Blood Banking

The Swiss Agency for Therapeutic Products (Swissmedic) has agreed to lift the ban on blood donations from men who have sex with men (MSM).

Instead, MSMs will be allowed to donate blood if it has been at least 12 months since their last sexual contact with another man.

Swiss Transfusion SRC Inc. expects to implement the modified donation criteria for MSMs in regional blood transfusion services starting in mid-2017.

However, Swissmedic’s decision is subject to certain conditions.

Specifically, blood transfusion services will have to record additional data on the effects of the modified donation criteria and donors’ compliance with them, as well as closely monitor the risk trend.

Swissmedic said that, since January 2016, the tests for specific pathogens in donated blood in Switzerland have been further refined, resulting in a higher level of sensitivity.

The diagnostic window—the period in which any infections carried by blood donors cannot yet be discovered—for the relevant pathogens has been further narrowed. Depending on the virus, the diagnostic window is 3 days to 15 days after infection.

Therefore, Swissmedic believes that a 12-month deferral period for MSM blood donors would not expose recipients of blood transfusions to an increased risk of contracting a blood-borne infection.

Swissmedic noted that approximately half of all new HIV infections in Switzerland are attributable to MSMs. This is one of the reasons MSMs have been permanently excluded from giving blood since 1977.

The new 12-month deferral period for MSMs is in line with the precautionary measures applicable to various other behaviors that have been shown to increase the risk of HIV transmission, such as changing sexual partners, staying in countries with a high AIDS rate, and sexual contact with partners who have stayed in countries with a high AIDS rate for a lengthy period.

The change to a 1-year deferral period for MSM blood donors brings Switzerland into line with other nations that have adopted similar policies, such as Ireland, Canada, the US, and the UK.

The Swiss Agency for Therapeutic Products (Swissmedic) has agreed to lift the ban on blood donations from men who have sex with men (MSM).

Instead, MSMs will be allowed to donate blood if it has been at least 12 months since their last sexual contact with another man.

Swiss Transfusion SRC Inc. expects to implement the modified donation criteria for MSMs in regional blood transfusion services starting in mid-2017.

However, Swissmedic’s decision is subject to certain conditions.

Specifically, blood transfusion services will have to record additional data on the effects of the modified donation criteria and donors’ compliance with them, as well as closely monitor the risk trend.

Swissmedic said that, since January 2016, the tests for specific pathogens in donated blood in Switzerland have been further refined, resulting in a higher level of sensitivity.

The diagnostic window—the period in which any infections carried by blood donors cannot yet be discovered—for the relevant pathogens has been further narrowed. Depending on the virus, the diagnostic window is 3 days to 15 days after infection.

Therefore, Swissmedic believes that a 12-month deferral period for MSM blood donors would not expose recipients of blood transfusions to an increased risk of contracting a blood-borne infection.

Swissmedic noted that approximately half of all new HIV infections in Switzerland are attributable to MSMs. This is one of the reasons MSMs have been permanently excluded from giving blood since 1977.

The new 12-month deferral period for MSMs is in line with the precautionary measures applicable to various other behaviors that have been shown to increase the risk of HIV transmission, such as changing sexual partners, staying in countries with a high AIDS rate, and sexual contact with partners who have stayed in countries with a high AIDS rate for a lengthy period.

The change to a 1-year deferral period for MSM blood donors brings Switzerland into line with other nations that have adopted similar policies, such as Ireland, Canada, the US, and the UK.

The Swiss Agency for Therapeutic Products (Swissmedic) has agreed to lift the ban on blood donations from men who have sex with men (MSM).

Instead, MSMs will be allowed to donate blood if it has been at least 12 months since their last sexual contact with another man.

Swiss Transfusion SRC Inc. expects to implement the modified donation criteria for MSMs in regional blood transfusion services starting in mid-2017.

However, Swissmedic’s decision is subject to certain conditions.

Specifically, blood transfusion services will have to record additional data on the effects of the modified donation criteria and donors’ compliance with them, as well as closely monitor the risk trend.

Swissmedic said that, since January 2016, the tests for specific pathogens in donated blood in Switzerland have been further refined, resulting in a higher level of sensitivity.

The diagnostic window—the period in which any infections carried by blood donors cannot yet be discovered—for the relevant pathogens has been further narrowed. Depending on the virus, the diagnostic window is 3 days to 15 days after infection.

Therefore, Swissmedic believes that a 12-month deferral period for MSM blood donors would not expose recipients of blood transfusions to an increased risk of contracting a blood-borne infection.

Swissmedic noted that approximately half of all new HIV infections in Switzerland are attributable to MSMs. This is one of the reasons MSMs have been permanently excluded from giving blood since 1977.

The new 12-month deferral period for MSMs is in line with the precautionary measures applicable to various other behaviors that have been shown to increase the risk of HIV transmission, such as changing sexual partners, staying in countries with a high AIDS rate, and sexual contact with partners who have stayed in countries with a high AIDS rate for a lengthy period.

The change to a 1-year deferral period for MSM blood donors brings Switzerland into line with other nations that have adopted similar policies, such as Ireland, Canada, the US, and the UK.

Roche has announced the launch of its cobas m 511 integrated hematology analyzer in countries that recognize the CE mark.*

The cobas m 511 combines 3 components of the hematology testing process—a digital morphology analyzer, cell counter, and classifier—into a single system that prepares, stains, and analyzes microscopy blood slides.

Roche said cobas m 511 provides greater accuracy and consistency than current technologies by identifying, counting, isolating, and categorizing blood cells, then presenting the digital images of all these cell types.

The company said this automation and digitalization reduces the need for resource-intensive manual microscope reviews, supports clinicians to share challenging cases around the world, and enables the delivery of quicker results, which ultimately aid patient diagnoses.

The cobas m 511 uses Bloodhound® technology for printing, staining, and imaging. This technology uses 30 µL of blood to print a monolayer onto the slide, stains for further analysis of the morphology, and enables classification of cells displayed on a viewing station.

Unlike the indirect methods commonly used in blood analysis today, the cobas m 511 images individual cells directly.

Based on these direct images, the Bloodhound® technology counts, analyzes morphology, and then classifies every cell in the viewing area to provide a standard complete blood count and 5-part differential and reticulocyte count.

While hematologists will continue to have the option of looking at slides under their microscopes, the cobas m 511 provides cell-by-cell images that, in many cases, may eliminate the need for microscopic review.

“With this launch, patients will benefit from a faster and more accurate diagnosis of blood diseases as diverse as anemia and leukemia,” said Roland Diggelmann, CEO of Roche Diagnostics.

“We are entering a new area of innovation with Roche in hematology testing, supporting customers with integrated and efficient laboratory solutions, which deliver increased medical value.”

*Local product availability may vary independently from CE mark approval. The cobas m 511 integrated hematology analyzer is not available in countries with previously agreed third-party vendor agreements.

Roche has announced the launch of its cobas m 511 integrated hematology analyzer in countries that recognize the CE mark.*

The cobas m 511 combines 3 components of the hematology testing process—a digital morphology analyzer, cell counter, and classifier—into a single system that prepares, stains, and analyzes microscopy blood slides.

Roche said cobas m 511 provides greater accuracy and consistency than current technologies by identifying, counting, isolating, and categorizing blood cells, then presenting the digital images of all these cell types.

The company said this automation and digitalization reduces the need for resource-intensive manual microscope reviews, supports clinicians to share challenging cases around the world, and enables the delivery of quicker results, which ultimately aid patient diagnoses.

The cobas m 511 uses Bloodhound® technology for printing, staining, and imaging. This technology uses 30 µL of blood to print a monolayer onto the slide, stains for further analysis of the morphology, and enables classification of cells displayed on a viewing station.

Unlike the indirect methods commonly used in blood analysis today, the cobas m 511 images individual cells directly.

Based on these direct images, the Bloodhound® technology counts, analyzes morphology, and then classifies every cell in the viewing area to provide a standard complete blood count and 5-part differential and reticulocyte count.

While hematologists will continue to have the option of looking at slides under their microscopes, the cobas m 511 provides cell-by-cell images that, in many cases, may eliminate the need for microscopic review.

“With this launch, patients will benefit from a faster and more accurate diagnosis of blood diseases as diverse as anemia and leukemia,” said Roland Diggelmann, CEO of Roche Diagnostics.

“We are entering a new area of innovation with Roche in hematology testing, supporting customers with integrated and efficient laboratory solutions, which deliver increased medical value.”

*Local product availability may vary independently from CE mark approval. The cobas m 511 integrated hematology analyzer is not available in countries with previously agreed third-party vendor agreements.

Roche has announced the launch of its cobas m 511 integrated hematology analyzer in countries that recognize the CE mark.*

The cobas m 511 combines 3 components of the hematology testing process—a digital morphology analyzer, cell counter, and classifier—into a single system that prepares, stains, and analyzes microscopy blood slides.

Roche said cobas m 511 provides greater accuracy and consistency than current technologies by identifying, counting, isolating, and categorizing blood cells, then presenting the digital images of all these cell types.

The company said this automation and digitalization reduces the need for resource-intensive manual microscope reviews, supports clinicians to share challenging cases around the world, and enables the delivery of quicker results, which ultimately aid patient diagnoses.

The cobas m 511 uses Bloodhound® technology for printing, staining, and imaging. This technology uses 30 µL of blood to print a monolayer onto the slide, stains for further analysis of the morphology, and enables classification of cells displayed on a viewing station.

Unlike the indirect methods commonly used in blood analysis today, the cobas m 511 images individual cells directly.

Based on these direct images, the Bloodhound® technology counts, analyzes morphology, and then classifies every cell in the viewing area to provide a standard complete blood count and 5-part differential and reticulocyte count.

While hematologists will continue to have the option of looking at slides under their microscopes, the cobas m 511 provides cell-by-cell images that, in many cases, may eliminate the need for microscopic review.

“With this launch, patients will benefit from a faster and more accurate diagnosis of blood diseases as diverse as anemia and leukemia,” said Roland Diggelmann, CEO of Roche Diagnostics.

“We are entering a new area of innovation with Roche in hematology testing, supporting customers with integrated and efficient laboratory solutions, which deliver increased medical value.”

*Local product availability may vary independently from CE mark approval. The cobas m 511 integrated hematology analyzer is not available in countries with previously agreed third-party vendor agreements.

The Irish Blood Transfusion Service (IBTS) has lifted the lifetime ban on blood donations from men who have sex with men (MSM).

