testing, and the IBTS will foot the bill. Concerned donors can contact the IBTS at 1850 731137.

The IBTS plans to replace haemospect with an alternative device as soon as possible. The organization has contacted the Health Products Regularity Authority about the issue with haemospect, which is used in Austria and Germany as well.

“We are determined to have this matter resolved as soon as possible,” Dr Murphy said. “We are confident that this issue . . . has not had any impact on blood received by patients.”

Blood donation

A device used to measure hemoglobin can deliver inaccurate results and may have prompted an increase in anemia among blood donors in Ireland, according to the Irish Blood Transfusion Service (IBTS).

The IBTS began using the device—called haemospect—in July 2014 but recently discovered that it cannot detect anemia accurately in all cases.

This may have resulted in anemic individuals donating blood or caused individuals to become anemic by donating.

The IBTS said this issue likely affected female donors more than males, so the organization has decided to temporarily stop taking blood donations from women who have donated in the last 18 months.

The IBTS also said it will perform a full blood count on all male and female donors going forward, until this issue has been resolved.

“Until we have a resolution to the problem that has arisen, we are asking male donors to attend our clinics and give blood,” said IBTS Medical and Scientific Director William Murphy, MD.

“We need male donors to make an extra effort to donate and maintain the blood supply. We will be double-checking all hemoglobin results on these donors.”

Discovering the problem

Haemospect is a noninvasive device that uses white light to detect hemoglobin levels. The device is made by the German company MBR Optical Systems.

IBTS learned of the potential for inaccuracies with haemospect after a blood donor contacted the organization. She had been diagnosed as severely anemic by her doctor but had given blood the week before.

“We have now discovered that the device gives inaccurate results in some individuals with anemia down to, and probably below, 8.4 g/dL,” Dr Murphy said. “As a result of the issue . . . , some women, and probably a much smaller number of men, could have been rendered iron-deficient and anemic from blood donation in the past 18 months.”

Steps to resolution

Since the issue was discovered, more than 30 women with anemia have been identified and contacted. The IBTS said it will contact all donors who are found to be anemic.

“Over the next few weeks, we will introduce new software to reanalyze all the electronic results from all donors who have been tested and accepted for donation since we introduced this device,” Dr Murphy said. “Any discrepant results will be notified to the donors involved.”

Dr Murphy also said donors who think they might be anemic or iron-deficient should visit their doctors for testing, and the IBTS will foot the bill. Concerned donors can contact the IBTS at 1850 731137.

The IBTS plans to replace haemospect with an alternative device as soon as possible. The organization has contacted the Health Products Regularity Authority about the issue with haemospect, which is used in Austria and Germany as well.

“We are determined to have this matter resolved as soon as possible,” Dr Murphy said. “We are confident that this issue . . . has not had any impact on blood received by patients.”

Red cells for transfusion

ANAHEIM, CA—The timing of gamma irradiation influences in vitro characteristics of red cell concentrates (RCCs), according to a new study.

The research showed that RCCs sustain more damage the longer they are stored prior to gamma irradiation and the longer they are stored after irradiation.

However, RCCs from female donors appeared to be less susceptible to irradiation injury, and the additive solution used seemed to affect the level of injury as well.

Dirk de Korte, PhD, of Sanquin Blood Bank in Amsterdam, Netherlands, presented these results at the 2015 AABB Annual Meeting (abstract S72-040A).

The study included 7 centers, each of which used its standard RCCs. Five centers used SAGM as additive solution, 1 used AS-3, and 1 used PAGGSM. Two centers used whole blood filtration to prepare leukoreduced RCCs, and 5 centers used buffy coat removal and RCC filtration.

Each center produced 4 pools of 7 RCCs, 2 male and 2 female pools. The units were stored for 43 days, and 1 pool was gamma-irradiated every week.

The researchers also performed weekly sampling to assess in vitro quality parameters. They took an extra sample 24 hours after irradiation and 72 hours after irradiation.

The team found that the age of RCCs at the time of irradiation influenced the rate of increase of hemolysis and the absolute level of hemolysis (P<0.0001).

Hemolysis was higher in units irradiated early and then stored. And the rate of change of hemolysis increased if RCCs were stored for longer before irradiation.

The researchers also found that the age of RCCs at the time of irradiation influenced the rate of increase of potassium and the absolute level of potassium (P<0.0001).

The rate of change of potassium decreased if RCCs were stored longer before irradiation, as potassium was already partly released if the cells were stored longer. Within 7 days of irradiation, potassium levels exceeded those observed in control cells stored for 43 days.

Hemolysis and potassium levels also appeared to be affected by donor sex and the additive solution used.

Hemolysis was lower in RCCs from female donors (P=0.045) and in cells exposed to AS-3 or PAGGSM rather than SAGM (P=0.0597).

Potassium release was lower in cells from female donors (P=0.0032) and in cells exposed to AS-3 rather than PAGGSM or SAGM (P=0.0391).

“This study shows or confirms interesting differences between red cells from males and females, and, of course, we are interested in the underlying mechanism,” Dr de Korte said.

He also said the results of this study will be used to formulate guidance on the maximal pre- and post-irradiation storage time for RCCs with respect to either acceptable hemolysis or potassium release.

Dr de Korte said that, if hemolysis is used as guidance, irradiation should be performed within the first 28 days of storage, and the cells should be used within these 28 days.

If potassium is used as guidance, cells should be used within 7 days of irradiation if the irradiation occurs during the first 10 to 14 days of storage, or the cells should be used immediately after irradiation if irradiation takes place later during storage.

Red cells for transfusion

ANAHEIM, CA—The timing of gamma irradiation influences in vitro characteristics of red cell concentrates (RCCs), according to a new study.

The research showed that RCCs sustain more damage the longer they are stored prior to gamma irradiation and the longer they are stored after irradiation.

However, RCCs from female donors appeared to be less susceptible to irradiation injury, and the additive solution used seemed to affect the level of injury as well.

Dirk de Korte, PhD, of Sanquin Blood Bank in Amsterdam, Netherlands, presented these results at the 2015 AABB Annual Meeting (abstract S72-040A).

The study included 7 centers, each of which used its standard RCCs. Five centers used SAGM as additive solution, 1 used AS-3, and 1 used PAGGSM. Two centers used whole blood filtration to prepare leukoreduced RCCs, and 5 centers used buffy coat removal and RCC filtration.

Each center produced 4 pools of 7 RCCs, 2 male and 2 female pools. The units were stored for 43 days, and 1 pool was gamma-irradiated every week.

The researchers also performed weekly sampling to assess in vitro quality parameters. They took an extra sample 24 hours after irradiation and 72 hours after irradiation.

The team found that the age of RCCs at the time of irradiation influenced the rate of increase of hemolysis and the absolute level of hemolysis (P<0.0001).

Hemolysis was higher in units irradiated early and then stored. And the rate of change of hemolysis increased if RCCs were stored for longer before irradiation.

The researchers also found that the age of RCCs at the time of irradiation influenced the rate of increase of potassium and the absolute level of potassium (P<0.0001).

The rate of change of potassium decreased if RCCs were stored longer before irradiation, as potassium was already partly released if the cells were stored longer. Within 7 days of irradiation, potassium levels exceeded those observed in control cells stored for 43 days.

Hemolysis and potassium levels also appeared to be affected by donor sex and the additive solution used.

Hemolysis was lower in RCCs from female donors (P=0.045) and in cells exposed to AS-3 or PAGGSM rather than SAGM (P=0.0597).

Potassium release was lower in cells from female donors (P=0.0032) and in cells exposed to AS-3 rather than PAGGSM or SAGM (P=0.0391).

“This study shows or confirms interesting differences between red cells from males and females, and, of course, we are interested in the underlying mechanism,” Dr de Korte said.

He also said the results of this study will be used to formulate guidance on the maximal pre- and post-irradiation storage time for RCCs with respect to either acceptable hemolysis or potassium release.

Dr de Korte said that, if hemolysis is used as guidance, irradiation should be performed within the first 28 days of storage, and the cells should be used within these 28 days.

If potassium is used as guidance, cells should be used within 7 days of irradiation if the irradiation occurs during the first 10 to 14 days of storage, or the cells should be used immediately after irradiation if irradiation takes place later during storage.

Red cells for transfusion

ANAHEIM, CA—The timing of gamma irradiation influences in vitro characteristics of red cell concentrates (RCCs), according to a new study.

The research showed that RCCs sustain more damage the longer they are stored prior to gamma irradiation and the longer they are stored after irradiation.

However, RCCs from female donors appeared to be less susceptible to irradiation injury, and the additive solution used seemed to affect the level of injury as well.

Dirk de Korte, PhD, of Sanquin Blood Bank in Amsterdam, Netherlands, presented these results at the 2015 AABB Annual Meeting (abstract S72-040A).

The study included 7 centers, each of which used its standard RCCs. Five centers used SAGM as additive solution, 1 used AS-3, and 1 used PAGGSM. Two centers used whole blood filtration to prepare leukoreduced RCCs, and 5 centers used buffy coat removal and RCC filtration.

