Blood Banking

Attendees at the 21st

Congress of the European

Hematology Association

COPENHAGEN—Results of the phase 3 PATCH trial suggest that platelet transfusions are not beneficial and can actually cause harm in patients with intracerebral hemorrhage (ICH) associated with antiplatelet therapy.

The study showed that the odds of death or dependence at 3 months were significantly higher among patients who received a platelet transfusion plus standard care than among patients who received standard care alone.

Patients who received a platelet transfusion also had a higher incidence of severe adverse events (SAEs) during hospital admission.

“PATCH shows that platelet transfusion seems harmful for patients with antiplatelet-associated ICH,” said study investigator Maria Koopman, PhD, of Sanquin Bloodbank in Amsterdam, The Netherlands.

“Pending further evidence, we think that platelet transfusions should not be used in this patient group.”

Dr Koopman presented results of the PATCH trial at the 21st Congress of the European Hematology Association (abstract LB2234). The study was also recently published in The Lancet.

Dr Koopman noted that, worldwide, there are 2 million cases of ICH each year, and more than 25% of these patients are taking antiplatelet therapy at ICH onset.

She and her colleagues theorized that because antiplatelet therapy can lead to hematoma growth and poor outcomes, platelet transfusions might modify the effect of antiplatelet therapy and improve patient outcomes.

To test this theory, the team studied ICH patients treated at 60 hospitals in The Netherlands, Scotland, and France.

Patients and treatment

The study included patients with spontaneous supratentorial ICH who were 18 years of age or older, had been using antiplatelet therapy for at least 7 days preceding ICH, and had a Glasgow Coma Scale score of 8 or higher.

The patients were randomized 1:1 to receive either standard care alone or standard care plus a platelet transfusion within 6 hours of the start of symptoms and within 90 minutes of diagnostic brain imaging.

In all, 190 patients were randomized—97 to the transfusion arm and 93 to the standard care arm. Ultimately, 93 patients actually received a platelet transfusion, and 91 received standard care alone.

Patient characteristics were generally balanced between the treatment arms. The mean age was 74.2 in the transfusion arm and 73.5 in the standard care arm. Median scores on the Glasgow Coma Scale were 14 (range, 13-15) and 15 (range, 13-15), respectively.

Comorbidities included cerebral infarction (38.4% and 40%, respectively), hypertension (72.3% and 72.8%, respectively), diabetes (15.5% and 18.9%, respectively), myocardial infarction (23.6% and 24.4%, respectively), and peripheral artery disease (16.5% and 4.4%, respectively).

Antiplatelet therapy consisted of a cyclooxygenase (COX) inhibitor (73.2% and 83.9%, respectively), a COX inhibitor plus dipyridamole (18.6% and 14%, respectively), an adenosine diphosphate (ADP) receptor inhibitor (4.1% and 1.1%, respectively), and an ADP inhibitor plus a COX inhibitor (3.1% and 1.1%, respectively).

Efficacy

The study’s primary outcome was a shift toward death or dependence, rated on the modified Rankin Scale (mRS), at 3 months after ICH, adjusted for hospital, antiplatelet therapy, and ICH score. The primary analysis was done in the intention-to-treat population (n=97 in the transfusion arm and 93 in the standard care arm).

The investigators found the odds of death or dependence at 3 months were higher in the platelet transfusion arm than the standard care arm. The adjusted common odds ratio (OR) was 2.05 (95% CI 1.18-3.56; P=0.0114).

The study’s secondary endpoints were survival at 3 months, poor outcome (dichotomous mRS 4-6 or 3-6) at 3 months, and hematoma growth on imaging within 24 hours.

The survival rate was lower in the transfusion arm than the standard care arm, although the difference was not statistically significant—68% and 77.4%, respectively (OR=0.62; 95% CI, 0.33-1.19; P=0.15).

Poor outcome was more likely in the transfusion arm than the standard care arm, with 72.2% and 55.9% of patients, respectively, having an mRS score of 4-6 (OR=2.04; 95% CI, 1.12-3.74; P=0.0195) and 88.7% and 81.7%, respectively, having an mRS score of 3-6 (OR=1.75; 95% CI, 0.77-3.97; P=0.18).