However, prospective MSM blood donors are still subject to deferral.

Now, MSMs are allowed to donate blood in Ireland if it has been more than 12 months since their last sexual contact with a man and if they meet the other blood donor selection criteria.

The IBTS has also introduced new regulations relating to individuals with a history of specific, notifiable sexually transmitted infections (STIs).

These individuals are now allowed to donate blood 5 years after they have completed treatment for their STIs.

“In June of last year, I accepted the recommendations of the IBTS to change their blood donation deferral policies for men who have sex with men, as well as for donors who have had a sexually transmitted infection,” said Ireland’s Health Minister, Simon Harris.

“I would like to take this opportunity to thank the IBTS for their work over the past 6 months, which, today, sees these recommendations brought to fruition within the timescale agreed. [T]he IBTS will continue to keep all deferral policies under active review in the light of scientific evidence, emerging infections, and international experience.”

MSM deferral

The change in deferral policy relating to MSMs follows a 2-year review of the issues by the IBTS.

The agency hosted an international symposium on the topic in April 2016. Experts from 7 countries who had either lifted, or were in the process of lifting, their lifetime ban on MSM blood donors presented their respective stances, research, and the rationale behind their decisions.

The IBTS said its change to a 1-year deferral period for MSMs is supported by the most current scientific evidence available and brings Ireland into line with similar policies in the UK, Canada, and the US.

STI-related deferral

The IBTS said the 1-year deferral policy for MSMs will protect against the risk of HIV transmission. However, there is concern that it may not be sufficient to deal with an emerging infection. 

Therefore, the board of the IBTS decided that individuals who have had a notifiable STI, such as chlamydia or genital herpes, should be deferred from donating blood for 5 years after completing treatment for that STI.  

Individuals who have had syphilis, gonorrhea, lymphogranuloma venereum, or granuloma inguinale are (and have been) permanently banned from donating blood.

Individuals who have taken medication to prevent HIV infection are also deferred from donating blood for 5 years after they take the medication.

Safety of the blood supply

“The IBTS provides a safe, reliable, and robust blood service to the Irish health system and has the necessary program and procedures in place to protect both donors and recipients of blood and blood products,” Harris said.

All prospective blood donors in Ireland undergo nucleic acid testing for a number of diseases, including HIV, hepatitis B, and hepatitis C. This is the most sensitive method of testing available.

The risk of transmitted infection of blood is at its highest when individuals donate blood during the 5- to 15-day period following exposure to a virus.

There is no biological measure to detect infectivity during this period and, as a consequence, the IBTS temporarily or permanently defers, on average, 1 in 10 people from giving blood.

The Irish Blood Transfusion Service (IBTS) has lifted the lifetime ban on blood donations from men who have sex with men (MSM).

However, prospective MSM blood donors are still subject to deferral.

Now, MSMs are allowed to donate blood in Ireland if it has been more than 12 months since their last sexual contact with a man and if they meet the other blood donor selection criteria.

The IBTS has also introduced new regulations relating to individuals with a history of specific, notifiable sexually transmitted infections (STIs).

These individuals are now allowed to donate blood 5 years after they have completed treatment for their STIs.

“In June of last year, I accepted the recommendations of the IBTS to change their blood donation deferral policies for men who have sex with men, as well as for donors who have had a sexually transmitted infection,” said Ireland’s Health Minister, Simon Harris.

“I would like to take this opportunity to thank the IBTS for their work over the past 6 months, which, today, sees these recommendations brought to fruition within the timescale agreed. [T]he IBTS will continue to keep all deferral policies under active review in the light of scientific evidence, emerging infections, and international experience.”

MSM deferral

The change in deferral policy relating to MSMs follows a 2-year review of the issues by the IBTS.

The agency hosted an international symposium on the topic in April 2016. Experts from 7 countries who had either lifted, or were in the process of lifting, their lifetime ban on MSM blood donors presented their respective stances, research, and the rationale behind their decisions.

The IBTS said its change to a 1-year deferral period for MSMs is supported by the most current scientific evidence available and brings Ireland into line with similar policies in the UK, Canada, and the US.

STI-related deferral

The IBTS said the 1-year deferral policy for MSMs will protect against the risk of HIV transmission. However, there is concern that it may not be sufficient to deal with an emerging infection. 

Therefore, the board of the IBTS decided that individuals who have had a notifiable STI, such as chlamydia or genital herpes, should be deferred from donating blood for 5 years after completing treatment for that STI.  

Individuals who have had syphilis, gonorrhea, lymphogranuloma venereum, or granuloma inguinale are (and have been) permanently banned from donating blood.

Individuals who have taken medication to prevent HIV infection are also deferred from donating blood for 5 years after they take the medication.

Safety of the blood supply

“The IBTS provides a safe, reliable, and robust blood service to the Irish health system and has the necessary program and procedures in place to protect both donors and recipients of blood and blood products,” Harris said.

All prospective blood donors in Ireland undergo nucleic acid testing for a number of diseases, including HIV, hepatitis B, and hepatitis C. This is the most sensitive method of testing available.

The risk of transmitted infection of blood is at its highest when individuals donate blood during the 5- to 15-day period following exposure to a virus.

There is no biological measure to detect infectivity during this period and, as a consequence, the IBTS temporarily or permanently defers, on average, 1 in 10 people from giving blood.

The Irish Blood Transfusion Service (IBTS) has lifted the lifetime ban on blood donations from men who have sex with men (MSM).

However, prospective MSM blood donors are still subject to deferral.

Now, MSMs are allowed to donate blood in Ireland if it has been more than 12 months since their last sexual contact with a man and if they meet the other blood donor selection criteria.

The IBTS has also introduced new regulations relating to individuals with a history of specific, notifiable sexually transmitted infections (STIs).

These individuals are now allowed to donate blood 5 years after they have completed treatment for their STIs.

“In June of last year, I accepted the recommendations of the IBTS to change their blood donation deferral policies for men who have sex with men, as well as for donors who have had a sexually transmitted infection,” said Ireland’s Health Minister, Simon Harris.

“I would like to take this opportunity to thank the IBTS for their work over the past 6 months, which, today, sees these recommendations brought to fruition within the timescale agreed. [T]he IBTS will continue to keep all deferral policies under active review in the light of scientific evidence, emerging infections, and international experience.”

MSM deferral

The change in deferral policy relating to MSMs follows a 2-year review of the issues by the IBTS.

The agency hosted an international symposium on the topic in April 2016. Experts from 7 countries who had either lifted, or were in the process of lifting, their lifetime ban on MSM blood donors presented their respective stances, research, and the rationale behind their decisions.

The IBTS said its change to a 1-year deferral period for MSMs is supported by the most current scientific evidence available and brings Ireland into line with similar policies in the UK, Canada, and the US.

STI-related deferral

The IBTS said the 1-year deferral policy for MSMs will protect against the risk of HIV transmission. However, there is concern that it may not be sufficient to deal with an emerging infection. 

Therefore, the board of the IBTS decided that individuals who have had a notifiable STI, such as chlamydia or genital herpes, should be deferred from donating blood for 5 years after completing treatment for that STI.  

Individuals who have had syphilis, gonorrhea, lymphogranuloma venereum, or granuloma inguinale are (and have been) permanently banned from donating blood.

Individuals who have taken medication to prevent HIV infection are also deferred from donating blood for 5 years after they take the medication.

Safety of the blood supply

“The IBTS provides a safe, reliable, and robust blood service to the Irish health system and has the necessary program and procedures in place to protect both donors and recipients of blood and blood products,” Harris said.

All prospective blood donors in Ireland undergo nucleic acid testing for a number of diseases, including HIV, hepatitis B, and hepatitis C. This is the most sensitive method of testing available.

The risk of transmitted infection of blood is at its highest when individuals donate blood during the 5- to 15-day period following exposure to a virus.

There is no biological measure to detect infectivity during this period and, as a consequence, the IBTS temporarily or permanently defers, on average, 1 in 10 people from giving blood.

Abbott’s Alinity s System for blood and plasma screening has received the CE mark and is now available for use in countries that recognize the mark.

The Alinity s System is designed to screen blood and plasma faster and more efficiently than Abbott’s current systems.

The company said the additional automation and flexibility of the Alinity s System helps blood and plasma centers improve productivity and maintain accuracy without expanding the instrument footprint.

According to Abbott, the Alinity s System offers a number of new features. It expands capacity to run up to 600 tests per hour, and it increases walk-away time to a minimum of 3 hours.

The system also gives laboratory professionals the ability to continuously load and

unload samples and supplies without pausing or stopping the system.

The Alinity s System improves centers’ ability to track all activities and actions associated with the testing and processing of each donation in accordance with relevant legislation and requirements.

And the system features an intuitive software interface, menu design, and sample loading layout (shared with other Alinity instruments), making it easy for lab technicians to learn and use.

“When Abbott developed the Alinity s System, we considered the challenges that blood and plasma centers face today as well as in the future, such as adequate space, easier training, and more time for lab professionals to work away from the instrument,” said Daman Kowalski, divisional vice president of new product development in diagnostics at Abbott.

“In addressing these challenges, the Alinity s System has the potential to transform how quickly and accurately these centers can screen blood and plasma, which means we can deliver life-saving blood components to the people who need it the most.”

Abbott’s Alinity s System for blood and plasma screening has received the CE mark and is now available for use in countries that recognize the mark.

The Alinity s System is designed to screen blood and plasma faster and more efficiently than Abbott’s current systems.

The company said the additional automation and flexibility of the Alinity s System helps blood and plasma centers improve productivity and maintain accuracy without expanding the instrument footprint.

According to Abbott, the Alinity s System offers a number of new features. It expands capacity to run up to 600 tests per hour, and it increases walk-away time to a minimum of 3 hours.

The system also gives laboratory professionals the ability to continuously load and

unload samples and supplies without pausing or stopping the system.

The Alinity s System improves centers’ ability to track all activities and actions associated with the testing and processing of each donation in accordance with relevant legislation and requirements.

And the system features an intuitive software interface, menu design, and sample loading layout (shared with other Alinity instruments), making it easy for lab technicians to learn and use.

“When Abbott developed the Alinity s System, we considered the challenges that blood and plasma centers face today as well as in the future, such as adequate space, easier training, and more time for lab professionals to work away from the instrument,” said Daman Kowalski, divisional vice president of new product development in diagnostics at Abbott.