Each center produced 4 pools of 7 RCCs, 2 male and 2 female pools. The units were stored for 43 days, and 1 pool was gamma-irradiated every week.

The researchers also performed weekly sampling to assess in vitro quality parameters. They took an extra sample 24 hours after irradiation and 72 hours after irradiation.

The team found that the age of RCCs at the time of irradiation influenced the rate of increase of hemolysis and the absolute level of hemolysis (P<0.0001).

Hemolysis was higher in units irradiated early and then stored. And the rate of change of hemolysis increased if RCCs were stored for longer before irradiation.

The researchers also found that the age of RCCs at the time of irradiation influenced the rate of increase of potassium and the absolute level of potassium (P<0.0001).

The rate of change of potassium decreased if RCCs were stored longer before irradiation, as potassium was already partly released if the cells were stored longer. Within 7 days of irradiation, potassium levels exceeded those observed in control cells stored for 43 days.

Hemolysis and potassium levels also appeared to be affected by donor sex and the additive solution used.

Hemolysis was lower in RCCs from female donors (P=0.045) and in cells exposed to AS-3 or PAGGSM rather than SAGM (P=0.0597).

Potassium release was lower in cells from female donors (P=0.0032) and in cells exposed to AS-3 rather than PAGGSM or SAGM (P=0.0391).

“This study shows or confirms interesting differences between red cells from males and females, and, of course, we are interested in the underlying mechanism,” Dr de Korte said.

He also said the results of this study will be used to formulate guidance on the maximal pre- and post-irradiation storage time for RCCs with respect to either acceptable hemolysis or potassium release.

Dr de Korte said that, if hemolysis is used as guidance, irradiation should be performed within the first 28 days of storage, and the cells should be used within these 28 days.

If potassium is used as guidance, cells should be used within 7 days of irradiation if the irradiation occurs during the first 10 to 14 days of storage, or the cells should be used immediately after irradiation if irradiation takes place later during storage.

Apheresis donation

Photo by ec-jpr

ANAHEIM, CA—A newer, more streamlined apheresis system yields more CD34+ cells from stem cell transplant donors than a previous system, according to a new study.

Researchers used both tools—the COBE Spectra Apheresis System and the Spectra Optia Apheresis System—to collect mononuclear cells (MNCs) from healthy donors and found the collection efficiency and yield was superior with the Spectra Optia.

There were no unanticipated or serious adverse events with either system, and the frequency of treatment-emergent adverse events did not differ according to the system used.

Jose A. Cancelas, MD, PhD, of Hoxworth Blood Center in Cincinnati, Ohio, presented the results of this research at the 2015 AABB Annual Meeting (abstract S21-020A). The study was supported by Terumo BCT, the company that makes both systems.

The COBE Spectra Apheresis System collects MNCs via single-step processing and separation. It has been the gold standard for hematopoietic stem and progenitor cell collection since 1987, Dr Cancelas noted.

The newer Spectra Optia Apheresis System uses optical sensors for tracking the separation process and real-time electronic adjustment of plasma pump velocity (automatic interface management). A single-step, continuous MNC collection (CMNC) protocol, which was recently approved for use with this system in the US, is intended to increase automation and MNC collection reproducibility.

To compare the 2 systems, Dr Cancelas and his colleagues conducted a prospective, randomized, crossover study of 22 healthy donors. They had a mean age of 35 and a mean body mass index of 34.2 kg/m².

The donors underwent 2 MNC collections, first with one apheresis system and then the other. Both times, the donors underwent apheresis on Days 5 and 6 after standard MNC mobilization with granulocyte colony-stimulating factor (G-CSF at 10 mg/kg/day) through Day 5. After the first collection, there was a 2-week washout period.

The study’s primary endpoint was CD34+ cell collection efficiency, which was the percentage of cells collected using the averaged pre/post-collection cell counts as the denominator (CE1). The secondary endpoint was also CD34+ cell collection efficiency, but this was the percentage of cells collected using only the pre-collection cell count as a denominator (CE2).

The researchers also assessed the CD34+ cell yield (CD34+ cells/kg), MNC product contamination/purity, procedure time, product volume, the need for operator involvement, and safety.

Results

All collections processed 1.5 times the total blood volume, and the procedures took nearly 2.5 hours, with no real time difference between the 2 systems.

The average flow rates were 66 mL/minute with the Spectra Optia and 68 mL/minute with COBE Spectra. Product volumes were 143 mL and 139 mL, respectively.

The Optia proved significantly superior to the COBE system with regard to CE1, CE2, and the CD34+ yield.

The mean CD34+ CE1 was 85% with Optia and 66.2% with COBE (P<0.001). The mean CD34+ CE2 was 62% and 48.4%, respectively (P<0.001). And the mean CD34+ yield (cells/kg) was 4.5 and 3.58, respectively (P=0.001).

In addition, granulocyte contamination was lower with the Optia system than the COBE system. The mean granulocyte yield was 7.7 x10⁹ and 10.6 x10⁹ granulocytes per unit, respectively (P=0.022).

However, red blood cell and platelet contaminations were similar between the systems. The mean red blood cell volume was 7.4 mL with Optia and 7.0 mL with COBE (P=0.660). And the mean platelet yield was 4.3 x10¹¹ and 4.6 x10¹¹, respectively (P=0.081).

Overall, there was no significant difference between the Optia and COBE systems in the need for operator adjustments, although there was a trend toward fewer adjustments with the Optia system. It required a median of 5.5 adjustments (range, 0-12), and the COBE system required a median of 6.5 adjustments (range, 1-14).

Dr Cancelas said the frequency of treatment-emergent adverse events did not differ according to the system used. And there were no unanticipated or serious adverse events.

The most frequently reported pre-collection treatment-emergent adverse events were back pain (n=10, 44%), bone pain (n=9, 39%), and fatigue (n=5, 22%).

“These results demonstrate that the Optia CMNC procedure is a safe and efficient means of collecting CD34+ cells in G-CSF mobilized donors,” Dr Cancelas said.

“The Optia collection efficiencies for CD34+ cells were significantly superior to the COBE . . . . And the Optia with automatic interface management system represents a technological advance in our ability to collect CD34+ cells.”

Apheresis donation

Photo by ec-jpr

ANAHEIM, CA—A newer, more streamlined apheresis system yields more CD34+ cells from stem cell transplant donors than a previous system, according to a new study.

Researchers used both tools—the COBE Spectra Apheresis System and the Spectra Optia Apheresis System—to collect mononuclear cells (MNCs) from healthy donors and found the collection efficiency and yield was superior with the Spectra Optia.

There were no unanticipated or serious adverse events with either system, and the frequency of treatment-emergent adverse events did not differ according to the system used.

Jose A. Cancelas, MD, PhD, of Hoxworth Blood Center in Cincinnati, Ohio, presented the results of this research at the 2015 AABB Annual Meeting (abstract S21-020A). The study was supported by Terumo BCT, the company that makes both systems.

The COBE Spectra Apheresis System collects MNCs via single-step processing and separation. It has been the gold standard for hematopoietic stem and progenitor cell collection since 1987, Dr Cancelas noted.

The newer Spectra Optia Apheresis System uses optical sensors for tracking the separation process and real-time electronic adjustment of plasma pump velocity (automatic interface management). A single-step, continuous MNC collection (CMNC) protocol, which was recently approved for use with this system in the US, is intended to increase automation and MNC collection reproducibility.

To compare the 2 systems, Dr Cancelas and his colleagues conducted a prospective, randomized, crossover study of 22 healthy donors. They had a mean age of 35 and a mean body mass index of 34.2 kg/m².

The donors underwent 2 MNC collections, first with one apheresis system and then the other. Both times, the donors underwent apheresis on Days 5 and 6 after standard MNC mobilization with granulocyte colony-stimulating factor (G-CSF at 10 mg/kg/day) through Day 5. After the first collection, there was a 2-week washout period.

The study’s primary endpoint was CD34+ cell collection efficiency, which was the percentage of cells collected using the averaged pre/post-collection cell counts as the denominator (CE1). The secondary endpoint was also CD34+ cell collection efficiency, but this was the percentage of cells collected using only the pre-collection cell count as a denominator (CE2).

The researchers also assessed the CD34+ cell yield (CD34+ cells/kg), MNC product contamination/purity, procedure time, product volume, the need for operator involvement, and safety.

Results

All collections processed 1.5 times the total blood volume, and the procedures took nearly 2.5 hours, with no real time difference between the 2 systems.

The average flow rates were 66 mL/minute with the Spectra Optia and 68 mL/minute with COBE Spectra. Product volumes were 143 mL and 139 mL, respectively.

The Optia proved significantly superior to the COBE system with regard to CE1, CE2, and the CD34+ yield.

The mean CD34+ CE1 was 85% with Optia and 66.2% with COBE (P<0.001). The mean CD34+ CE2 was 62% and 48.4%, respectively (P<0.001). And the mean CD34+ yield (cells/kg) was 4.5 and 3.58, respectively (P=0.001).