And there was no significant difference between the arms when it came to hematoma growth, with a median of 2.01 mL (interquartile range, 0.32-9.34) in the transfusion arm and 1.16 mL (interquartile range, 0.03-4.42) in the standard care arm (P=0.81).

Safety

Safety endpoints included thromboembolic events, transfusion reactions, and SAEs during hospital admission. The safety analysis was done in the intention-to-treat population (n=97 in the transfusion arm and 93 in the standard care arm) and the as-treated population (n=93 and 91, respectively).

In the as-treated population, the incidence of SAEs was 42% in the transfusion arm and 29% in the standard care arm (OR=1.74; 95% CI, 0.96-3.17). The incidence of any fatal SAE was 24% and 17%, respectively (OR=1.58; 95% CI, 1.77-3.22).

The incidence of SAEs due to ICH was 25% and 14%, respectively (OR=2.13; 95% CI, 1.01-4.50). The incidence of SAEs due to thromboembolism was 4% and 1%, respectively (OR=4.13; 95% CI, 0.45-37.67). And there was 1 SAE due to transfusion (OR=3.03; 95% CI, 0.12-75.37).

Attendees at the 21st

Congress of the European

Hematology Association

COPENHAGEN—Results of the phase 3 PATCH trial suggest that platelet transfusions are not beneficial and can actually cause harm in patients with intracerebral hemorrhage (ICH) associated with antiplatelet therapy.

The study showed that the odds of death or dependence at 3 months were significantly higher among patients who received a platelet transfusion plus standard care than among patients who received standard care alone.

Patients who received a platelet transfusion also had a higher incidence of severe adverse events (SAEs) during hospital admission.

“PATCH shows that platelet transfusion seems harmful for patients with antiplatelet-associated ICH,” said study investigator Maria Koopman, PhD, of Sanquin Bloodbank in Amsterdam, The Netherlands.

“Pending further evidence, we think that platelet transfusions should not be used in this patient group.”

Dr Koopman presented results of the PATCH trial at the 21st Congress of the European Hematology Association (abstract LB2234). The study was also recently published in The Lancet.

Dr Koopman noted that, worldwide, there are 2 million cases of ICH each year, and more than 25% of these patients are taking antiplatelet therapy at ICH onset.

She and her colleagues theorized that because antiplatelet therapy can lead to hematoma growth and poor outcomes, platelet transfusions might modify the effect of antiplatelet therapy and improve patient outcomes.

To test this theory, the team studied ICH patients treated at 60 hospitals in The Netherlands, Scotland, and France.

Patients and treatment

The study included patients with spontaneous supratentorial ICH who were 18 years of age or older, had been using antiplatelet therapy for at least 7 days preceding ICH, and had a Glasgow Coma Scale score of 8 or higher.

The patients were randomized 1:1 to receive either standard care alone or standard care plus a platelet transfusion within 6 hours of the start of symptoms and within 90 minutes of diagnostic brain imaging.

In all, 190 patients were randomized—97 to the transfusion arm and 93 to the standard care arm. Ultimately, 93 patients actually received a platelet transfusion, and 91 received standard care alone.

Patient characteristics were generally balanced between the treatment arms. The mean age was 74.2 in the transfusion arm and 73.5 in the standard care arm. Median scores on the Glasgow Coma Scale were 14 (range, 13-15) and 15 (range, 13-15), respectively.

Comorbidities included cerebral infarction (38.4% and 40%, respectively), hypertension (72.3% and 72.8%, respectively), diabetes (15.5% and 18.9%, respectively), myocardial infarction (23.6% and 24.4%, respectively), and peripheral artery disease (16.5% and 4.4%, respectively).

Antiplatelet therapy consisted of a cyclooxygenase (COX) inhibitor (73.2% and 83.9%, respectively), a COX inhibitor plus dipyridamole (18.6% and 14%, respectively), an adenosine diphosphate (ADP) receptor inhibitor (4.1% and 1.1%, respectively), and an ADP inhibitor plus a COX inhibitor (3.1% and 1.1%, respectively).