“In addressing these challenges, the Alinity s System has the potential to transform how quickly and accurately these centers can screen blood and plasma, which means we can deliver life-saving blood components to the people who need it the most.”

Abbott’s Alinity s System for blood and plasma screening has received the CE mark and is now available for use in countries that recognize the mark.

The Alinity s System is designed to screen blood and plasma faster and more efficiently than Abbott’s current systems.

The company said the additional automation and flexibility of the Alinity s System helps blood and plasma centers improve productivity and maintain accuracy without expanding the instrument footprint.

According to Abbott, the Alinity s System offers a number of new features. It expands capacity to run up to 600 tests per hour, and it increases walk-away time to a minimum of 3 hours.

The system also gives laboratory professionals the ability to continuously load and

unload samples and supplies without pausing or stopping the system.

The Alinity s System improves centers’ ability to track all activities and actions associated with the testing and processing of each donation in accordance with relevant legislation and requirements.

And the system features an intuitive software interface, menu design, and sample loading layout (shared with other Alinity instruments), making it easy for lab technicians to learn and use.

“When Abbott developed the Alinity s System, we considered the challenges that blood and plasma centers face today as well as in the future, such as adequate space, easier training, and more time for lab professionals to work away from the instrument,” said Daman Kowalski, divisional vice president of new product development in diagnostics at Abbott.

“In addressing these challenges, the Alinity s System has the potential to transform how quickly and accurately these centers can screen blood and plasma, which means we can deliver life-saving blood components to the people who need it the most.”

Transfusions of blood that has been stored for 6 weeks can release large and potentially harmful amounts of iron into patients’ bloodstreams, a new study suggests.

Based on these findings, researchers are recommending the US Food and Drug Administration (FDA) reduce the maximum storage limit of red blood cells (RBCs) from 6 weeks to 5 weeks, as long as there is a sufficient supply of blood.

“Our recommendation will be controversial, but we think we have real data to support it,” said study author Steven Spitalnik, MD, of Columbia University College of Physicians and Surgeons — New York Presbyterian Hospital in New York, New York.

“Recent studies have concluded that transfusing old blood has no impact on patient outcomes, but those studies didn’t exclusively examine the oldest blood available for transfusions. Our new study found a real problem when transfusing blood that’s older than 5 weeks.”

Dr Spitalnik and his colleagues described their study in The Journal of Clinical Investigation.

The researchers randomly assigned a group of 60 healthy volunteers to receive a unit of RBCs that had been stored for 1, 2, 3, 4, 5, or 6 weeks. The volunteers were then monitored for 20 hours after transfusion.

The researchers found that a longer duration of RBC storage was associated with a progressive increase in extravascular hemolysis, decreasing post-transfusion RBC recovery, decreasing elevations in hematocrit, and increasing serum ferritin.

None of the volunteers were harmed by the transfusions, but subjects who received 6-week-old blood had outcomes associated with an increased risk of harm.

In 7 of the 9 subjects who received the 6-week-old blood (78%), the amount of iron entering the circulation exceeded the iron-uptake capacity of transferrin, producing circulating nontransferrin-bound iron. The same effect occurred in 1 of the 10 subjects who received 5-week-old blood (10%, P=0.003).

The area under the curve of the change in nontransferrin-bound iron was significantly higher for subjects who received the 6-week-old blood than for all other subjects (P<0.001). The same was true for serum iron (P<0.01) and transferrin saturation (P<0.001).

“Based on the amount of iron circulating in the blood of the volunteers who received 6-week-old blood, we’d predict that certain existing infections could be exacerbated,” said study author Eldad Hod, MD, also of Columbia University College of Physicians and Surgeons — New York Presbyterian Hospital.

“Thus, for ill, hospitalized patients, this excess iron could lead to serious complications,” Dr Spitalnik added.

The researchers said the true impact of 6-week-old blood on the rate of complications is likely to be small. However, since millions of Americans receive transfusions each year, even a 1% difference in complications could affect a large number of patients.

“It’s estimated that up to 10% to 20% of blood units used for transfusions have been stored for more than 5 weeks, so the number of patients who are likely to receive a unit of very old blood is substantial,” Dr Hod noted.

“Based on our findings of potential harm, we think the prudent thing to do, at this time, is for the FDA to reduce the maximum storage period,” Dr Spitalnik added.

“The UK, Ireland, the Netherlands, and the National Institutes of Health have limited storage to 35 days, and we think that can be achieved throughout the US without seriously affecting the blood supply.”

This study was supported by grants from the National Institutes of Health (HL115557 and UL1TR000040).

Transfusions of blood that has been stored for 6 weeks can release large and potentially harmful amounts of iron into patients’ bloodstreams, a new study suggests.

Based on these findings, researchers are recommending the US Food and Drug Administration (FDA) reduce the maximum storage limit of red blood cells (RBCs) from 6 weeks to 5 weeks, as long as there is a sufficient supply of blood.

“Our recommendation will be controversial, but we think we have real data to support it,” said study author Steven Spitalnik, MD, of Columbia University College of Physicians and Surgeons — New York Presbyterian Hospital in New York, New York.

“Recent studies have concluded that transfusing old blood has no impact on patient outcomes, but those studies didn’t exclusively examine the oldest blood available for transfusions. Our new study found a real problem when transfusing blood that’s older than 5 weeks.”

Dr Spitalnik and his colleagues described their study in The Journal of Clinical Investigation.

The researchers randomly assigned a group of 60 healthy volunteers to receive a unit of RBCs that had been stored for 1, 2, 3, 4, 5, or 6 weeks. The volunteers were then monitored for 20 hours after transfusion.

The researchers found that a longer duration of RBC storage was associated with a progressive increase in extravascular hemolysis, decreasing post-transfusion RBC recovery, decreasing elevations in hematocrit, and increasing serum ferritin.

None of the volunteers were harmed by the transfusions, but subjects who received 6-week-old blood had outcomes associated with an increased risk of harm.

In 7 of the 9 subjects who received the 6-week-old blood (78%), the amount of iron entering the circulation exceeded the iron-uptake capacity of transferrin, producing circulating nontransferrin-bound iron. The same effect occurred in 1 of the 10 subjects who received 5-week-old blood (10%, P=0.003).

The area under the curve of the change in nontransferrin-bound iron was significantly higher for subjects who received the 6-week-old blood than for all other subjects (P<0.001). The same was true for serum iron (P<0.01) and transferrin saturation (P<0.001).

“Based on the amount of iron circulating in the blood of the volunteers who received 6-week-old blood, we’d predict that certain existing infections could be exacerbated,” said study author Eldad Hod, MD, also of Columbia University College of Physicians and Surgeons — New York Presbyterian Hospital.

“Thus, for ill, hospitalized patients, this excess iron could lead to serious complications,” Dr Spitalnik added.

The researchers said the true impact of 6-week-old blood on the rate of complications is likely to be small. However, since millions of Americans receive transfusions each year, even a 1% difference in complications could affect a large number of patients.

“It’s estimated that up to 10% to 20% of blood units used for transfusions have been stored for more than 5 weeks, so the number of patients who are likely to receive a unit of very old blood is substantial,” Dr Hod noted.

“Based on our findings of potential harm, we think the prudent thing to do, at this time, is for the FDA to reduce the maximum storage period,” Dr Spitalnik added.

“The UK, Ireland, the Netherlands, and the National Institutes of Health have limited storage to 35 days, and we think that can be achieved throughout the US without seriously affecting the blood supply.”

This study was supported by grants from the National Institutes of Health (HL115557 and UL1TR000040).

Transfusions of blood that has been stored for 6 weeks can release large and potentially harmful amounts of iron into patients’ bloodstreams, a new study suggests.

Based on these findings, researchers are recommending the US Food and Drug Administration (FDA) reduce the maximum storage limit of red blood cells (RBCs) from 6 weeks to 5 weeks, as long as there is a sufficient supply of blood.

“Our recommendation will be controversial, but we think we have real data to support it,” said study author Steven Spitalnik, MD, of Columbia University College of Physicians and Surgeons — New York Presbyterian Hospital in New York, New York.

“Recent studies have concluded that transfusing old blood has no impact on patient outcomes, but those studies didn’t exclusively examine the oldest blood available for transfusions. Our new study found a real problem when transfusing blood that’s older than 5 weeks.”

Dr Spitalnik and his colleagues described their study in The Journal of Clinical Investigation.

The researchers randomly assigned a group of 60 healthy volunteers to receive a unit of RBCs that had been stored for 1, 2, 3, 4, 5, or 6 weeks. The volunteers were then monitored for 20 hours after transfusion.

The researchers found that a longer duration of RBC storage was associated with a progressive increase in extravascular hemolysis, decreasing post-transfusion RBC recovery, decreasing elevations in hematocrit, and increasing serum ferritin.

None of the volunteers were harmed by the transfusions, but subjects who received 6-week-old blood had outcomes associated with an increased risk of harm.

In 7 of the 9 subjects who received the 6-week-old blood (78%), the amount of iron entering the circulation exceeded the iron-uptake capacity of transferrin, producing circulating nontransferrin-bound iron. The same effect occurred in 1 of the 10 subjects who received 5-week-old blood (10%, P=0.003).

The area under the curve of the change in nontransferrin-bound iron was significantly higher for subjects who received the 6-week-old blood than for all other subjects (P<0.001). The same was true for serum iron (P<0.01) and transferrin saturation (P<0.001).

“Based on the amount of iron circulating in the blood of the volunteers who received 6-week-old blood, we’d predict that certain existing infections could be exacerbated,” said study author Eldad Hod, MD, also of Columbia University College of Physicians and Surgeons — New York Presbyterian Hospital.

“Thus, for ill, hospitalized patients, this excess iron could lead to serious complications,” Dr Spitalnik added.

The researchers said the true impact of 6-week-old blood on the rate of complications is likely to be small. However, since millions of Americans receive transfusions each year, even a 1% difference in complications could affect a large number of patients.

“It’s estimated that up to 10% to 20% of blood units used for transfusions have been stored for more than 5 weeks, so the number of patients who are likely to receive a unit of very old blood is substantial,” Dr Hod noted.

“Based on our findings of potential harm, we think the prudent thing to do, at this time, is for the FDA to reduce the maximum storage period,” Dr Spitalnik added.

“The UK, Ireland, the Netherlands, and the National Institutes of Health have limited storage to 35 days, and we think that can be achieved throughout the US without seriously affecting the blood supply.”

This study was supported by grants from the National Institutes of Health (HL115557 and UL1TR000040).