In addition, granulocyte contamination was lower with the Optia system than the COBE system. The mean granulocyte yield was 7.7 x10⁹ and 10.6 x10⁹ granulocytes per unit, respectively (P=0.022).

However, red blood cell and platelet contaminations were similar between the systems. The mean red blood cell volume was 7.4 mL with Optia and 7.0 mL with COBE (P=0.660). And the mean platelet yield was 4.3 x10¹¹ and 4.6 x10¹¹, respectively (P=0.081).

Overall, there was no significant difference between the Optia and COBE systems in the need for operator adjustments, although there was a trend toward fewer adjustments with the Optia system. It required a median of 5.5 adjustments (range, 0-12), and the COBE system required a median of 6.5 adjustments (range, 1-14).

Dr Cancelas said the frequency of treatment-emergent adverse events did not differ according to the system used. And there were no unanticipated or serious adverse events.

The most frequently reported pre-collection treatment-emergent adverse events were back pain (n=10, 44%), bone pain (n=9, 39%), and fatigue (n=5, 22%).

“These results demonstrate that the Optia CMNC procedure is a safe and efficient means of collecting CD34+ cells in G-CSF mobilized donors,” Dr Cancelas said.

“The Optia collection efficiencies for CD34+ cells were significantly superior to the COBE . . . . And the Optia with automatic interface management system represents a technological advance in our ability to collect CD34+ cells.”

Apheresis donation

Photo by ec-jpr

ANAHEIM, CA—A newer, more streamlined apheresis system yields more CD34+ cells from stem cell transplant donors than a previous system, according to a new study.

Researchers used both tools—the COBE Spectra Apheresis System and the Spectra Optia Apheresis System—to collect mononuclear cells (MNCs) from healthy donors and found the collection efficiency and yield was superior with the Spectra Optia.

There were no unanticipated or serious adverse events with either system, and the frequency of treatment-emergent adverse events did not differ according to the system used.

Jose A. Cancelas, MD, PhD, of Hoxworth Blood Center in Cincinnati, Ohio, presented the results of this research at the 2015 AABB Annual Meeting (abstract S21-020A). The study was supported by Terumo BCT, the company that makes both systems.

The COBE Spectra Apheresis System collects MNCs via single-step processing and separation. It has been the gold standard for hematopoietic stem and progenitor cell collection since 1987, Dr Cancelas noted.

The newer Spectra Optia Apheresis System uses optical sensors for tracking the separation process and real-time electronic adjustment of plasma pump velocity (automatic interface management). A single-step, continuous MNC collection (CMNC) protocol, which was recently approved for use with this system in the US, is intended to increase automation and MNC collection reproducibility.

To compare the 2 systems, Dr Cancelas and his colleagues conducted a prospective, randomized, crossover study of 22 healthy donors. They had a mean age of 35 and a mean body mass index of 34.2 kg/m².

The donors underwent 2 MNC collections, first with one apheresis system and then the other. Both times, the donors underwent apheresis on Days 5 and 6 after standard MNC mobilization with granulocyte colony-stimulating factor (G-CSF at 10 mg/kg/day) through Day 5. After the first collection, there was a 2-week washout period.

The study’s primary endpoint was CD34+ cell collection efficiency, which was the percentage of cells collected using the averaged pre/post-collection cell counts as the denominator (CE1). The secondary endpoint was also CD34+ cell collection efficiency, but this was the percentage of cells collected using only the pre-collection cell count as a denominator (CE2).

The researchers also assessed the CD34+ cell yield (CD34+ cells/kg), MNC product contamination/purity, procedure time, product volume, the need for operator involvement, and safety.

Results

All collections processed 1.5 times the total blood volume, and the procedures took nearly 2.5 hours, with no real time difference between the 2 systems.

The average flow rates were 66 mL/minute with the Spectra Optia and 68 mL/minute with COBE Spectra. Product volumes were 143 mL and 139 mL, respectively.

The Optia proved significantly superior to the COBE system with regard to CE1, CE2, and the CD34+ yield.

The mean CD34+ CE1 was 85% with Optia and 66.2% with COBE (P<0.001). The mean CD34+ CE2 was 62% and 48.4%, respectively (P<0.001). And the mean CD34+ yield (cells/kg) was 4.5 and 3.58, respectively (P=0.001).

In addition, granulocyte contamination was lower with the Optia system than the COBE system. The mean granulocyte yield was 7.7 x10⁹ and 10.6 x10⁹ granulocytes per unit, respectively (P=0.022).

However, red blood cell and platelet contaminations were similar between the systems. The mean red blood cell volume was 7.4 mL with Optia and 7.0 mL with COBE (P=0.660). And the mean platelet yield was 4.3 x10¹¹ and 4.6 x10¹¹, respectively (P=0.081).

Overall, there was no significant difference between the Optia and COBE systems in the need for operator adjustments, although there was a trend toward fewer adjustments with the Optia system. It required a median of 5.5 adjustments (range, 0-12), and the COBE system required a median of 6.5 adjustments (range, 1-14).

Dr Cancelas said the frequency of treatment-emergent adverse events did not differ according to the system used. And there were no unanticipated or serious adverse events.

The most frequently reported pre-collection treatment-emergent adverse events were back pain (n=10, 44%), bone pain (n=9, 39%), and fatigue (n=5, 22%).

“These results demonstrate that the Optia CMNC procedure is a safe and efficient means of collecting CD34+ cells in G-CSF mobilized donors,” Dr Cancelas said.

“The Optia collection efficiencies for CD34+ cells were significantly superior to the COBE . . . . And the Optia with automatic interface management system represents a technological advance in our ability to collect CD34+ cells.”

Thomas J. Braciale, MD, PhD

Photo courtesy of

Josh Barney/University of

Virginia Health System

An unexpected result of a lab experiment has led researchers to a new way to trigger red blood cell (RBC) production.

They found that engaging a stress receptor on type 1 conventional dendritic cells can induce stress erythropoiesis in mice.

The team believes that, eventually, this method could be used to turn on RBC production in humans when necessary, perhaps to replace a blood transfusion or as a stop-gap measure when a transfusion is delayed.

Thomas J. Braciale, MD, PhD, of the University of Virginia in Charlottesville, and his colleagues conducted this research and reported the results in The Journal of Clinical Investigation.

The team was not investigating RBC production when they made their discovery. They were looking into the role of dendritic cells in the lungs.

Dendritic cells have traditionally been thought to be sensors of infection and inflammation, but a lab test involving the flu virus produced an unexpected effect in mice that ultimately revealed a new aspect to the cells’ function.

The researchers injected mice with the flu virus and an αCD24 monoclonal antibody, which resulted in splenomegaly. The team was baffled at this outcome, so they repeated the experiment, only to get the same results.

“We did it again, and I didn’t believe it, and we did it again, and I didn’t believe it,” Dr Braciale recalled. “I asked whether you needed flu to infect the mice when you injected this antibody. So the postdoc did the experiment, and he just injected the antibody without flu-injecting the mice—giant spleens. After much consultation, after talking with my colleagues in pathology, we decided we were inducing stress erythropoiesis.”

Specifically, the researchers found that engaging CD24 on type 1 conventional dendritic cells upregulates expression of the Kit ligand stem cell factor, which results in Kit-mediated proliferative expansion of early erythroid progenitors and transient reticulocytosis.

“In a very basic way, what we’ve discovered is that the process of regulating stress in the body is mediated—certainly in part, at least—by these dendritic cells,” Dr Braciale explained. “And stress can be a variety of different stresses.”

“It doesn’t have to be infection. It doesn’t have to be inflammation. It can be anemia. It can be hemorrhage. And these cells act to initiate this response that, until this report, there’s been really no evidence that [dendritic] cells ever participate in making red blood cells.”

More work is needed before this approach to RBC production can be tested in humans. However, Dr Braciale is optimistic, based on the findings so far.

“We’re very excited to see where this goes,” he said. “We know that the same things can be done in humans in the following sense. There are mice called humanized mice. These are mice that are engineered so they have a human blood system. And if you inject these mice with this antibody, they’ll make red blood cells.”

Thomas J. Braciale, MD, PhD

Photo courtesy of

Josh Barney/University of

Virginia Health System

An unexpected result of a lab experiment has led researchers to a new way to trigger red blood cell (RBC) production.

They found that engaging a stress receptor on type 1 conventional dendritic cells can induce stress erythropoiesis in mice.

The team believes that, eventually, this method could be used to turn on RBC production in humans when necessary, perhaps to replace a blood transfusion or as a stop-gap measure when a transfusion is delayed.

Thomas J. Braciale, MD, PhD, of the University of Virginia in Charlottesville, and his colleagues conducted this research and reported the results in The Journal of Clinical Investigation.

The team was not investigating RBC production when they made their discovery. They were looking into the role of dendritic cells in the lungs.

Dendritic cells have traditionally been thought to be sensors of infection and inflammation, but a lab test involving the flu virus produced an unexpected effect in mice that ultimately revealed a new aspect to the cells’ function.