Efficacy

The study’s primary outcome was a shift toward death or dependence, rated on the modified Rankin Scale (mRS), at 3 months after ICH, adjusted for hospital, antiplatelet therapy, and ICH score. The primary analysis was done in the intention-to-treat population (n=97 in the transfusion arm and 93 in the standard care arm).

The investigators found the odds of death or dependence at 3 months were higher in the platelet transfusion arm than the standard care arm. The adjusted common odds ratio (OR) was 2.05 (95% CI 1.18-3.56; P=0.0114).

The study’s secondary endpoints were survival at 3 months, poor outcome (dichotomous mRS 4-6 or 3-6) at 3 months, and hematoma growth on imaging within 24 hours.

The survival rate was lower in the transfusion arm than the standard care arm, although the difference was not statistically significant—68% and 77.4%, respectively (OR=0.62; 95% CI, 0.33-1.19; P=0.15).

Poor outcome was more likely in the transfusion arm than the standard care arm, with 72.2% and 55.9% of patients, respectively, having an mRS score of 4-6 (OR=2.04; 95% CI, 1.12-3.74; P=0.0195) and 88.7% and 81.7%, respectively, having an mRS score of 3-6 (OR=1.75; 95% CI, 0.77-3.97; P=0.18).

And there was no significant difference between the arms when it came to hematoma growth, with a median of 2.01 mL (interquartile range, 0.32-9.34) in the transfusion arm and 1.16 mL (interquartile range, 0.03-4.42) in the standard care arm (P=0.81).

Safety

Safety endpoints included thromboembolic events, transfusion reactions, and SAEs during hospital admission. The safety analysis was done in the intention-to-treat population (n=97 in the transfusion arm and 93 in the standard care arm) and the as-treated population (n=93 and 91, respectively).

In the as-treated population, the incidence of SAEs was 42% in the transfusion arm and 29% in the standard care arm (OR=1.74; 95% CI, 0.96-3.17). The incidence of any fatal SAE was 24% and 17%, respectively (OR=1.58; 95% CI, 1.77-3.22).

The incidence of SAEs due to ICH was 25% and 14%, respectively (OR=2.13; 95% CI, 1.01-4.50). The incidence of SAEs due to thromboembolism was 4% and 1%, respectively (OR=4.13; 95% CI, 0.45-37.67). And there was 1 SAE due to transfusion (OR=3.03; 95% CI, 0.12-75.37).

Attendees at the 21st

Congress of the European

Hematology Association

COPENHAGEN—Results of the phase 3 PATCH trial suggest that platelet transfusions are not beneficial and can actually cause harm in patients with intracerebral hemorrhage (ICH) associated with antiplatelet therapy.

The study showed that the odds of death or dependence at 3 months were significantly higher among patients who received a platelet transfusion plus standard care than among patients who received standard care alone.

Patients who received a platelet transfusion also had a higher incidence of severe adverse events (SAEs) during hospital admission.

“PATCH shows that platelet transfusion seems harmful for patients with antiplatelet-associated ICH,” said study investigator Maria Koopman, PhD, of Sanquin Bloodbank in Amsterdam, The Netherlands.

“Pending further evidence, we think that platelet transfusions should not be used in this patient group.”

Dr Koopman presented results of the PATCH trial at the 21st Congress of the European Hematology Association (abstract LB2234). The study was also recently published in The Lancet.

Dr Koopman noted that, worldwide, there are 2 million cases of ICH each year, and more than 25% of these patients are taking antiplatelet therapy at ICH onset.

She and her colleagues theorized that because antiplatelet therapy can lead to hematoma growth and poor outcomes, platelet transfusions might modify the effect of antiplatelet therapy and improve patient outcomes.

To test this theory, the team studied ICH patients treated at 60 hospitals in The Netherlands, Scotland, and France.

Patients and treatment

The study included patients with spontaneous supratentorial ICH who were 18 years of age or older, had been using antiplatelet therapy for at least 7 days preceding ICH, and had a Glasgow Coma Scale score of 8 or higher.