SAN DIEGO—Researchers have developed artificial red blood cells (RBCs) that appear able to emulate functions of natural red blood cells (RBCs), at least in rodents.

The artificial RBCs, known as ErythroMer, are designed to be freeze-dried, stored at ambient temperatures, and reconstituted with water when needed.

If ErythroMer proves safe and effective in humans, it could represent an alternative to blood transfusions that might be useful in situations where donated blood is difficult to obtain or store.

“There are currently no simple, practical means to bring transfusion to most trauma victims outside of hospitals,” said Allan Doctor, MD, of Washington University in Saint Louis, Missouri.

“ErythroMer would be a blood substitute that a medic can carry in his or her pack and literally take it out, add water, and inject it.”

Dr Doctor presented details on ErythroMer at the 2016 ASH Annual Meeting (abstract 1027).

Design

“Due to significant advances in synthetic chemistry and nanomedicine, we’re now able to encapsulate biologics with programmable polymers to generate nanoparticles that can emulate normal cellular physiology,” Dr Doctor noted.

With ErythroMer, he and his colleagues encapsulated human hemoglobin, methylene blue, and 2,3-DPG in an amphiphilic polymer shell. The polymer and its payload components, through microfluidization, self-assemble into toroids that are about one-fiftieth the size of human RBCs.

ErythroMer is designed to be pH-responsive, so that, in areas of high pH, 2,3-DPG is sequestered in the inner surface of the particle shell and does not bind to hemoglobin. In areas of low pH, 2,3-DPG is released from the shell and binds to hemoglobin, facilitating oxygen offloading. The role of methylene blue is to inhibit auto-oxidation of hemoglobin.

The last step in synthesis of the particle is crosslinking of the surface, which neutralizes the surface charge, stabilizes the particle, and generates a selective diffusion barrier to nitric oxide. The particle can be lyophilized for extended storage and later reconstituted.

Testing

Tests showed that ErythroMer matches the oxygen binding feature of human RBCs within 10%, a level researchers say should be sufficient to stabilize a bleeding patient until a blood transfusion can be obtained.

Experiments in mice showed that ErythroMer captures oxygen in the lungs and releases it to tissues in a pattern that is indistinguishable from that seen in a control group of mice injected with their own blood.

In rats, ErythroMer effectively resuscitated animals in shock following acute loss of 40% of their blood volume.

So far, tests suggest ErythroMer has overcome barriers that halted the development of previous blood substitutes.

However, Dr Doctor noted that ErythroMer does have its weaknesses. The particles are cleared rapidly from the bloodstream (in 3 to 7 hours), and hemoglobin sourcing presents a challenge. The researchers are now exploring the possibility of using recombinant hemoglobin genetically engineered in yeast.

The team hopes to further optimize ErythroMer’s shell, extend circulation time, confirm the efficacy of ErythroMer in a larger animal model (rabbits), evaluate the impact of the product on the coagulation and immune systems, and scale up production.

If further testing goes well, the researchers estimate that ErythroMer could be ready for use by field medics and emergency responders within 10 to 12 years.

ErythroMer development has been supported by the Children’s Discovery Institute at Washington University and St. Louis Children’s Hospital, the Skandalaris Center at Washington University, and the BioSTL Fundamentals Program.

This research was funded by the National Institute of General Medical Sciences; the National Heart, Lung, and Blood Institute; the National Institute of Child Health and Human Development, the US Department of Defense; the American Heart Association; Doris Duke Foundation; and Children’s Discovery Institute.

SAN DIEGO—Researchers have developed artificial red blood cells (RBCs) that appear able to emulate functions of natural red blood cells (RBCs), at least in rodents.

The artificial RBCs, known as ErythroMer, are designed to be freeze-dried, stored at ambient temperatures, and reconstituted with water when needed.

If ErythroMer proves safe and effective in humans, it could represent an alternative to blood transfusions that might be useful in situations where donated blood is difficult to obtain or store.

“There are currently no simple, practical means to bring transfusion to most trauma victims outside of hospitals,” said Allan Doctor, MD, of Washington University in Saint Louis, Missouri.

“ErythroMer would be a blood substitute that a medic can carry in his or her pack and literally take it out, add water, and inject it.”

Dr Doctor presented details on ErythroMer at the 2016 ASH Annual Meeting (abstract 1027).

Design

“Due to significant advances in synthetic chemistry and nanomedicine, we’re now able to encapsulate biologics with programmable polymers to generate nanoparticles that can emulate normal cellular physiology,” Dr Doctor noted.

With ErythroMer, he and his colleagues encapsulated human hemoglobin, methylene blue, and 2,3-DPG in an amphiphilic polymer shell. The polymer and its payload components, through microfluidization, self-assemble into toroids that are about one-fiftieth the size of human RBCs.

ErythroMer is designed to be pH-responsive, so that, in areas of high pH, 2,3-DPG is sequestered in the inner surface of the particle shell and does not bind to hemoglobin. In areas of low pH, 2,3-DPG is released from the shell and binds to hemoglobin, facilitating oxygen offloading. The role of methylene blue is to inhibit auto-oxidation of hemoglobin.

The last step in synthesis of the particle is crosslinking of the surface, which neutralizes the surface charge, stabilizes the particle, and generates a selective diffusion barrier to nitric oxide. The particle can be lyophilized for extended storage and later reconstituted.

Testing

Tests showed that ErythroMer matches the oxygen binding feature of human RBCs within 10%, a level researchers say should be sufficient to stabilize a bleeding patient until a blood transfusion can be obtained.

Experiments in mice showed that ErythroMer captures oxygen in the lungs and releases it to tissues in a pattern that is indistinguishable from that seen in a control group of mice injected with their own blood.

In rats, ErythroMer effectively resuscitated animals in shock following acute loss of 40% of their blood volume.

So far, tests suggest ErythroMer has overcome barriers that halted the development of previous blood substitutes.

However, Dr Doctor noted that ErythroMer does have its weaknesses. The particles are cleared rapidly from the bloodstream (in 3 to 7 hours), and hemoglobin sourcing presents a challenge. The researchers are now exploring the possibility of using recombinant hemoglobin genetically engineered in yeast.

The team hopes to further optimize ErythroMer’s shell, extend circulation time, confirm the efficacy of ErythroMer in a larger animal model (rabbits), evaluate the impact of the product on the coagulation and immune systems, and scale up production.

If further testing goes well, the researchers estimate that ErythroMer could be ready for use by field medics and emergency responders within 10 to 12 years.

ErythroMer development has been supported by the Children’s Discovery Institute at Washington University and St. Louis Children’s Hospital, the Skandalaris Center at Washington University, and the BioSTL Fundamentals Program.

This research was funded by the National Institute of General Medical Sciences; the National Heart, Lung, and Blood Institute; the National Institute of Child Health and Human Development, the US Department of Defense; the American Heart Association; Doris Duke Foundation; and Children’s Discovery Institute.

SAN DIEGO—Researchers have developed artificial red blood cells (RBCs) that appear able to emulate functions of natural red blood cells (RBCs), at least in rodents.

The artificial RBCs, known as ErythroMer, are designed to be freeze-dried, stored at ambient temperatures, and reconstituted with water when needed.

If ErythroMer proves safe and effective in humans, it could represent an alternative to blood transfusions that might be useful in situations where donated blood is difficult to obtain or store.

“There are currently no simple, practical means to bring transfusion to most trauma victims outside of hospitals,” said Allan Doctor, MD, of Washington University in Saint Louis, Missouri.

“ErythroMer would be a blood substitute that a medic can carry in his or her pack and literally take it out, add water, and inject it.”

Dr Doctor presented details on ErythroMer at the 2016 ASH Annual Meeting (abstract 1027).

Design

“Due to significant advances in synthetic chemistry and nanomedicine, we’re now able to encapsulate biologics with programmable polymers to generate nanoparticles that can emulate normal cellular physiology,” Dr Doctor noted.

With ErythroMer, he and his colleagues encapsulated human hemoglobin, methylene blue, and 2,3-DPG in an amphiphilic polymer shell. The polymer and its payload components, through microfluidization, self-assemble into toroids that are about one-fiftieth the size of human RBCs.

ErythroMer is designed to be pH-responsive, so that, in areas of high pH, 2,3-DPG is sequestered in the inner surface of the particle shell and does not bind to hemoglobin. In areas of low pH, 2,3-DPG is released from the shell and binds to hemoglobin, facilitating oxygen offloading. The role of methylene blue is to inhibit auto-oxidation of hemoglobin.

The last step in synthesis of the particle is crosslinking of the surface, which neutralizes the surface charge, stabilizes the particle, and generates a selective diffusion barrier to nitric oxide. The particle can be lyophilized for extended storage and later reconstituted.

Testing

Tests showed that ErythroMer matches the oxygen binding feature of human RBCs within 10%, a level researchers say should be sufficient to stabilize a bleeding patient until a blood transfusion can be obtained.

Experiments in mice showed that ErythroMer captures oxygen in the lungs and releases it to tissues in a pattern that is indistinguishable from that seen in a control group of mice injected with their own blood.

In rats, ErythroMer effectively resuscitated animals in shock following acute loss of 40% of their blood volume.

So far, tests suggest ErythroMer has overcome barriers that halted the development of previous blood substitutes.

However, Dr Doctor noted that ErythroMer does have its weaknesses. The particles are cleared rapidly from the bloodstream (in 3 to 7 hours), and hemoglobin sourcing presents a challenge. The researchers are now exploring the possibility of using recombinant hemoglobin genetically engineered in yeast.

The team hopes to further optimize ErythroMer’s shell, extend circulation time, confirm the efficacy of ErythroMer in a larger animal model (rabbits), evaluate the impact of the product on the coagulation and immune systems, and scale up production.

If further testing goes well, the researchers estimate that ErythroMer could be ready for use by field medics and emergency responders within 10 to 12 years.

ErythroMer development has been supported by the Children’s Discovery Institute at Washington University and St. Louis Children’s Hospital, the Skandalaris Center at Washington University, and the BioSTL Fundamentals Program.

This research was funded by the National Institute of General Medical Sciences; the National Heart, Lung, and Blood Institute; the National Institute of Child Health and Human Development, the US Department of Defense; the American Heart Association; Doris Duke Foundation; and Children’s Discovery Institute.

Two groups of researchers have reported that an assay can accurately diagnose patients with variant Creutzfeldt-Jakob disease (vCJD), and this could allow for effective detection of prion contamination in donated blood.