The researchers injected mice with the flu virus and an αCD24 monoclonal antibody, which resulted in splenomegaly. The team was baffled at this outcome, so they repeated the experiment, only to get the same results.

“We did it again, and I didn’t believe it, and we did it again, and I didn’t believe it,” Dr Braciale recalled. “I asked whether you needed flu to infect the mice when you injected this antibody. So the postdoc did the experiment, and he just injected the antibody without flu-injecting the mice—giant spleens. After much consultation, after talking with my colleagues in pathology, we decided we were inducing stress erythropoiesis.”

Specifically, the researchers found that engaging CD24 on type 1 conventional dendritic cells upregulates expression of the Kit ligand stem cell factor, which results in Kit-mediated proliferative expansion of early erythroid progenitors and transient reticulocytosis.

“In a very basic way, what we’ve discovered is that the process of regulating stress in the body is mediated—certainly in part, at least—by these dendritic cells,” Dr Braciale explained. “And stress can be a variety of different stresses.”

“It doesn’t have to be infection. It doesn’t have to be inflammation. It can be anemia. It can be hemorrhage. And these cells act to initiate this response that, until this report, there’s been really no evidence that [dendritic] cells ever participate in making red blood cells.”

More work is needed before this approach to RBC production can be tested in humans. However, Dr Braciale is optimistic, based on the findings so far.

“We’re very excited to see where this goes,” he said. “We know that the same things can be done in humans in the following sense. There are mice called humanized mice. These are mice that are engineered so they have a human blood system. And if you inject these mice with this antibody, they’ll make red blood cells.”

Thomas J. Braciale, MD, PhD

Photo courtesy of

Josh Barney/University of

Virginia Health System

An unexpected result of a lab experiment has led researchers to a new way to trigger red blood cell (RBC) production.

They found that engaging a stress receptor on type 1 conventional dendritic cells can induce stress erythropoiesis in mice.

The team believes that, eventually, this method could be used to turn on RBC production in humans when necessary, perhaps to replace a blood transfusion or as a stop-gap measure when a transfusion is delayed.

Thomas J. Braciale, MD, PhD, of the University of Virginia in Charlottesville, and his colleagues conducted this research and reported the results in The Journal of Clinical Investigation.

The team was not investigating RBC production when they made their discovery. They were looking into the role of dendritic cells in the lungs.

Dendritic cells have traditionally been thought to be sensors of infection and inflammation, but a lab test involving the flu virus produced an unexpected effect in mice that ultimately revealed a new aspect to the cells’ function.

The researchers injected mice with the flu virus and an αCD24 monoclonal antibody, which resulted in splenomegaly. The team was baffled at this outcome, so they repeated the experiment, only to get the same results.

“We did it again, and I didn’t believe it, and we did it again, and I didn’t believe it,” Dr Braciale recalled. “I asked whether you needed flu to infect the mice when you injected this antibody. So the postdoc did the experiment, and he just injected the antibody without flu-injecting the mice—giant spleens. After much consultation, after talking with my colleagues in pathology, we decided we were inducing stress erythropoiesis.”

Specifically, the researchers found that engaging CD24 on type 1 conventional dendritic cells upregulates expression of the Kit ligand stem cell factor, which results in Kit-mediated proliferative expansion of early erythroid progenitors and transient reticulocytosis.

“In a very basic way, what we’ve discovered is that the process of regulating stress in the body is mediated—certainly in part, at least—by these dendritic cells,” Dr Braciale explained. “And stress can be a variety of different stresses.”

“It doesn’t have to be infection. It doesn’t have to be inflammation. It can be anemia. It can be hemorrhage. And these cells act to initiate this response that, until this report, there’s been really no evidence that [dendritic] cells ever participate in making red blood cells.”

More work is needed before this approach to RBC production can be tested in humans. However, Dr Braciale is optimistic, based on the findings so far.

“We’re very excited to see where this goes,” he said. “We know that the same things can be done in humans in the following sense. There are mice called humanized mice. These are mice that are engineered so they have a human blood system. And if you inject these mice with this antibody, they’ll make red blood cells.”

Blood donation

Photo by Михаило Јовановић

France is planning to lift its lifetime ban on blood donations from men who have sex with men (MSM), and the change is set to take effect next year.

French officials say that, beginning in Spring 2016, an MSM will be able to donate whole blood in France if he has not had sex with another man in the last 12

months.

An MSM will be allowed to donate plasma if he has been abstinent or had only 1 sexual partner in the last 4 months.

Experts will analyze the impact of this policy change for about a year. If there has been no increase in health risks, the policy may be relaxed further, and MSM donors may be treated the same as non-MSM donors.

Non-MSM individuals in France are deferred from donating blood if they have had more than 1 sexual partner in the last 4 months.

Studies recently conducted in Canada and the UK have suggested that lifting restrictions on MSM blood donors does not

increase the risk of sexually transmitted infections affecting the blood

supply.

France’s lifetime ban on MSM blood donation was enacted in 1983 in an attempt to counter the spread of HIV/AIDS.

Hundreds of people died in France in the 1980s after HIV-tainted blood was distributed by the French National Blood Transfusion Center. HIV-positive blood donations were exported as well, which led to hundreds of additional deaths in other countries.

Bans lifting worldwide

In lifting its lifetime ban on MSM blood donors, France is following the lead of other countries within and outside of Europe.

England, Scotland, Wales, Sweden, and the Netherlands have all lifted their bans on MSM blood donors and changed to a 12-month deferral period. Australia, Japan, and New Zealand also have 12-month deferral periods for MSM blood donors.

South Africa has a 6-month deferral period for MSMs, while Italy and Spain have no policy specific to MSM blood donors. All donors are screened for high-risk sexual practices, and deferrals are made accordingly.

The US and Canada are currently considering adopting a 12-month deferral policy for MSM blood donors. The lifetime ban is still in place in the US, but Canada has a 5-year deferral period for MSMs.

Blood donation

Photo by Михаило Јовановић

France is planning to lift its lifetime ban on blood donations from men who have sex with men (MSM), and the change is set to take effect next year.

French officials say that, beginning in Spring 2016, an MSM will be able to donate whole blood in France if he has not had sex with another man in the last 12

months.

An MSM will be allowed to donate plasma if he has been abstinent or had only 1 sexual partner in the last 4 months.

Experts will analyze the impact of this policy change for about a year. If there has been no increase in health risks, the policy may be relaxed further, and MSM donors may be treated the same as non-MSM donors.

Non-MSM individuals in France are deferred from donating blood if they have had more than 1 sexual partner in the last 4 months.

Studies recently conducted in Canada and the UK have suggested that lifting restrictions on MSM blood donors does not

increase the risk of sexually transmitted infections affecting the blood

supply.

France’s lifetime ban on MSM blood donation was enacted in 1983 in an attempt to counter the spread of HIV/AIDS.

Hundreds of people died in France in the 1980s after HIV-tainted blood was distributed by the French National Blood Transfusion Center. HIV-positive blood donations were exported as well, which led to hundreds of additional deaths in other countries.

Bans lifting worldwide

In lifting its lifetime ban on MSM blood donors, France is following the lead of other countries within and outside of Europe.

England, Scotland, Wales, Sweden, and the Netherlands have all lifted their bans on MSM blood donors and changed to a 12-month deferral period. Australia, Japan, and New Zealand also have 12-month deferral periods for MSM blood donors.

South Africa has a 6-month deferral period for MSMs, while Italy and Spain have no policy specific to MSM blood donors. All donors are screened for high-risk sexual practices, and deferrals are made accordingly.

The US and Canada are currently considering adopting a 12-month deferral policy for MSM blood donors. The lifetime ban is still in place in the US, but Canada has a 5-year deferral period for MSMs.

Blood donation

Photo by Михаило Јовановић

France is planning to lift its lifetime ban on blood donations from men who have sex with men (MSM), and the change is set to take effect next year.

French officials say that, beginning in Spring 2016, an MSM will be able to donate whole blood in France if he has not had sex with another man in the last 12

months.

An MSM will be allowed to donate plasma if he has been abstinent or had only 1 sexual partner in the last 4 months.

Experts will analyze the impact of this policy change for about a year. If there has been no increase in health risks, the policy may be relaxed further, and MSM donors may be treated the same as non-MSM donors.

Non-MSM individuals in France are deferred from donating blood if they have had more than 1 sexual partner in the last 4 months.

Studies recently conducted in Canada and the UK have suggested that lifting restrictions on MSM blood donors does not

increase the risk of sexually transmitted infections affecting the blood

supply.

France’s lifetime ban on MSM blood donation was enacted in 1983 in an attempt to counter the spread of HIV/AIDS.

Hundreds of people died in France in the 1980s after HIV-tainted blood was distributed by the French National Blood Transfusion Center. HIV-positive blood donations were exported as well, which led to hundreds of additional deaths in other countries.

Bans lifting worldwide

In lifting its lifetime ban on MSM blood donors, France is following the lead of other countries within and outside of Europe.