The patients were randomized 1:1 to receive either standard care alone or standard care plus a platelet transfusion within 6 hours of the start of symptoms and within 90 minutes of diagnostic brain imaging.

In all, 190 patients were randomized—97 to the transfusion arm and 93 to the standard care arm. Ultimately, 93 patients actually received a platelet transfusion, and 91 received standard care alone.

Patient characteristics were generally balanced between the treatment arms. The mean age was 74.2 in the transfusion arm and 73.5 in the standard care arm. Median scores on the Glasgow Coma Scale were 14 (range, 13-15) and 15 (range, 13-15), respectively.

Comorbidities included cerebral infarction (38.4% and 40%, respectively), hypertension (72.3% and 72.8%, respectively), diabetes (15.5% and 18.9%, respectively), myocardial infarction (23.6% and 24.4%, respectively), and peripheral artery disease (16.5% and 4.4%, respectively).

Antiplatelet therapy consisted of a cyclooxygenase (COX) inhibitor (73.2% and 83.9%, respectively), a COX inhibitor plus dipyridamole (18.6% and 14%, respectively), an adenosine diphosphate (ADP) receptor inhibitor (4.1% and 1.1%, respectively), and an ADP inhibitor plus a COX inhibitor (3.1% and 1.1%, respectively).

Efficacy

The study’s primary outcome was a shift toward death or dependence, rated on the modified Rankin Scale (mRS), at 3 months after ICH, adjusted for hospital, antiplatelet therapy, and ICH score. The primary analysis was done in the intention-to-treat population (n=97 in the transfusion arm and 93 in the standard care arm).

The investigators found the odds of death or dependence at 3 months were higher in the platelet transfusion arm than the standard care arm. The adjusted common odds ratio (OR) was 2.05 (95% CI 1.18-3.56; P=0.0114).

The study’s secondary endpoints were survival at 3 months, poor outcome (dichotomous mRS 4-6 or 3-6) at 3 months, and hematoma growth on imaging within 24 hours.

The survival rate was lower in the transfusion arm than the standard care arm, although the difference was not statistically significant—68% and 77.4%, respectively (OR=0.62; 95% CI, 0.33-1.19; P=0.15).

Poor outcome was more likely in the transfusion arm than the standard care arm, with 72.2% and 55.9% of patients, respectively, having an mRS score of 4-6 (OR=2.04; 95% CI, 1.12-3.74; P=0.0195) and 88.7% and 81.7%, respectively, having an mRS score of 3-6 (OR=1.75; 95% CI, 0.77-3.97; P=0.18).

And there was no significant difference between the arms when it came to hematoma growth, with a median of 2.01 mL (interquartile range, 0.32-9.34) in the transfusion arm and 1.16 mL (interquartile range, 0.03-4.42) in the standard care arm (P=0.81).

Safety

Safety endpoints included thromboembolic events, transfusion reactions, and SAEs during hospital admission. The safety analysis was done in the intention-to-treat population (n=97 in the transfusion arm and 93 in the standard care arm) and the as-treated population (n=93 and 91, respectively).

In the as-treated population, the incidence of SAEs was 42% in the transfusion arm and 29% in the standard care arm (OR=1.74; 95% CI, 0.96-3.17). The incidence of any fatal SAE was 24% and 17%, respectively (OR=1.58; 95% CI, 1.77-3.22).

The incidence of SAEs due to ICH was 25% and 14%, respectively (OR=2.13; 95% CI, 1.01-4.50). The incidence of SAEs due to thromboembolism was 4% and 1%, respectively (OR=4.13; 95% CI, 0.45-37.67). And there was 1 SAE due to transfusion (OR=3.03; 95% CI, 0.12-75.37).

Red blood cells

Recent studies have suggested that roughly half of patients hospitalized with traumatic brain injuries (TBIs) are anemic, but it hasn’t been clear how the anemia affects patients’ recovery.

Now, researchers have found evidence suggesting that low hemoglobin levels can negatively influence the outcomes of patients with TBIs.

The team detailed this evidence in a paper published in World Neurosurgery.

“More research is needed to develop treatment protocols for anemic patients with traumatic brain injuries,” said study author N. Scott Litofsky, MD, of the University of Missouri School of Medicine in Columbia.