The groups both said they were able to detect vCJD with 100% sensitivity and specificity.

One group even detected abnormal prion proteins in the blood of 2 subjects before the individuals exhibited any signs of vCJD.

The researchers said this work paves the way to a noninvasive, early diagnostic screen for vCJD and possibly other conditions involving protein misfolding.

Both studies were published in Science Translational Medicine.

“Our findings, which need to be confirmed in further studies, suggest that our method of detection could be useful for the noninvasive diagnosis of this disease in pre-symptomatic individuals,” said Claudio Soto, MD, author of one of the studies and a professor at the University of Texas Medical School in Houston.

“Early diagnosis would allow any potential therapy to be given before substantial brain damage has occurred. In the case of the blood supply, availability of a procedure to efficiently detect small quantities of the infectious agent would allow removal of blood units contaminated with prions so that new cases can be minimized substantially.”

For their study, Dr Soto and his colleagues used a protein misfolding cyclic amplification assay (PMCA) they developed, which mimics the prion replication process in vitro that occurs in prion disease.

The team used the assay to screen for abnormal prion proteins in blood from 14 individuals with vCJD and 153 control subjects.

In another study, Daisy Bougard, PhD, of Etablissement Français du Sang, INSERM, Université de Montpellier in France, and her colleagues tested a similar technique on blood samples from 18 individuals with vCJD and 238 without vCJD.

Dr Bougard’s group used the same PMCA as Dr Soto’s group. But Dr Bougard and her colleagues first captured prions from blood using plasminogen-coated beads.

In both studies, the PMCA diagnosed vCJD with 100% sensitivity and 100% specificity.

Dr Bougard and her colleagues were able to detect small amounts of prions in 2 blood donors more than a year before the onset of symptoms.

The researchers stressed that these results will need to be confirmed in a larger number of blood samples.

Two groups of researchers have reported that an assay can accurately diagnose patients with variant Creutzfeldt-Jakob disease (vCJD), and this could allow for effective detection of prion contamination in donated blood.

The groups both said they were able to detect vCJD with 100% sensitivity and specificity.

One group even detected abnormal prion proteins in the blood of 2 subjects before the individuals exhibited any signs of vCJD.

The researchers said this work paves the way to a noninvasive, early diagnostic screen for vCJD and possibly other conditions involving protein misfolding.

Both studies were published in Science Translational Medicine.

“Our findings, which need to be confirmed in further studies, suggest that our method of detection could be useful for the noninvasive diagnosis of this disease in pre-symptomatic individuals,” said Claudio Soto, MD, author of one of the studies and a professor at the University of Texas Medical School in Houston.

“Early diagnosis would allow any potential therapy to be given before substantial brain damage has occurred. In the case of the blood supply, availability of a procedure to efficiently detect small quantities of the infectious agent would allow removal of blood units contaminated with prions so that new cases can be minimized substantially.”

For their study, Dr Soto and his colleagues used a protein misfolding cyclic amplification assay (PMCA) they developed, which mimics the prion replication process in vitro that occurs in prion disease.

The team used the assay to screen for abnormal prion proteins in blood from 14 individuals with vCJD and 153 control subjects.

In another study, Daisy Bougard, PhD, of Etablissement Français du Sang, INSERM, Université de Montpellier in France, and her colleagues tested a similar technique on blood samples from 18 individuals with vCJD and 238 without vCJD.

Dr Bougard’s group used the same PMCA as Dr Soto’s group. But Dr Bougard and her colleagues first captured prions from blood using plasminogen-coated beads.

In both studies, the PMCA diagnosed vCJD with 100% sensitivity and 100% specificity.

Dr Bougard and her colleagues were able to detect small amounts of prions in 2 blood donors more than a year before the onset of symptoms.

The researchers stressed that these results will need to be confirmed in a larger number of blood samples.

Two groups of researchers have reported that an assay can accurately diagnose patients with variant Creutzfeldt-Jakob disease (vCJD), and this could allow for effective detection of prion contamination in donated blood.

The groups both said they were able to detect vCJD with 100% sensitivity and specificity.

One group even detected abnormal prion proteins in the blood of 2 subjects before the individuals exhibited any signs of vCJD.

The researchers said this work paves the way to a noninvasive, early diagnostic screen for vCJD and possibly other conditions involving protein misfolding.

Both studies were published in Science Translational Medicine.

“Our findings, which need to be confirmed in further studies, suggest that our method of detection could be useful for the noninvasive diagnosis of this disease in pre-symptomatic individuals,” said Claudio Soto, MD, author of one of the studies and a professor at the University of Texas Medical School in Houston.

“Early diagnosis would allow any potential therapy to be given before substantial brain damage has occurred. In the case of the blood supply, availability of a procedure to efficiently detect small quantities of the infectious agent would allow removal of blood units contaminated with prions so that new cases can be minimized substantially.”

For their study, Dr Soto and his colleagues used a protein misfolding cyclic amplification assay (PMCA) they developed, which mimics the prion replication process in vitro that occurs in prion disease.

The team used the assay to screen for abnormal prion proteins in blood from 14 individuals with vCJD and 153 control subjects.

In another study, Daisy Bougard, PhD, of Etablissement Français du Sang, INSERM, Université de Montpellier in France, and her colleagues tested a similar technique on blood samples from 18 individuals with vCJD and 238 without vCJD.

Dr Bougard’s group used the same PMCA as Dr Soto’s group. But Dr Bougard and her colleagues first captured prions from blood using plasminogen-coated beads.

In both studies, the PMCA diagnosed vCJD with 100% sensitivity and 100% specificity.

Dr Bougard and her colleagues were able to detect small amounts of prions in 2 blood donors more than a year before the onset of symptoms.

The researchers stressed that these results will need to be confirmed in a larger number of blood samples.

SAN DIEGO—Results of the phase 3 TRIST study support the use of a restrictive red blood cell (RBC) transfusion strategy in patients undergoing hematopoietic stem cell transplant (HSCT) to treat hematologic disorders.

The study suggests a restrictive strategy—in which patients receive 2 RBC units if their hemoglobin level is below 70 g/L—is non-inferior to a liberal strategy—in which patients receive 2 units if their hemoglobin level is below 90 g/L.

Clinical outcomes and health-related quality of life (HRQOL) were similar with both strategies.

Therefore, a restrictive strategy should be considered the standard of care in patients undergoing HSCT, according to study investigator Jason Tay, MD, of the University of Calgary/Tom Baker Cancer Center in Alberta, Canada.

Dr Tay presented results of the TRIST study at the 2016 ASH Annual Meeting (abstract 1032*).

He noted that recent AABB guidelines recommend using a restrictive RBC transfusion strategy in most circumstances. However, these recommendations do not apply to patients treated for hematologic or oncologic diseases who are at risk of bleeding, as there is a lack of randomized trials in such patients.

So Dr Tay and his colleagues decided to conduct a randomized, controlled trial comparing 2 RBC transfusion strategies in patients undergoing HSCT to treat hematologic disorders.

The study enrolled 300 patients who underwent HSCT between March 28, 2011, and February 3, 2016, at 4 Canadian centers.

The patients were randomized to 1 of 2 transfusion strategies from day 0 to day 100 post-HSCT:

• Restrictive strategy (n=149)—patients received 2 RBC units if their hemoglobin levels were below 70 g/L, to target a hemoglobin level of 70-90 g/L
• Liberal strategy (n=150)—patients received 2 RBC units if their hemoglobin levels were below 90 g/L, to target a hemoglobin level of 90-110 g/L.

The median age was 57.47 (range, 48.94-62.66) in the restrictive group and 56.04 (range, 48.27-62.24) in the liberal group. Most patients were male—65.10% and 62.67%, respectively.

Patients had acute leukemia (25.50% and 24.00%, respectively), chronic leukemia (6.71% and 6.00%), myeloproliferative disorders (2.68% and 2.00%), lymphoma (30.87% and 33.33%), myeloma (24.16% and 28.00%), and other disorders (10.07% and 6.67%, respectively).

About half of patients in each transfusion group received an autologous HSCT (49.66% and 50.00%, respectively), and about half received an allogeneic HSCT (50.34% and 50.00%, respectively).

Transfusion use

The total number of RBC units transfused was 407 in the restrictive group and 753 in the liberal group. The median number of RBC units transfused per patient was 2 (range, 0-2) and 4 (range, 2-6), respectively. The mean number was 2.73 and 5.02, respectively (P=0.0004).

The total number of RBC transfusion episodes was 234 in the restrictive group and 407 in the liberal group. The median number per patient was 1 (range, 0-2) and 2 (range, 1-3), respectively, and the mean was 1.57 and 2.70, respectively (P=0.002).

The median storage duration of the RBC units transfused was 17 days (range, 13-23) in the restrictive group and 20 days (range, 15-25) in the liberal group. The mean was 18.46 and 19.95, respectively (P=0.0003).

The between-group difference in the overall mean pre-transfusion hemoglobin per patient over the study period was 13.71 g/L.

The median number of platelet units transfused was 2 (range, 1-3) in the

restrictive group and 3 (range, 1-4) in the liberal group. The mean was 3.84 and 3.61, respectively (P=0.6930).

The median number of platelet transfusion episodes was 2 for both groups (range, 1-3 and

1-4, respectively). The mean was 3.84 in the restrictive group and 3.61 in the liberal group (P=0.77).

 

Adherence

In both groups, there were cases of non-adherence to the trigger hemoglobin value.

There were 49 non-adherent patients (32.89%) in the restrictive group—35 in whom an RBC transfusion occurred above the assigned trigger and 14 in whom a transfusion did not occur when the assigned trigger was reached.

There were 83 non-adherent patients (55.3%) in the liberal group—11 in whom an RBC transfusion occurred above the assigned trigger and 72 in whom a transfusion did not occur when the assigned trigger was reached.

Sixty-nine patients (46.31%) in the restrictive group and 21 (14%) in the liberal group never received an RBC transfusion.

Outcomes

The study’s primary endpoint was HRQOL, as measured by the FACT-BMT scale.

The total FACT-BMT score at day 100 was 116.3 (range, 98-129.2) in the restrictive group and 109.2 (range, 92.1-125.2) in the liberal group (P<0.0001 for non-inferiority).

Non-inferiority in HRQOL was shown for all other time points assessed as well—day 7 (P<0.001), day 14 (P<0.0001), day 28 (P<0.0001), and day 60 (P<0.0001). Total FACT-BMT scores at all time points were higher for patients in the restrictive group than the liberal one.