England, Scotland, Wales, Sweden, and the Netherlands have all lifted their bans on MSM blood donors and changed to a 12-month deferral period. Australia, Japan, and New Zealand also have 12-month deferral periods for MSM blood donors.

South Africa has a 6-month deferral period for MSMs, while Italy and Spain have no policy specific to MSM blood donors. All donors are screened for high-risk sexual practices, and deferrals are made accordingly.

The US and Canada are currently considering adopting a 12-month deferral policy for MSM blood donors. The lifetime ban is still in place in the US, but Canada has a 5-year deferral period for MSMs.

Blood donation

Photo by Marja Helander

ANAHEIM—A survey of UK blood donors suggests that as many as 30% of donors who are men who have sex with men (MSM) may not be compliant with the MSM blood donor policy.

The UK’s policy requires that MSMs do not donate blood if they have engaged in sexual activity with another male in the last 12 months.

But the survey indicates that as many as 3 in 10 MSMs are disregarding this policy.

The research also suggests that MSMs who do not comply with the policy engage in riskier sexual behavior than non-MSM male blood donors.

However, the researchers found no increase in the number of sexually transmitted infections present in the blood supply since the donation policy for MSMs changed from a lifetime ban to a 12-month deferral period.

The infections evaluated include human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), and syphilis.

The researchers also emphasized that the prevalence of HIV-positive blood donations in the UK remains low.

Katie Davidson, of Public Health England in London, presented these findings at the 2015 AABB Annual Meeting (abstract S36-030E*).

She noted that, in 2011, the blood services of England, Wales, and Scotland changed the blood donor policy for MSMs from a lifetime ban to a 12-month deferral since last male-to-male sex.

Before this policy change took effect, the blood services estimated that the change would mean 2679 MSMs would be newly eligible to donate blood (0.7% of male donors), and 8 of these donors would have HIV. So there would be a 0.5% increase in HIV risk.

“But what was clear was that these predictions in terms of HIV risk would be very dependent upon compliance,” Davidson said. “And what we mean by compliance is that a donor understands the rule, applies it correctly, and discloses any relevant information when they’re asked.”

To investigate donor behavior and compliance, Davidson and her colleagues conducted a large-scale, anonymous, web-based survey of blood donors.

Each month for 1 year (2013), all eligible new blood donors and at least an equal number of repeat blood donors in the UK were invited, via email, to complete an online questionnaire asking about their sexual history and compliance with the 12-month deferral policy for MSM (if applicable).

The researchers also looked at UK surveillance data on infections (HIV, HBV, HCV, and syphilis) in new and repeat blood donors over 6 years, comparing the incidence of infections before and after the policy change took effect (3 years pre- and post-change).

Donation and compliance

Among 65,439 survey respondents, 22,776 (35%) were male, and 242 (1%) were MSMs. Among the MSMs, 73 reported male-to-male sex within the last 12 months (non-compliance), and 181 said it had been more than 12 months since their last male-to-male sexual encounter.

The researchers adjusted these proportions for differences among the respondents and the donor population and extrapolated the data to the whole UK donor population.

The team estimated that, among 488,523 UK donors, there would be 5471 MSMs. Of the MSM donors, 3713 would be eligible under the new policy, and 1759 would be non-compliant.

So MSM compliance with the 12-month deferral policy would be 99.7% among all male donors but 70.4% of the MSM population.

“So 3 in every 10 MSMs donating blood in the UK shouldn’t be, [according to the estimates],” Davidson said.

The survey asked non-compliant MSM donors to provide their reasons for non-compliance, and many gave more than 1 reason.

“The reasons seemed to be associated, mostly, with self-assessment of their own risk [of transmitting infection] to be low,” Davidson said. “So that was based on the fact that they were in a monogamous relationship, they used condoms, practiced safe sex, or had regular [sexual health] screenings.”

However, there were some donors who regarded the policy as unimportant or said they didn’t agree with it. And there were some donors who didn’t declare their sexual behavior because they knew they wouldn’t be allowed to donate if they did.

Sexual behavior

Among all male respondents who reported having sex within the last 12 months, MSMs were more likely than men who had only female sexual partners to report having sex with more than 1 partner. Fifty percent of MSMs had more than 1 sexual partner in the last 12 months, as did 9.1% of male donors with only female sexual partners.

Ten percent of MSMs reported paying for sex, as did 0.3% of non-MSMs. None of the MSMs reported having a partner who was HIV-positive, and less than 0.1% of non-MSMs said they had an HIV-positive partner.

Eleven percent of MSMs said they had a history of sexually transmitted infection, as did less than 0.1% of non-MSMs.

“So among the responders, there was very low numbers who reported a high-risk partner in the last 12 months,” Davidson noted. “But there was some suggestion, among these low numbers, that this was more common in the MSMs than the non-MSMs.”

She also acknowledged that some donors were unsure about whether they had a high-risk partner in the last 12 months.

Infections

The UK surveillance data on infections encompassed HIV, HBV, HCV, and syphilis.

In all, 3,667,408 blood donations from males were tested for infection in the 3 years prior to the MSM donor policy change, and 3,066,076 donations were tested in the 3 years after the change was implemented.

There were 428 donors who reported having an infection risk before the change and 268 who did so after. There were 577 donors who actually had an infection before the change and 434 who did after. And there were 32 infected MSM donors before the change and 34 after.

“So the number of male donors fell post-change by approximately 20%, [and] the total number of infected donors . . . fell by almost 30%,” Davidson noted.

“However, the number of MSM infected donors marginally increased, [and] the proportion of male infected donors who were MSMs, among all of those who reported a risk, increased from 7% [32/428] to 13% [34/268]. So there seems to be some impact [on infection] from MSMs, but the numbers are very small, and these differences are not significant.”

Predictions and HIV infection

Finally, the researchers compared their predictions from before the MSM blood donor policy change to the actual data after the change. This comparison assumed that the absolute number of compliant MSMs did not change after the policy changed.

In 2007, the group predicted there would be about 2 million blood donations, including 2679 from MSMs. In reality, in 2014, there were 1.9 million blood donations, including 3126 from MSMs.

The researchers predicted the number of HIV-positive donations would be 30, including 8 from MSMs. In reality, in 2014, there were 13 HIV-positive donations, including 1 from an MSM.

So the predicted HIV prevalence per 100,000 donations was 1.4, and the actual HIV prevalence was 0.7. The predicted HIV incidence per 100,000 person-years was 0.9, and the actual HIV incidence was 0.7.

The predicted HIV risk was 0.022 per 100,000, and the actual HIV risk was 0.016 per 100,000.

“So the estimated risk of HIV post-change remains very low,” Davidson noted, adding that she and her colleagues will continue to monitor the impact of the policy change.

*Data in the abstract differ from data presented at the meeting.

Blood donation

Photo by Marja Helander

ANAHEIM—A survey of UK blood donors suggests that as many as 30% of donors who are men who have sex with men (MSM) may not be compliant with the MSM blood donor policy.

The UK’s policy requires that MSMs do not donate blood if they have engaged in sexual activity with another male in the last 12 months.

But the survey indicates that as many as 3 in 10 MSMs are disregarding this policy.

The research also suggests that MSMs who do not comply with the policy engage in riskier sexual behavior than non-MSM male blood donors.

However, the researchers found no increase in the number of sexually transmitted infections present in the blood supply since the donation policy for MSMs changed from a lifetime ban to a 12-month deferral period.

The infections evaluated include human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), and syphilis.

The researchers also emphasized that the prevalence of HIV-positive blood donations in the UK remains low.

Katie Davidson, of Public Health England in London, presented these findings at the 2015 AABB Annual Meeting (abstract S36-030E*).

She noted that, in 2011, the blood services of England, Wales, and Scotland changed the blood donor policy for MSMs from a lifetime ban to a 12-month deferral since last male-to-male sex.

Before this policy change took effect, the blood services estimated that the change would mean 2679 MSMs would be newly eligible to donate blood (0.7% of male donors), and 8 of these donors would have HIV. So there would be a 0.5% increase in HIV risk.

“But what was clear was that these predictions in terms of HIV risk would be very dependent upon compliance,” Davidson said. “And what we mean by compliance is that a donor understands the rule, applies it correctly, and discloses any relevant information when they’re asked.”

To investigate donor behavior and compliance, Davidson and her colleagues conducted a large-scale, anonymous, web-based survey of blood donors.

Each month for 1 year (2013), all eligible new blood donors and at least an equal number of repeat blood donors in the UK were invited, via email, to complete an online questionnaire asking about their sexual history and compliance with the 12-month deferral policy for MSM (if applicable).

The researchers also looked at UK surveillance data on infections (HIV, HBV, HCV, and syphilis) in new and repeat blood donors over 6 years, comparing the incidence of infections before and after the policy change took effect (3 years pre- and post-change).

Donation and compliance

Among 65,439 survey respondents, 22,776 (35%) were male, and 242 (1%) were MSMs. Among the MSMs, 73 reported male-to-male sex within the last 12 months (non-compliance), and 181 said it had been more than 12 months since their last male-to-male sexual encounter.