“There has been a lack of consensus among physicians regarding the relationship of anemia and traumatic brain injuries on a patient’s health. Because of this uncertainty, treatment protocols are unclear and inconsistent. Our observational study found that a patient’s outcome is worse when he or she is anemic.”

The researchers studied 939 TBI patients with anemia who were admitted to a Level I trauma center.

The team assessed the relationships between patients’ initial hemoglobin level and lowest hemoglobin level during hospitalization at threshold values of ≤7, ≤8, ≤9, and ≤10 g/dL relative to their Glasgow Outcome Score within a year of surgery.

The data suggested that both initial hemoglobin levels and lowest hemoglobin levels were independent predictors of poor outcome (P<0.0001).

For each increase in initial hemoglobin level of 1 g/dL, the odds of a patient achieving a good outcome increased by 32%. For each increase in lowest hemoglobin level of 1 g/dL, the probability of a good outcome increased by 35.6%.

Female patients had worse outcomes than male patients if their initial hemoglobin levels were between 7 g/dL and 8 g/dL (P<0.05).

And receiving a blood transfusion was associated with poorer outcomes at hemoglobin levels ≤9 g/dL and ≤10 g/dL (P<0.05) but not at the lower hemoglobin thresholds.

The researchers said these data suggest clinicians may want to consider giving blood transfusions in TBI patients with hemoglobin levels of 8 g/dL or lower.

However, Dr Litofsky noted that the purpose of this study was not to propose transfusion guidelines. It was to determine the effects of anemia on TBI outcomes.

“Now that we have shown that anemia affects a patient’s recovery, further studies are needed to determine the best way to correct it,” he said. “The ultimate goal of this research is to help patients recover more quickly from traumatic brain injuries.”

Red blood cells

Recent studies have suggested that roughly half of patients hospitalized with traumatic brain injuries (TBIs) are anemic, but it hasn’t been clear how the anemia affects patients’ recovery.

Now, researchers have found evidence suggesting that low hemoglobin levels can negatively influence the outcomes of patients with TBIs.

The team detailed this evidence in a paper published in World Neurosurgery.

“More research is needed to develop treatment protocols for anemic patients with traumatic brain injuries,” said study author N. Scott Litofsky, MD, of the University of Missouri School of Medicine in Columbia.

“There has been a lack of consensus among physicians regarding the relationship of anemia and traumatic brain injuries on a patient’s health. Because of this uncertainty, treatment protocols are unclear and inconsistent. Our observational study found that a patient’s outcome is worse when he or she is anemic.”

The researchers studied 939 TBI patients with anemia who were admitted to a Level I trauma center.

The team assessed the relationships between patients’ initial hemoglobin level and lowest hemoglobin level during hospitalization at threshold values of ≤7, ≤8, ≤9, and ≤10 g/dL relative to their Glasgow Outcome Score within a year of surgery.

The data suggested that both initial hemoglobin levels and lowest hemoglobin levels were independent predictors of poor outcome (P<0.0001).

For each increase in initial hemoglobin level of 1 g/dL, the odds of a patient achieving a good outcome increased by 32%. For each increase in lowest hemoglobin level of 1 g/dL, the probability of a good outcome increased by 35.6%.

Female patients had worse outcomes than male patients if their initial hemoglobin levels were between 7 g/dL and 8 g/dL (P<0.05).

And receiving a blood transfusion was associated with poorer outcomes at hemoglobin levels ≤9 g/dL and ≤10 g/dL (P<0.05) but not at the lower hemoglobin thresholds.

The researchers said these data suggest clinicians may want to consider giving blood transfusions in TBI patients with hemoglobin levels of 8 g/dL or lower.

However, Dr Litofsky noted that the purpose of this study was not to propose transfusion guidelines. It was to determine the effects of anemia on TBI outcomes.

“Now that we have shown that anemia affects a patient’s recovery, further studies are needed to determine the best way to correct it,” he said. “The ultimate goal of this research is to help patients recover more quickly from traumatic brain injuries.”