The study’s secondary endpoints included clinical outcomes and FACT-Anemia scores at several time points.

There was no significant difference in clinical outcomes between the restrictive and liberal transfusion groups.

There were 2 cases of transplant-related mortality in the restrictive group and 4 in the liberal group (P=0.42). And there were 4 cases of sinusoidal obstruction syndrome in both groups (P=0.98).

The median Bearman toxicity score at day 28 was 2 in both groups (range, 1-3 and 1-4, respectively). The mean was 2.5 in the restrictive group and 2.8 in the liberal group (P=0.33).

There was no significant between-group difference in WHO bleeding score at day 14 (P=0.13), day 28 (P=0.81), or day 100 (P=0.28).

There was no significant difference between the transfusion groups in the length of hospital stay for patients who received autologous HSCT (P=0.95) or allogeneic HSCT (P=0.23) or in the number of hospital readmissions for patients who received autologous HSCT (P=0.29) or allogeneic HSCT (P=0.81).

The total FACT-Anemia score was significantly higher in the restrictive transfusion group at day 7 (P=0.03) and day 60 (P=0.03) post-HSCT.

However, there was no significant between-group difference in FACT-Anemia score at 14 days (P=0.07), 28 days (P=0.51), or 100 days (P=0.14).

Dr Tay said these results suggest a restrictive RBC transfusion strategy is non-inferior to a liberal one in patients undergoing HSCT to treat a hematologic disorder.

“Moreover, a restrictive strategy is safe and results in less blood transfusions,” he said. “We’d like to suggest that a strategy of 70 g/L can be considered the standard of care in patients undergoing a stem cell transplantation.”

*Information presented at the meeting differs from the abstract.

SAN DIEGO—Results of the phase 3 TRIST study support the use of a restrictive red blood cell (RBC) transfusion strategy in patients undergoing hematopoietic stem cell transplant (HSCT) to treat hematologic disorders.

The study suggests a restrictive strategy—in which patients receive 2 RBC units if their hemoglobin level is below 70 g/L—is non-inferior to a liberal strategy—in which patients receive 2 units if their hemoglobin level is below 90 g/L.

Clinical outcomes and health-related quality of life (HRQOL) were similar with both strategies.

Therefore, a restrictive strategy should be considered the standard of care in patients undergoing HSCT, according to study investigator Jason Tay, MD, of the University of Calgary/Tom Baker Cancer Center in Alberta, Canada.

Dr Tay presented results of the TRIST study at the 2016 ASH Annual Meeting (abstract 1032*).

He noted that recent AABB guidelines recommend using a restrictive RBC transfusion strategy in most circumstances. However, these recommendations do not apply to patients treated for hematologic or oncologic diseases who are at risk of bleeding, as there is a lack of randomized trials in such patients.

So Dr Tay and his colleagues decided to conduct a randomized, controlled trial comparing 2 RBC transfusion strategies in patients undergoing HSCT to treat hematologic disorders.

The study enrolled 300 patients who underwent HSCT between March 28, 2011, and February 3, 2016, at 4 Canadian centers.

The patients were randomized to 1 of 2 transfusion strategies from day 0 to day 100 post-HSCT:

• Restrictive strategy (n=149)—patients received 2 RBC units if their hemoglobin levels were below 70 g/L, to target a hemoglobin level of 70-90 g/L
• Liberal strategy (n=150)—patients received 2 RBC units if their hemoglobin levels were below 90 g/L, to target a hemoglobin level of 90-110 g/L.

The median age was 57.47 (range, 48.94-62.66) in the restrictive group and 56.04 (range, 48.27-62.24) in the liberal group. Most patients were male—65.10% and 62.67%, respectively.

Patients had acute leukemia (25.50% and 24.00%, respectively), chronic leukemia (6.71% and 6.00%), myeloproliferative disorders (2.68% and 2.00%), lymphoma (30.87% and 33.33%), myeloma (24.16% and 28.00%), and other disorders (10.07% and 6.67%, respectively).

About half of patients in each transfusion group received an autologous HSCT (49.66% and 50.00%, respectively), and about half received an allogeneic HSCT (50.34% and 50.00%, respectively).

Transfusion use

The total number of RBC units transfused was 407 in the restrictive group and 753 in the liberal group. The median number of RBC units transfused per patient was 2 (range, 0-2) and 4 (range, 2-6), respectively. The mean number was 2.73 and 5.02, respectively (P=0.0004).

The total number of RBC transfusion episodes was 234 in the restrictive group and 407 in the liberal group. The median number per patient was 1 (range, 0-2) and 2 (range, 1-3), respectively, and the mean was 1.57 and 2.70, respectively (P=0.002).

The median storage duration of the RBC units transfused was 17 days (range, 13-23) in the restrictive group and 20 days (range, 15-25) in the liberal group. The mean was 18.46 and 19.95, respectively (P=0.0003).

The between-group difference in the overall mean pre-transfusion hemoglobin per patient over the study period was 13.71 g/L.

The median number of platelet units transfused was 2 (range, 1-3) in the

restrictive group and 3 (range, 1-4) in the liberal group. The mean was 3.84 and 3.61, respectively (P=0.6930).

The median number of platelet transfusion episodes was 2 for both groups (range, 1-3 and

1-4, respectively). The mean was 3.84 in the restrictive group and 3.61 in the liberal group (P=0.77).

 

Adherence

In both groups, there were cases of non-adherence to the trigger hemoglobin value.

There were 49 non-adherent patients (32.89%) in the restrictive group—35 in whom an RBC transfusion occurred above the assigned trigger and 14 in whom a transfusion did not occur when the assigned trigger was reached.

There were 83 non-adherent patients (55.3%) in the liberal group—11 in whom an RBC transfusion occurred above the assigned trigger and 72 in whom a transfusion did not occur when the assigned trigger was reached.

Sixty-nine patients (46.31%) in the restrictive group and 21 (14%) in the liberal group never received an RBC transfusion.

Outcomes

The study’s primary endpoint was HRQOL, as measured by the FACT-BMT scale.

The total FACT-BMT score at day 100 was 116.3 (range, 98-129.2) in the restrictive group and 109.2 (range, 92.1-125.2) in the liberal group (P<0.0001 for non-inferiority).

Non-inferiority in HRQOL was shown for all other time points assessed as well—day 7 (P<0.001), day 14 (P<0.0001), day 28 (P<0.0001), and day 60 (P<0.0001). Total FACT-BMT scores at all time points were higher for patients in the restrictive group than the liberal one.

The study’s secondary endpoints included clinical outcomes and FACT-Anemia scores at several time points.

There was no significant difference in clinical outcomes between the restrictive and liberal transfusion groups.

There were 2 cases of transplant-related mortality in the restrictive group and 4 in the liberal group (P=0.42). And there were 4 cases of sinusoidal obstruction syndrome in both groups (P=0.98).

The median Bearman toxicity score at day 28 was 2 in both groups (range, 1-3 and 1-4, respectively). The mean was 2.5 in the restrictive group and 2.8 in the liberal group (P=0.33).

There was no significant between-group difference in WHO bleeding score at day 14 (P=0.13), day 28 (P=0.81), or day 100 (P=0.28).

There was no significant difference between the transfusion groups in the length of hospital stay for patients who received autologous HSCT (P=0.95) or allogeneic HSCT (P=0.23) or in the number of hospital readmissions for patients who received autologous HSCT (P=0.29) or allogeneic HSCT (P=0.81).

The total FACT-Anemia score was significantly higher in the restrictive transfusion group at day 7 (P=0.03) and day 60 (P=0.03) post-HSCT.

However, there was no significant between-group difference in FACT-Anemia score at 14 days (P=0.07), 28 days (P=0.51), or 100 days (P=0.14).

Dr Tay said these results suggest a restrictive RBC transfusion strategy is non-inferior to a liberal one in patients undergoing HSCT to treat a hematologic disorder.

“Moreover, a restrictive strategy is safe and results in less blood transfusions,” he said. “We’d like to suggest that a strategy of 70 g/L can be considered the standard of care in patients undergoing a stem cell transplantation.”

*Information presented at the meeting differs from the abstract.

SAN DIEGO—Results of the phase 3 TRIST study support the use of a restrictive red blood cell (RBC) transfusion strategy in patients undergoing hematopoietic stem cell transplant (HSCT) to treat hematologic disorders.

The study suggests a restrictive strategy—in which patients receive 2 RBC units if their hemoglobin level is below 70 g/L—is non-inferior to a liberal strategy—in which patients receive 2 units if their hemoglobin level is below 90 g/L.

Clinical outcomes and health-related quality of life (HRQOL) were similar with both strategies.

Therefore, a restrictive strategy should be considered the standard of care in patients undergoing HSCT, according to study investigator Jason Tay, MD, of the University of Calgary/Tom Baker Cancer Center in Alberta, Canada.

Dr Tay presented results of the TRIST study at the 2016 ASH Annual Meeting (abstract 1032*).

He noted that recent AABB guidelines recommend using a restrictive RBC transfusion strategy in most circumstances. However, these recommendations do not apply to patients treated for hematologic or oncologic diseases who are at risk of bleeding, as there is a lack of randomized trials in such patients.

So Dr Tay and his colleagues decided to conduct a randomized, controlled trial comparing 2 RBC transfusion strategies in patients undergoing HSCT to treat hematologic disorders.

The study enrolled 300 patients who underwent HSCT between March 28, 2011, and February 3, 2016, at 4 Canadian centers.

The patients were randomized to 1 of 2 transfusion strategies from day 0 to day 100 post-HSCT:

• Restrictive strategy (n=149)—patients received 2 RBC units if their hemoglobin levels were below 70 g/L, to target a hemoglobin level of 70-90 g/L
• Liberal strategy (n=150)—patients received 2 RBC units if their hemoglobin levels were below 90 g/L, to target a hemoglobin level of 90-110 g/L.

The median age was 57.47 (range, 48.94-62.66) in the restrictive group and 56.04 (range, 48.27-62.24) in the liberal group. Most patients were male—65.10% and 62.67%, respectively.

Patients had acute leukemia (25.50% and 24.00%, respectively), chronic leukemia (6.71% and 6.00%), myeloproliferative disorders (2.68% and 2.00%), lymphoma (30.87% and 33.33%), myeloma (24.16% and 28.00%), and other disorders (10.07% and 6.67%, respectively).