The researchers adjusted these proportions for differences among the respondents and the donor population and extrapolated the data to the whole UK donor population.

The team estimated that, among 488,523 UK donors, there would be 5471 MSMs. Of the MSM donors, 3713 would be eligible under the new policy, and 1759 would be non-compliant.

So MSM compliance with the 12-month deferral policy would be 99.7% among all male donors but 70.4% of the MSM population.

“So 3 in every 10 MSMs donating blood in the UK shouldn’t be, [according to the estimates],” Davidson said.

The survey asked non-compliant MSM donors to provide their reasons for non-compliance, and many gave more than 1 reason.

“The reasons seemed to be associated, mostly, with self-assessment of their own risk [of transmitting infection] to be low,” Davidson said. “So that was based on the fact that they were in a monogamous relationship, they used condoms, practiced safe sex, or had regular [sexual health] screenings.”

However, there were some donors who regarded the policy as unimportant or said they didn’t agree with it. And there were some donors who didn’t declare their sexual behavior because they knew they wouldn’t be allowed to donate if they did.

Sexual behavior

Among all male respondents who reported having sex within the last 12 months, MSMs were more likely than men who had only female sexual partners to report having sex with more than 1 partner. Fifty percent of MSMs had more than 1 sexual partner in the last 12 months, as did 9.1% of male donors with only female sexual partners.

Ten percent of MSMs reported paying for sex, as did 0.3% of non-MSMs. None of the MSMs reported having a partner who was HIV-positive, and less than 0.1% of non-MSMs said they had an HIV-positive partner.

Eleven percent of MSMs said they had a history of sexually transmitted infection, as did less than 0.1% of non-MSMs.

“So among the responders, there was very low numbers who reported a high-risk partner in the last 12 months,” Davidson noted. “But there was some suggestion, among these low numbers, that this was more common in the MSMs than the non-MSMs.”

She also acknowledged that some donors were unsure about whether they had a high-risk partner in the last 12 months.

Infections

The UK surveillance data on infections encompassed HIV, HBV, HCV, and syphilis.

In all, 3,667,408 blood donations from males were tested for infection in the 3 years prior to the MSM donor policy change, and 3,066,076 donations were tested in the 3 years after the change was implemented.

There were 428 donors who reported having an infection risk before the change and 268 who did so after. There were 577 donors who actually had an infection before the change and 434 who did after. And there were 32 infected MSM donors before the change and 34 after.

“So the number of male donors fell post-change by approximately 20%, [and] the total number of infected donors . . . fell by almost 30%,” Davidson noted.

“However, the number of MSM infected donors marginally increased, [and] the proportion of male infected donors who were MSMs, among all of those who reported a risk, increased from 7% [32/428] to 13% [34/268]. So there seems to be some impact [on infection] from MSMs, but the numbers are very small, and these differences are not significant.”

Predictions and HIV infection

Finally, the researchers compared their predictions from before the MSM blood donor policy change to the actual data after the change. This comparison assumed that the absolute number of compliant MSMs did not change after the policy changed.

In 2007, the group predicted there would be about 2 million blood donations, including 2679 from MSMs. In reality, in 2014, there were 1.9 million blood donations, including 3126 from MSMs.

The researchers predicted the number of HIV-positive donations would be 30, including 8 from MSMs. In reality, in 2014, there were 13 HIV-positive donations, including 1 from an MSM.

So the predicted HIV prevalence per 100,000 donations was 1.4, and the actual HIV prevalence was 0.7. The predicted HIV incidence per 100,000 person-years was 0.9, and the actual HIV incidence was 0.7.

The predicted HIV risk was 0.022 per 100,000, and the actual HIV risk was 0.016 per 100,000.

“So the estimated risk of HIV post-change remains very low,” Davidson noted, adding that she and her colleagues will continue to monitor the impact of the policy change.

*Data in the abstract differ from data presented at the meeting.

Blood donation

Photo by Marja Helander

ANAHEIM—A survey of UK blood donors suggests that as many as 30% of donors who are men who have sex with men (MSM) may not be compliant with the MSM blood donor policy.

The UK’s policy requires that MSMs do not donate blood if they have engaged in sexual activity with another male in the last 12 months.

But the survey indicates that as many as 3 in 10 MSMs are disregarding this policy.

The research also suggests that MSMs who do not comply with the policy engage in riskier sexual behavior than non-MSM male blood donors.

However, the researchers found no increase in the number of sexually transmitted infections present in the blood supply since the donation policy for MSMs changed from a lifetime ban to a 12-month deferral period.

The infections evaluated include human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), and syphilis.

The researchers also emphasized that the prevalence of HIV-positive blood donations in the UK remains low.

Katie Davidson, of Public Health England in London, presented these findings at the 2015 AABB Annual Meeting (abstract S36-030E*).

She noted that, in 2011, the blood services of England, Wales, and Scotland changed the blood donor policy for MSMs from a lifetime ban to a 12-month deferral since last male-to-male sex.

Before this policy change took effect, the blood services estimated that the change would mean 2679 MSMs would be newly eligible to donate blood (0.7% of male donors), and 8 of these donors would have HIV. So there would be a 0.5% increase in HIV risk.

“But what was clear was that these predictions in terms of HIV risk would be very dependent upon compliance,” Davidson said. “And what we mean by compliance is that a donor understands the rule, applies it correctly, and discloses any relevant information when they’re asked.”

To investigate donor behavior and compliance, Davidson and her colleagues conducted a large-scale, anonymous, web-based survey of blood donors.

Each month for 1 year (2013), all eligible new blood donors and at least an equal number of repeat blood donors in the UK were invited, via email, to complete an online questionnaire asking about their sexual history and compliance with the 12-month deferral policy for MSM (if applicable).

The researchers also looked at UK surveillance data on infections (HIV, HBV, HCV, and syphilis) in new and repeat blood donors over 6 years, comparing the incidence of infections before and after the policy change took effect (3 years pre- and post-change).

Donation and compliance

Among 65,439 survey respondents, 22,776 (35%) were male, and 242 (1%) were MSMs. Among the MSMs, 73 reported male-to-male sex within the last 12 months (non-compliance), and 181 said it had been more than 12 months since their last male-to-male sexual encounter.

The researchers adjusted these proportions for differences among the respondents and the donor population and extrapolated the data to the whole UK donor population.

The team estimated that, among 488,523 UK donors, there would be 5471 MSMs. Of the MSM donors, 3713 would be eligible under the new policy, and 1759 would be non-compliant.

So MSM compliance with the 12-month deferral policy would be 99.7% among all male donors but 70.4% of the MSM population.

“So 3 in every 10 MSMs donating blood in the UK shouldn’t be, [according to the estimates],” Davidson said.

The survey asked non-compliant MSM donors to provide their reasons for non-compliance, and many gave more than 1 reason.

“The reasons seemed to be associated, mostly, with self-assessment of their own risk [of transmitting infection] to be low,” Davidson said. “So that was based on the fact that they were in a monogamous relationship, they used condoms, practiced safe sex, or had regular [sexual health] screenings.”

However, there were some donors who regarded the policy as unimportant or said they didn’t agree with it. And there were some donors who didn’t declare their sexual behavior because they knew they wouldn’t be allowed to donate if they did.

Sexual behavior

Among all male respondents who reported having sex within the last 12 months, MSMs were more likely than men who had only female sexual partners to report having sex with more than 1 partner. Fifty percent of MSMs had more than 1 sexual partner in the last 12 months, as did 9.1% of male donors with only female sexual partners.

Ten percent of MSMs reported paying for sex, as did 0.3% of non-MSMs. None of the MSMs reported having a partner who was HIV-positive, and less than 0.1% of non-MSMs said they had an HIV-positive partner.

Eleven percent of MSMs said they had a history of sexually transmitted infection, as did less than 0.1% of non-MSMs.

“So among the responders, there was very low numbers who reported a high-risk partner in the last 12 months,” Davidson noted. “But there was some suggestion, among these low numbers, that this was more common in the MSMs than the non-MSMs.”

She also acknowledged that some donors were unsure about whether they had a high-risk partner in the last 12 months.

Infections

The UK surveillance data on infections encompassed HIV, HBV, HCV, and syphilis.

In all, 3,667,408 blood donations from males were tested for infection in the 3 years prior to the MSM donor policy change, and 3,066,076 donations were tested in the 3 years after the change was implemented.

There were 428 donors who reported having an infection risk before the change and 268 who did so after. There were 577 donors who actually had an infection before the change and 434 who did after. And there were 32 infected MSM donors before the change and 34 after.

“So the number of male donors fell post-change by approximately 20%, [and] the total number of infected donors . . . fell by almost 30%,” Davidson noted.

“However, the number of MSM infected donors marginally increased, [and] the proportion of male infected donors who were MSMs, among all of those who reported a risk, increased from 7% [32/428] to 13% [34/268]. So there seems to be some impact [on infection] from MSMs, but the numbers are very small, and these differences are not significant.”