Red blood cells

Recent studies have suggested that roughly half of patients hospitalized with traumatic brain injuries (TBIs) are anemic, but it hasn’t been clear how the anemia affects patients’ recovery.

Now, researchers have found evidence suggesting that low hemoglobin levels can negatively influence the outcomes of patients with TBIs.

The team detailed this evidence in a paper published in World Neurosurgery.

“More research is needed to develop treatment protocols for anemic patients with traumatic brain injuries,” said study author N. Scott Litofsky, MD, of the University of Missouri School of Medicine in Columbia.

“There has been a lack of consensus among physicians regarding the relationship of anemia and traumatic brain injuries on a patient’s health. Because of this uncertainty, treatment protocols are unclear and inconsistent. Our observational study found that a patient’s outcome is worse when he or she is anemic.”

The researchers studied 939 TBI patients with anemia who were admitted to a Level I trauma center.

The team assessed the relationships between patients’ initial hemoglobin level and lowest hemoglobin level during hospitalization at threshold values of ≤7, ≤8, ≤9, and ≤10 g/dL relative to their Glasgow Outcome Score within a year of surgery.

The data suggested that both initial hemoglobin levels and lowest hemoglobin levels were independent predictors of poor outcome (P<0.0001).

For each increase in initial hemoglobin level of 1 g/dL, the odds of a patient achieving a good outcome increased by 32%. For each increase in lowest hemoglobin level of 1 g/dL, the probability of a good outcome increased by 35.6%.

Female patients had worse outcomes than male patients if their initial hemoglobin levels were between 7 g/dL and 8 g/dL (P<0.05).

And receiving a blood transfusion was associated with poorer outcomes at hemoglobin levels ≤9 g/dL and ≤10 g/dL (P<0.05) but not at the lower hemoglobin thresholds.

The researchers said these data suggest clinicians may want to consider giving blood transfusions in TBI patients with hemoglobin levels of 8 g/dL or lower.

However, Dr Litofsky noted that the purpose of this study was not to propose transfusion guidelines. It was to determine the effects of anemia on TBI outcomes.

“Now that we have shown that anemia affects a patient’s recovery, further studies are needed to determine the best way to correct it,” he said. “The ultimate goal of this research is to help patients recover more quickly from traumatic brain injuries.”

Bags of plasma

Photo by Cristina Granados

Health Canada has approved the INTERCEPT Blood System for plasma, a pathogen inactivation system used to reduce the risk of transfusion-transmitted infections.

The system can be used to reduce pathogens in plasma derived from whole blood or obtained by apheresis.

The system inactivates pathogens through a photochemical process involving controlled exposure to ultraviolet light and the chemical amotosalen.

The plasma is then purified to remove the chemical and its byproducts.

Plasma, platelets, and red blood cells do not require functional DNA or RNA for therapeutic efficacy, but pathogens and white blood cells do require these nucleic acids in order to replicate.

The INTERCEPT Blood System targets this basic biological difference. Ultraviolet light is used to activate amotosalen, which binds to DNA and RNA, thereby preventing nucleic acid replication and rendering pathogens inactive.

In studies, the INTERCEPT Blood System for plasma has proven effective in reducing a broad spectrum of viruses, bacteria, spirochetes, and parasites.

However, no pathogen inactivation process has been shown to eliminate all pathogens. Certain viruses (eg, human parvovirus B19) and spores formed by certain bacteria are known to be resistant to the INTERCEPT process.

The INTERCEPT Blood System for plasma, which is marketed by Cerus Corporation, has been approved for use in Europe since 2002 and in the US since 2014.

The safety and efficacy of plasma prepared with the INTERCEPT Blood System has been evaluated in 8 clinical studies including more than 700 patients.

For more information on these studies and the system itself, see the package insert, which is available at http://intercept-canada.com.

Bags of plasma

Photo by Cristina Granados

Health Canada has approved the INTERCEPT Blood System for plasma, a pathogen inactivation system used to reduce the risk of transfusion-transmitted infections.

The system can be used to reduce pathogens in plasma derived from whole blood or obtained by apheresis.