About half of patients in each transfusion group received an autologous HSCT (49.66% and 50.00%, respectively), and about half received an allogeneic HSCT (50.34% and 50.00%, respectively).

Transfusion use

The total number of RBC units transfused was 407 in the restrictive group and 753 in the liberal group. The median number of RBC units transfused per patient was 2 (range, 0-2) and 4 (range, 2-6), respectively. The mean number was 2.73 and 5.02, respectively (P=0.0004).

The total number of RBC transfusion episodes was 234 in the restrictive group and 407 in the liberal group. The median number per patient was 1 (range, 0-2) and 2 (range, 1-3), respectively, and the mean was 1.57 and 2.70, respectively (P=0.002).

The median storage duration of the RBC units transfused was 17 days (range, 13-23) in the restrictive group and 20 days (range, 15-25) in the liberal group. The mean was 18.46 and 19.95, respectively (P=0.0003).

The between-group difference in the overall mean pre-transfusion hemoglobin per patient over the study period was 13.71 g/L.

The median number of platelet units transfused was 2 (range, 1-3) in the

restrictive group and 3 (range, 1-4) in the liberal group. The mean was 3.84 and 3.61, respectively (P=0.6930).

The median number of platelet transfusion episodes was 2 for both groups (range, 1-3 and

1-4, respectively). The mean was 3.84 in the restrictive group and 3.61 in the liberal group (P=0.77).

 

Adherence

In both groups, there were cases of non-adherence to the trigger hemoglobin value.

There were 49 non-adherent patients (32.89%) in the restrictive group—35 in whom an RBC transfusion occurred above the assigned trigger and 14 in whom a transfusion did not occur when the assigned trigger was reached.

There were 83 non-adherent patients (55.3%) in the liberal group—11 in whom an RBC transfusion occurred above the assigned trigger and 72 in whom a transfusion did not occur when the assigned trigger was reached.

Sixty-nine patients (46.31%) in the restrictive group and 21 (14%) in the liberal group never received an RBC transfusion.

Outcomes

The study’s primary endpoint was HRQOL, as measured by the FACT-BMT scale.

The total FACT-BMT score at day 100 was 116.3 (range, 98-129.2) in the restrictive group and 109.2 (range, 92.1-125.2) in the liberal group (P<0.0001 for non-inferiority).

Non-inferiority in HRQOL was shown for all other time points assessed as well—day 7 (P<0.001), day 14 (P<0.0001), day 28 (P<0.0001), and day 60 (P<0.0001). Total FACT-BMT scores at all time points were higher for patients in the restrictive group than the liberal one.

The study’s secondary endpoints included clinical outcomes and FACT-Anemia scores at several time points.

There was no significant difference in clinical outcomes between the restrictive and liberal transfusion groups.

There were 2 cases of transplant-related mortality in the restrictive group and 4 in the liberal group (P=0.42). And there were 4 cases of sinusoidal obstruction syndrome in both groups (P=0.98).

The median Bearman toxicity score at day 28 was 2 in both groups (range, 1-3 and 1-4, respectively). The mean was 2.5 in the restrictive group and 2.8 in the liberal group (P=0.33).

There was no significant between-group difference in WHO bleeding score at day 14 (P=0.13), day 28 (P=0.81), or day 100 (P=0.28).

There was no significant difference between the transfusion groups in the length of hospital stay for patients who received autologous HSCT (P=0.95) or allogeneic HSCT (P=0.23) or in the number of hospital readmissions for patients who received autologous HSCT (P=0.29) or allogeneic HSCT (P=0.81).

The total FACT-Anemia score was significantly higher in the restrictive transfusion group at day 7 (P=0.03) and day 60 (P=0.03) post-HSCT.

However, there was no significant between-group difference in FACT-Anemia score at 14 days (P=0.07), 28 days (P=0.51), or 100 days (P=0.14).

Dr Tay said these results suggest a restrictive RBC transfusion strategy is non-inferior to a liberal one in patients undergoing HSCT to treat a hematologic disorder.

“Moreover, a restrictive strategy is safe and results in less blood transfusions,” he said. “We’d like to suggest that a strategy of 70 g/L can be considered the standard of care in patients undergoing a stem cell transplantation.”

*Information presented at the meeting differs from the abstract.

A proof-of-concept study suggests that large bags of blood products can maintain temperature and cellular integrity when transported by drones.

Researchers say these findings, published in Transfusion, add to evidence that remotely piloted drones are an effective, safe, and timely way to quickly get blood products to remote accident or natural catastrophe sites, or other time-sensitive destinations.

“For rural areas that lack access to nearby clinics, or that may lack the infrastructure for collecting blood products or transporting them on their own, drones can provide that access,” said study author Timothy Amukele, MD, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.

Drones also can help in urban centers to improve distribution of blood products and the quality of care, he added.

Dr Amukele and his colleagues previously studied the impact of drone transportation on the chemical, hematological, and microbial makeup of drone-flown blood samples and found that none were negatively affected.

Study design, methods

In the new study, the team examined the effects of drone transportation on larger amounts of blood products used for transfusion, which have significantly more complex handling, transport, and storage requirements compared to blood samples for laboratory testing.

The researchers purchased 6 units of red blood cells (RBCs), 6 units of platelets, and 6 units of unthawed plasma from the American Red Cross. They then packed the units into a 5-quart cooler, 2 to 3 units at a time, in keeping with weight restrictions for the transport drone.

The cooler was then attached to a commercial S900-model drone. This particular drone model comes equipped with a camera mount, which the team removed and replaced with the cooler.

For each test, the drone was flown by remote control a distance of approximately 13 to 20 kilometers (8 to 12 miles) while 100 meters (328 feet) above ground. This flight took up to 26.5 minutes.

The researchers designed the test to maintain temperature for the RBCs, platelets, and plasma units. They used wet ice, pre-calibrated thermal packs, and dry ice for each type of blood product, respectively.

Temperature monitoring was constant, keeping with transport and storage requirements for blood components.

The team conducted the tests in an unpopulated area, and a certified, ground-based pilot flew the drone.

Following flight, all units were transported to The Johns Hopkins Hospital and compared to blood products that had not taken a drone trip.

Results

Dr Amukele and his colleagues checked the RBCs for signs of hemolysis. They checked the platelets for changes in pH, the number of platelets, and mean platelet volume. And they checked the plasma units for evidence of air bubbles, which would indicate thawing.

The researchers found no evidence of hemolysis in the control RBCs or the RBCs that had taken the drone flight.

There was no significant difference in pH, platelet counts, or mean platelet volume between control and drone-flown platelets.

And there was no apparent change in the size or shape of air bubbles in the plasma units before and after drone flight.

However, the researchers did find that, for all flown units, there was a decrease in temperature of between 1.5°C and 4°C during the course of the flight. They said the cause of this decrease was probably the ambient temperature in the case of the platelet units, the wet ice in the case of the RBCs, and the dry ice in the case of the plasma.

 

The team also found an up to 2°C difference between individual flights for both the RBCs and the plasma units. They said this difference is likely due to the differences in the amounts of wet and dry ice placed in the cooler.

The researchers are planning further and larger studies in the US and overseas, and they hope to test methods of active cooling, such as programming a cooler to maintain a specific temperature.

“My vision is that, in the future, when a first responder arrives to the scene of an accident, he or she can test the victim’s blood type right on the spot and send for a drone to bring the correct blood product,” Dr Amukele said.

Funding for this study was provided by Peter Kovler of the Blum-Kovler Foundation.

A proof-of-concept study suggests that large bags of blood products can maintain temperature and cellular integrity when transported by drones.

Researchers say these findings, published in Transfusion, add to evidence that remotely piloted drones are an effective, safe, and timely way to quickly get blood products to remote accident or natural catastrophe sites, or other time-sensitive destinations.

“For rural areas that lack access to nearby clinics, or that may lack the infrastructure for collecting blood products or transporting them on their own, drones can provide that access,” said study author Timothy Amukele, MD, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.

Drones also can help in urban centers to improve distribution of blood products and the quality of care, he added.

Dr Amukele and his colleagues previously studied the impact of drone transportation on the chemical, hematological, and microbial makeup of drone-flown blood samples and found that none were negatively affected.

Study design, methods

In the new study, the team examined the effects of drone transportation on larger amounts of blood products used for transfusion, which have significantly more complex handling, transport, and storage requirements compared to blood samples for laboratory testing.

The researchers purchased 6 units of red blood cells (RBCs), 6 units of platelets, and 6 units of unthawed plasma from the American Red Cross. They then packed the units into a 5-quart cooler, 2 to 3 units at a time, in keeping with weight restrictions for the transport drone.

The cooler was then attached to a commercial S900-model drone. This particular drone model comes equipped with a camera mount, which the team removed and replaced with the cooler.

For each test, the drone was flown by remote control a distance of approximately 13 to 20 kilometers (8 to 12 miles) while 100 meters (328 feet) above ground. This flight took up to 26.5 minutes.

The researchers designed the test to maintain temperature for the RBCs, platelets, and plasma units. They used wet ice, pre-calibrated thermal packs, and dry ice for each type of blood product, respectively.

Temperature monitoring was constant, keeping with transport and storage requirements for blood components.

The team conducted the tests in an unpopulated area, and a certified, ground-based pilot flew the drone.

Following flight, all units were transported to The Johns Hopkins Hospital and compared to blood products that had not taken a drone trip.

Results

Dr Amukele and his colleagues checked the RBCs for signs of hemolysis. They checked the platelets for changes in pH, the number of platelets, and mean platelet volume. And they checked the plasma units for evidence of air bubbles, which would indicate thawing.

The researchers found no evidence of hemolysis in the control RBCs or the RBCs that had taken the drone flight.

There was no significant difference in pH, platelet counts, or mean platelet volume between control and drone-flown platelets.

And there was no apparent change in the size or shape of air bubbles in the plasma units before and after drone flight.

However, the researchers did find that, for all flown units, there was a decrease in temperature of between 1.5°C and 4°C during the course of the flight. They said the cause of this decrease was probably the ambient temperature in the case of the platelet units, the wet ice in the case of the RBCs, and the dry ice in the case of the plasma.

 

The team also found an up to 2°C difference between individual flights for both the RBCs and the plasma units. They said this difference is likely due to the differences in the amounts of wet and dry ice placed in the cooler.

The researchers are planning further and larger studies in the US and overseas, and they hope to test methods of active cooling, such as programming a cooler to maintain a specific temperature.