Predictions and HIV infection

Finally, the researchers compared their predictions from before the MSM blood donor policy change to the actual data after the change. This comparison assumed that the absolute number of compliant MSMs did not change after the policy changed.

In 2007, the group predicted there would be about 2 million blood donations, including 2679 from MSMs. In reality, in 2014, there were 1.9 million blood donations, including 3126 from MSMs.

The researchers predicted the number of HIV-positive donations would be 30, including 8 from MSMs. In reality, in 2014, there were 13 HIV-positive donations, including 1 from an MSM.

So the predicted HIV prevalence per 100,000 donations was 1.4, and the actual HIV prevalence was 0.7. The predicted HIV incidence per 100,000 person-years was 0.9, and the actual HIV incidence was 0.7.

The predicted HIV risk was 0.022 per 100,000, and the actual HIV risk was 0.016 per 100,000.

“So the estimated risk of HIV post-change remains very low,” Davidson noted, adding that she and her colleagues will continue to monitor the impact of the policy change.

*Data in the abstract differ from data presented at the meeting.

Blood donation in progress

ANAHEIM, CA—Data from the STRIDE study have revealed interventions that can mitigate iron deficiency in repeat blood donors.

The study showed that providing repeat blood donors with iron supplements significantly improved their iron status.

But informing donors about their ferritin levels and recommending they take iron pills also significantly improved their iron status.

Meanwhile, patients in control groups became more iron-deficient over the study period.

The study also revealed no difference in ferritin or hemoglobin levels between patients who took 19 mg of iron and those who took 38 mg.

Alan E. Mast, MD, PhD, of the Blood Center of Wisconsin in Milwaukee, presented these results at the 2015 AABB Annual Meeting (abstract S34-030E).

Dr Mast said blood donation removes a lot of iron, and iron is used to make hemoglobin in new red blood cells. But the measurement of hemoglobin does not accurately reflect iron stores.

“That’s really important,” he said. “The only test we do to qualify a blood donor doesn’t tell us if they have iron deficiency or not. And because of that, many regular blood donors become iron-deficient and continue to donate blood.”

Dr Mast said the strategies that appear to mitigate iron deficiency in regular blood donors are oral iron supplements and delaying the donation interval for more than 6 months.

“[However,] the effectiveness of providing iron pills versus providing the donor with information about their iron status has not been previously examined,” he noted.

This was the goal of the STRIDE (Strategies to Reduce Iron Deficiency) study.

Study design

This blinded, randomized, placebo-controlled study enrolled 692 frequent blood donors from 3 blood centers. They were assigned to 1 of 5 arms for 2 years of follow-up.

In 3 arms, donors received pills for 60 days after each donation. They received 38 mg or 19 mg of elemental iron, or they received a placebo.

Donors in the remaining 2 arms received letters after each donation—either a letter informing them of their iron status or a “control” letter thanking them for donating blood and urging them to donate again.

Every iron status letter reported the donor’s ferritin level. If the level was >26 mg/L, the letter simply urged donors to donate again. If the ferritin level was ≤26 mg/L, the letter recommended taking a self-purchased iron supplement (17 mg to 38 mg) and/or delaying donation for 6 months. Donors were allowed to choose either option, both, or neither.

The researchers measured ferritin, soluble transferrin receptor, and complete blood count at each donation.

Study completion

Of the 692 subjects randomized, 393 completed a final visit. The researchers noted that a donor’s ferritin level at enrollment, race, or gender did not impact study completion. However, older subjects were more likely to complete the study.

In all, 116 subjects were lost to follow-up, and the numbers were similar between the study arms. Thirty-nine subjects discontinued due to adverse events—16 in the 38 mg iron group, 12 in the 19 mg iron group, and 11 in the placebo group.

And 144 subjects discontinued for “other reasons”—9 in the iron status letter arm, 10 in the control letter arm, 30 in the 38 mg iron arm, 42 in the 19 mg iron arm, and 53 in the placebo arm.

Subjects’ reasons for discontinuation included not wanting to take a pill every day, believing they are in the placebo group and wanting to take iron, and subjects’ physicians recommending they start taking iron.

“Donors in pill arms de-enrolled more frequently than those in the letter arms, and the important thing to remember is that this is a controlled, randomized study where the donors did not know what they were taking,” Dr Mast said. “And I think that, a lot of the time, if donors had known what they were taking, they might have continued to participate in the study or continued to take the pills.”

Results

Dr Mast noted that, at the study’s end, all measures of iron deficiency were statistically indistinguishable in the 3 intervention arms, which were statistically different from the 2 control arms.

Between study enrollment and the donors’ final visit, the prevalence of ferritin <26 mg/L was unchanged in the control groups. But it had declined by more than 50% in the 3 intervention groups—19 mg iron, 38 mg iron, and iron status letter (P<0.0001 for all 3).

The prevalence of ferritin <12 mg/L was unchanged in the 2 control arms, but it had declined by more than 70% in the 3 intervention arms—19 mg iron (P<0.0001), 38 mg iron (P<0.01), and iron status letter (P<0.0001).

The researchers also calculated the odds ratios for iron deficiency over all donor visits. The odds for ferritin <26 or <12 mg/L decreased more than 80% in the 19 mg iron group (P<0.01 for both ferritin measurements) and the 38 mg iron group (P<0.01 for both).

The odds for ferritin <26 or <12 mg/L decreased about 50% in the iron status letter arm (P<0.01 for both).

And the odds for ferritin <12 mg/L increased about 50% in the control groups (P<0.01 for both the placebo and control letter groups). However, there was no significant difference for ferritin <26 mg/L in either control group.

Lastly, the researchers performed longitudinal modeling of hemoglobin. They found that hemoglobin increased >0.03 g/dL in the 19 mg and 38 mg iron arms (P<0.01 for both), decreasing the odds for low hemoglobin deferral about 50%.

Hemoglobin decreased >0.3 g/dL in the control groups (P<0.0001 for both the placebo and control letter groups), increasing the odds for low hemoglobin deferral about 70%.

“Interestingly, [being] in the iron status letter group did not affect hemoglobin that much in the longitudinal modeling of the donors,” Dr Mast noted.

In closing, he pointed out that the 19 mg and 38 mg iron pills were equally effective for mitigating iron deficiency and improving hemoglobin in these blood donors.

“From a physiology point of view, I think this is one of the most important results of this study,” Dr Mast said. “There’s absolutely no difference. There was no trend for 38 mg to be better than 19 in any analysis that we did.”

“There’s lots of reasons that could be happening, but I think it’s scientifically interesting and operationally interesting. And it’s important because we can tell donors—ask them to take a multivitamin with 19 mg of iron, and that will be sufficient to treat iron deficiency.”

Blood donation in progress

ANAHEIM, CA—Data from the STRIDE study have revealed interventions that can mitigate iron deficiency in repeat blood donors.

The study showed that providing repeat blood donors with iron supplements significantly improved their iron status.

But informing donors about their ferritin levels and recommending they take iron pills also significantly improved their iron status.

Meanwhile, patients in control groups became more iron-deficient over the study period.

The study also revealed no difference in ferritin or hemoglobin levels between patients who took 19 mg of iron and those who took 38 mg.

Alan E. Mast, MD, PhD, of the Blood Center of Wisconsin in Milwaukee, presented these results at the 2015 AABB Annual Meeting (abstract S34-030E).

Dr Mast said blood donation removes a lot of iron, and iron is used to make hemoglobin in new red blood cells. But the measurement of hemoglobin does not accurately reflect iron stores.

“That’s really important,” he said. “The only test we do to qualify a blood donor doesn’t tell us if they have iron deficiency or not. And because of that, many regular blood donors become iron-deficient and continue to donate blood.”

Dr Mast said the strategies that appear to mitigate iron deficiency in regular blood donors are oral iron supplements and delaying the donation interval for more than 6 months.

“[However,] the effectiveness of providing iron pills versus providing the donor with information about their iron status has not been previously examined,” he noted.

This was the goal of the STRIDE (Strategies to Reduce Iron Deficiency) study.

Study design

This blinded, randomized, placebo-controlled study enrolled 692 frequent blood donors from 3 blood centers. They were assigned to 1 of 5 arms for 2 years of follow-up.

In 3 arms, donors received pills for 60 days after each donation. They received 38 mg or 19 mg of elemental iron, or they received a placebo.

Donors in the remaining 2 arms received letters after each donation—either a letter informing them of their iron status or a “control” letter thanking them for donating blood and urging them to donate again.

Every iron status letter reported the donor’s ferritin level. If the level was >26 mg/L, the letter simply urged donors to donate again. If the ferritin level was ≤26 mg/L, the letter recommended taking a self-purchased iron supplement (17 mg to 38 mg) and/or delaying donation for 6 months. Donors were allowed to choose either option, both, or neither.

The researchers measured ferritin, soluble transferrin receptor, and complete blood count at each donation.

Study completion

Of the 692 subjects randomized, 393 completed a final visit. The researchers noted that a donor’s ferritin level at enrollment, race, or gender did not impact study completion. However, older subjects were more likely to complete the study.

In all, 116 subjects were lost to follow-up, and the numbers were similar between the study arms. Thirty-nine subjects discontinued due to adverse events—16 in the 38 mg iron group, 12 in the 19 mg iron group, and 11 in the placebo group.

And 144 subjects discontinued for “other reasons”—9 in the iron status letter arm, 10 in the control letter arm, 30 in the 38 mg iron arm, 42 in the 19 mg iron arm, and 53 in the placebo arm.

Subjects’ reasons for discontinuation included not wanting to take a pill every day, believing they are in the placebo group and wanting to take iron, and subjects’ physicians recommending they start taking iron.

“Donors in pill arms de-enrolled more frequently than those in the letter arms, and the important thing to remember is that this is a controlled, randomized study where the donors did not know what they were taking,” Dr Mast said. “And I think that, a lot of the time, if donors had known what they were taking, they might have continued to participate in the study or continued to take the pills.”

Results

Dr Mast noted that, at the study’s end, all measures of iron deficiency were statistically indistinguishable in the 3 intervention arms, which were statistically different from the 2 control arms.

Between study enrollment and the donors’ final visit, the prevalence of ferritin <26 mg/L was unchanged in the control groups. But it had declined by more than 50% in the 3 intervention groups—19 mg iron, 38 mg iron, and iron status letter (P<0.0001 for all 3).

The prevalence of ferritin <12 mg/L was unchanged in the 2 control arms, but it had declined by more than 70% in the 3 intervention arms—19 mg iron (P<0.0001), 38 mg iron (P<0.01), and iron status letter (P<0.0001).

The researchers also calculated the odds ratios for iron deficiency over all donor visits. The odds for ferritin <26 or <12 mg/L decreased more than 80% in the 19 mg iron group (P<0.01 for both ferritin measurements) and the 38 mg iron group (P<0.01 for both).

The odds for ferritin <26 or <12 mg/L decreased about 50% in the iron status letter arm (P<0.01 for both).

And the odds for ferritin <12 mg/L increased about 50% in the control groups (P<0.01 for both the placebo and control letter groups). However, there was no significant difference for ferritin <26 mg/L in either control group.

Lastly, the researchers performed longitudinal modeling of hemoglobin. They found that hemoglobin increased >0.03 g/dL in the 19 mg and 38 mg iron arms (P<0.01 for both), decreasing the odds for low hemoglobin deferral about 50%.

Hemoglobin decreased >0.3 g/dL in the control groups (P<0.0001 for both the placebo and control letter groups), increasing the odds for low hemoglobin deferral about 70%.

“Interestingly, [being] in the iron status letter group did not affect hemoglobin that much in the longitudinal modeling of the donors,” Dr Mast noted.

In closing, he pointed out that the 19 mg and 38 mg iron pills were equally effective for mitigating iron deficiency and improving hemoglobin in these blood donors.

“From a physiology point of view, I think this is one of the most important results of this study,” Dr Mast said. “There’s absolutely no difference. There was no trend for 38 mg to be better than 19 in any analysis that we did.”

“There’s lots of reasons that could be happening, but I think it’s scientifically interesting and operationally interesting. And it’s important because we can tell donors—ask them to take a multivitamin with 19 mg of iron, and that will be sufficient to treat iron deficiency.”

Blood donation in progress

ANAHEIM, CA—Data from the STRIDE study have revealed interventions that can mitigate iron deficiency in repeat blood donors.

The study showed that providing repeat blood donors with iron supplements significantly improved their iron status.

But informing donors about their ferritin levels and recommending they take iron pills also significantly improved their iron status.

Meanwhile, patients in control groups became more iron-deficient over the study period.

The study also revealed no difference in ferritin or hemoglobin levels between patients who took 19 mg of iron and those who took 38 mg.

Alan E. Mast, MD, PhD, of the Blood Center of Wisconsin in Milwaukee, presented these results at the 2015 AABB Annual Meeting (abstract S34-030E).

Dr Mast said blood donation removes a lot of iron, and iron is used to make hemoglobin in new red blood cells. But the measurement of hemoglobin does not accurately reflect iron stores.

“That’s really important,” he said. “The only test we do to qualify a blood donor doesn’t tell us if they have iron deficiency or not. And because of that, many regular blood donors become iron-deficient and continue to donate blood.”

Dr Mast said the strategies that appear to mitigate iron deficiency in regular blood donors are oral iron supplements and delaying the donation interval for more than 6 months.

“[However,] the effectiveness of providing iron pills versus providing the donor with information about their iron status has not been previously examined,” he noted.

This was the goal of the STRIDE (Strategies to Reduce Iron Deficiency) study.

Study design

This blinded, randomized, placebo-controlled study enrolled 692 frequent blood donors from 3 blood centers. They were assigned to 1 of 5 arms for 2 years of follow-up.

In 3 arms, donors received pills for 60 days after each donation. They received 38 mg or 19 mg of elemental iron, or they received a placebo.

Donors in the remaining 2 arms received letters after each donation—either a letter informing them of their iron status or a “control” letter thanking them for donating blood and urging them to donate again.

Every iron status letter reported the donor’s ferritin level. If the level was >26 mg/L, the letter simply urged donors to donate again. If the ferritin level was ≤26 mg/L, the letter recommended taking a self-purchased iron supplement (17 mg to 38 mg) and/or delaying donation for 6 months. Donors were allowed to choose either option, both, or neither.

The researchers measured ferritin, soluble transferrin receptor, and complete blood count at each donation.

Study completion

Of the 692 subjects randomized, 393 completed a final visit. The researchers noted that a donor’s ferritin level at enrollment, race, or gender did not impact study completion. However, older subjects were more likely to complete the study.

In all, 116 subjects were lost to follow-up, and the numbers were similar between the study arms. Thirty-nine subjects discontinued due to adverse events—16 in the 38 mg iron group, 12 in the 19 mg iron group, and 11 in the placebo group.

And 144 subjects discontinued for “other reasons”—9 in the iron status letter arm, 10 in the control letter arm, 30 in the 38 mg iron arm, 42 in the 19 mg iron arm, and 53 in the placebo arm.

Subjects’ reasons for discontinuation included not wanting to take a pill every day, believing they are in the placebo group and wanting to take iron, and subjects’ physicians recommending they start taking iron.

“Donors in pill arms de-enrolled more frequently than those in the letter arms, and the important thing to remember is that this is a controlled, randomized study where the donors did not know what they were taking,” Dr Mast said. “And I think that, a lot of the time, if donors had known what they were taking, they might have continued to participate in the study or continued to take the pills.”

Results

Dr Mast noted that, at the study’s end, all measures of iron deficiency were statistically indistinguishable in the 3 intervention arms, which were statistically different from the 2 control arms.

Between study enrollment and the donors’ final visit, the prevalence of ferritin <26 mg/L was unchanged in the control groups. But it had declined by more than 50% in the 3 intervention groups—19 mg iron, 38 mg iron, and iron status letter (P<0.0001 for all 3).

The prevalence of ferritin <12 mg/L was unchanged in the 2 control arms, but it had declined by more than 70% in the 3 intervention arms—19 mg iron (P<0.0001), 38 mg iron (P<0.01), and iron status letter (P<0.0001).

The researchers also calculated the odds ratios for iron deficiency over all donor visits. The odds for ferritin <26 or <12 mg/L decreased more than 80% in the 19 mg iron group (P<0.01 for both ferritin measurements) and the 38 mg iron group (P<0.01 for both).

The odds for ferritin <26 or <12 mg/L decreased about 50% in the iron status letter arm (P<0.01 for both).

And the odds for ferritin <12 mg/L increased about 50% in the control groups (P<0.01 for both the placebo and control letter groups). However, there was no significant difference for ferritin <26 mg/L in either control group.

Lastly, the researchers performed longitudinal modeling of hemoglobin. They found that hemoglobin increased >0.03 g/dL in the 19 mg and 38 mg iron arms (P<0.01 for both), decreasing the odds for low hemoglobin deferral about 50%.

Hemoglobin decreased >0.3 g/dL in the control groups (P<0.0001 for both the placebo and control letter groups), increasing the odds for low hemoglobin deferral about 70%.

“Interestingly, [being] in the iron status letter group did not affect hemoglobin that much in the longitudinal modeling of the donors,” Dr Mast noted.

In closing, he pointed out that the 19 mg and 38 mg iron pills were equally effective for mitigating iron deficiency and improving hemoglobin in these blood donors.

“From a physiology point of view, I think this is one of the most important results of this study,” Dr Mast said. “There’s absolutely no difference. There was no trend for 38 mg to be better than 19 in any analysis that we did.”

“There’s lots of reasons that could be happening, but I think it’s scientifically interesting and operationally interesting. And it’s important because we can tell donors—ask them to take a multivitamin with 19 mg of iron, and that will be sufficient to treat iron deficiency.”