“My vision is that, in the future, when a first responder arrives to the scene of an accident, he or she can test the victim’s blood type right on the spot and send for a drone to bring the correct blood product,” Dr Amukele said.

Funding for this study was provided by Peter Kovler of the Blum-Kovler Foundation.

A proof-of-concept study suggests that large bags of blood products can maintain temperature and cellular integrity when transported by drones.

Researchers say these findings, published in Transfusion, add to evidence that remotely piloted drones are an effective, safe, and timely way to quickly get blood products to remote accident or natural catastrophe sites, or other time-sensitive destinations.

“For rural areas that lack access to nearby clinics, or that may lack the infrastructure for collecting blood products or transporting them on their own, drones can provide that access,” said study author Timothy Amukele, MD, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.

Drones also can help in urban centers to improve distribution of blood products and the quality of care, he added.

Dr Amukele and his colleagues previously studied the impact of drone transportation on the chemical, hematological, and microbial makeup of drone-flown blood samples and found that none were negatively affected.

Study design, methods

In the new study, the team examined the effects of drone transportation on larger amounts of blood products used for transfusion, which have significantly more complex handling, transport, and storage requirements compared to blood samples for laboratory testing.

The researchers purchased 6 units of red blood cells (RBCs), 6 units of platelets, and 6 units of unthawed plasma from the American Red Cross. They then packed the units into a 5-quart cooler, 2 to 3 units at a time, in keeping with weight restrictions for the transport drone.

The cooler was then attached to a commercial S900-model drone. This particular drone model comes equipped with a camera mount, which the team removed and replaced with the cooler.

For each test, the drone was flown by remote control a distance of approximately 13 to 20 kilometers (8 to 12 miles) while 100 meters (328 feet) above ground. This flight took up to 26.5 minutes.

The researchers designed the test to maintain temperature for the RBCs, platelets, and plasma units. They used wet ice, pre-calibrated thermal packs, and dry ice for each type of blood product, respectively.

Temperature monitoring was constant, keeping with transport and storage requirements for blood components.

The team conducted the tests in an unpopulated area, and a certified, ground-based pilot flew the drone.

Following flight, all units were transported to The Johns Hopkins Hospital and compared to blood products that had not taken a drone trip.

Results

Dr Amukele and his colleagues checked the RBCs for signs of hemolysis. They checked the platelets for changes in pH, the number of platelets, and mean platelet volume. And they checked the plasma units for evidence of air bubbles, which would indicate thawing.

The researchers found no evidence of hemolysis in the control RBCs or the RBCs that had taken the drone flight.

There was no significant difference in pH, platelet counts, or mean platelet volume between control and drone-flown platelets.

And there was no apparent change in the size or shape of air bubbles in the plasma units before and after drone flight.

However, the researchers did find that, for all flown units, there was a decrease in temperature of between 1.5°C and 4°C during the course of the flight. They said the cause of this decrease was probably the ambient temperature in the case of the platelet units, the wet ice in the case of the RBCs, and the dry ice in the case of the plasma.

 

The team also found an up to 2°C difference between individual flights for both the RBCs and the plasma units. They said this difference is likely due to the differences in the amounts of wet and dry ice placed in the cooler.

The researchers are planning further and larger studies in the US and overseas, and they hope to test methods of active cooling, such as programming a cooler to maintain a specific temperature.

“My vision is that, in the future, when a first responder arrives to the scene of an accident, he or she can test the victim’s blood type right on the spot and send for a drone to bring the correct blood product,” Dr Amukele said.

Funding for this study was provided by Peter Kovler of the Blum-Kovler Foundation.

There is no association between sex-discordant blood transfusions and the risk of death after cardiac surgery, according to research published in Circulation.

Two previous studies suggested that patients who received red blood cells (RBCs) from a donor of the opposite sex had an increased risk of death after cardiac surgery.

However, the current study showed no significant difference between same-sex and opposite-sex donor-recipient pairs.

The researchers said the reason for the difference between the new and older studies is that, in the new study, the team “carefully adjusted” for the number of transfusions performed and allowed for the effect of RBC transfusions on mortality to differ between men and women.

“The consequences of the findings from [the earlier studies], if proved true, would have been immense and necessitated radical changes to how blood transfusions are managed around the world,” said Martin Holzmann, MD, PhD, of Karolinska Institutet in Stockholm, Sweden.

“Our results clearly show that there is no real connection between sex-discordant blood transfusions and the risk of death.”

Therefore, Dr Holzmann and his colleagues believe there is no need to consider donor sex when allocating RBC units for transfusion.

To come to this conclusion, the researchers analyzed data on 45,090 patients who underwent cardiac surgery and received at least 1 RBC transfusion.

All patients were adults who had undergone isolated coronary artery bypass grafting, isolated valve repair/replacement surgery, or a combination of these procedures between 1997 and 2012.

The researchers estimated the relative hazard of death in relation to exposure to sex-discordant transfusions, adjusting their analyses for potential confounding factors, such as patient sex, age, blood group, and number of transfusions.

Results

The researchers found that women were more likely to receive sex-discordant transfusions than same-sex transfusions—45.3% and 19.8%, respectively. And patients who received sex-discordant transfusions tended to receive more transfusions—a mean of 4.2 vs 2.0 for same-sex transfusions.

However, there were no other significant differences between the sex-discordant and same-sex groups.

The researchers noted that, during the 30-day follow-up period, there were more deaths among patients who received sex-discordant transfusions than those who did not—1701 (4.9%) and 205 (1.9%), respectively.

However, when the team adjusted for potential confounding factors, the relative risk of death was similar for patients who received at least 1 unit of sex-discordant blood and those who did not. The hazard ratio was 0.97 at 30 days of follow-up, 0.97 at the 2-year mark, and 0.98 at 10 years of follow-up.

The risk of death did increase as the number of sex-discordant units transfused increased. However, the increase was not statistically significant.

There is no association between sex-discordant blood transfusions and the risk of death after cardiac surgery, according to research published in Circulation.

Two previous studies suggested that patients who received red blood cells (RBCs) from a donor of the opposite sex had an increased risk of death after cardiac surgery.

However, the current study showed no significant difference between same-sex and opposite-sex donor-recipient pairs.

The researchers said the reason for the difference between the new and older studies is that, in the new study, the team “carefully adjusted” for the number of transfusions performed and allowed for the effect of RBC transfusions on mortality to differ between men and women.

“The consequences of the findings from [the earlier studies], if proved true, would have been immense and necessitated radical changes to how blood transfusions are managed around the world,” said Martin Holzmann, MD, PhD, of Karolinska Institutet in Stockholm, Sweden.

“Our results clearly show that there is no real connection between sex-discordant blood transfusions and the risk of death.”

Therefore, Dr Holzmann and his colleagues believe there is no need to consider donor sex when allocating RBC units for transfusion.

To come to this conclusion, the researchers analyzed data on 45,090 patients who underwent cardiac surgery and received at least 1 RBC transfusion.

All patients were adults who had undergone isolated coronary artery bypass grafting, isolated valve repair/replacement surgery, or a combination of these procedures between 1997 and 2012.

The researchers estimated the relative hazard of death in relation to exposure to sex-discordant transfusions, adjusting their analyses for potential confounding factors, such as patient sex, age, blood group, and number of transfusions.

Results

The researchers found that women were more likely to receive sex-discordant transfusions than same-sex transfusions—45.3% and 19.8%, respectively. And patients who received sex-discordant transfusions tended to receive more transfusions—a mean of 4.2 vs 2.0 for same-sex transfusions.

However, there were no other significant differences between the sex-discordant and same-sex groups.

The researchers noted that, during the 30-day follow-up period, there were more deaths among patients who received sex-discordant transfusions than those who did not—1701 (4.9%) and 205 (1.9%), respectively.

However, when the team adjusted for potential confounding factors, the relative risk of death was similar for patients who received at least 1 unit of sex-discordant blood and those who did not. The hazard ratio was 0.97 at 30 days of follow-up, 0.97 at the 2-year mark, and 0.98 at 10 years of follow-up.

The risk of death did increase as the number of sex-discordant units transfused increased. However, the increase was not statistically significant.

There is no association between sex-discordant blood transfusions and the risk of death after cardiac surgery, according to research published in Circulation.

Two previous studies suggested that patients who received red blood cells (RBCs) from a donor of the opposite sex had an increased risk of death after cardiac surgery.

However, the current study showed no significant difference between same-sex and opposite-sex donor-recipient pairs.

The researchers said the reason for the difference between the new and older studies is that, in the new study, the team “carefully adjusted” for the number of transfusions performed and allowed for the effect of RBC transfusions on mortality to differ between men and women.

“The consequences of the findings from [the earlier studies], if proved true, would have been immense and necessitated radical changes to how blood transfusions are managed around the world,” said Martin Holzmann, MD, PhD, of Karolinska Institutet in Stockholm, Sweden.

“Our results clearly show that there is no real connection between sex-discordant blood transfusions and the risk of death.”

Therefore, Dr Holzmann and his colleagues believe there is no need to consider donor sex when allocating RBC units for transfusion.

To come to this conclusion, the researchers analyzed data on 45,090 patients who underwent cardiac surgery and received at least 1 RBC transfusion.

All patients were adults who had undergone isolated coronary artery bypass grafting, isolated valve repair/replacement surgery, or a combination of these procedures between 1997 and 2012.

The researchers estimated the relative hazard of death in relation to exposure to sex-discordant transfusions, adjusting their analyses for potential confounding factors, such as patient sex, age, blood group, and number of transfusions.

Results

The researchers found that women were more likely to receive sex-discordant transfusions than same-sex transfusions—45.3% and 19.8%, respectively. And patients who received sex-discordant transfusions tended to receive more transfusions—a mean of 4.2 vs 2.0 for same-sex transfusions.

However, there were no other significant differences between the sex-discordant and same-sex groups.

The researchers noted that, during the 30-day follow-up period, there were more deaths among patients who received sex-discordant transfusions than those who did not—1701 (4.9%) and 205 (1.9%), respectively.

However, when the team adjusted for potential confounding factors, the relative risk of death was similar for patients who received at least 1 unit of sex-discordant blood and those who did not. The hazard ratio was 0.97 at 30 days of follow-up, 0.97 at the 2-year mark, and 0.98 at 10 years of follow-up.

The risk of death did increase as the number of sex-discordant units transfused increased. However, the increase was not statistically significant.