The system inactivates pathogens through a photochemical process involving controlled exposure to ultraviolet light and the chemical amotosalen.

The plasma is then purified to remove the chemical and its byproducts.

Plasma, platelets, and red blood cells do not require functional DNA or RNA for therapeutic efficacy, but pathogens and white blood cells do require these nucleic acids in order to replicate.

The INTERCEPT Blood System targets this basic biological difference. Ultraviolet light is used to activate amotosalen, which binds to DNA and RNA, thereby preventing nucleic acid replication and rendering pathogens inactive.

In studies, the INTERCEPT Blood System for plasma has proven effective in reducing a broad spectrum of viruses, bacteria, spirochetes, and parasites.

However, no pathogen inactivation process has been shown to eliminate all pathogens. Certain viruses (eg, human parvovirus B19) and spores formed by certain bacteria are known to be resistant to the INTERCEPT process.

The INTERCEPT Blood System for plasma, which is marketed by Cerus Corporation, has been approved for use in Europe since 2002 and in the US since 2014.

The safety and efficacy of plasma prepared with the INTERCEPT Blood System has been evaluated in 8 clinical studies including more than 700 patients.

For more information on these studies and the system itself, see the package insert, which is available at http://intercept-canada.com.

Bags of plasma

Photo by Cristina Granados

Health Canada has approved the INTERCEPT Blood System for plasma, a pathogen inactivation system used to reduce the risk of transfusion-transmitted infections.

The system can be used to reduce pathogens in plasma derived from whole blood or obtained by apheresis.

The system inactivates pathogens through a photochemical process involving controlled exposure to ultraviolet light and the chemical amotosalen.

The plasma is then purified to remove the chemical and its byproducts.

Plasma, platelets, and red blood cells do not require functional DNA or RNA for therapeutic efficacy, but pathogens and white blood cells do require these nucleic acids in order to replicate.

The INTERCEPT Blood System targets this basic biological difference. Ultraviolet light is used to activate amotosalen, which binds to DNA and RNA, thereby preventing nucleic acid replication and rendering pathogens inactive.

In studies, the INTERCEPT Blood System for plasma has proven effective in reducing a broad spectrum of viruses, bacteria, spirochetes, and parasites.

However, no pathogen inactivation process has been shown to eliminate all pathogens. Certain viruses (eg, human parvovirus B19) and spores formed by certain bacteria are known to be resistant to the INTERCEPT process.

The INTERCEPT Blood System for plasma, which is marketed by Cerus Corporation, has been approved for use in Europe since 2002 and in the US since 2014.

The safety and efficacy of plasma prepared with the INTERCEPT Blood System has been evaluated in 8 clinical studies including more than 700 patients.

For more information on these studies and the system itself, see the package insert, which is available at http://intercept-canada.com.

Blood samples

Photo by Graham Colm

A new technique provides a way to keep blood samples stable for long periods at high temperatures, according to research published in PNAS.

Investigators found they could keep blood samples stable for nearly 3 months at temperatures as high as 113 degrees F by encapsulating them in air-dried silk protein.

The team believes this technique could have broad applications for clinical care and research.

“This approach should facilitate outpatient blood collection for disease screening and monitoring, particularly for underserved populations, and also serve needs of researchers and clinicians without access to centralized testing facilities,” said study author David L. Kaplan, PhD, of the Department of Biomedical Engineering at Tufts University in Medford, Massachusetts.

For this approach, Dr Kaplan and his colleagues mixed a solution or a powder of purified silk fibroin protein extracted from silkworm cocoons with blood or plasma and air-dried the mixture.

The air-dried silk films were stored at temperatures between 22 and 45 degrees C (71.6 to 113 degrees F). At set intervals, the researchers recovered the encapsulated blood samples by dissolving the films in water and analyzed them.

“We found that biomarkers could be successfully analyzed even after storage for 84 days at temperatures up to 113 degrees F,” said study author Jonathan A. Kluge, PhD, formerly of Tufts University but now at Vaxess Technologies in Cambridge, Massachusetts.

“Encapsulation of samples in silk provided better protection than the traditional approach of drying on paper, especially at these elevated temperatures, which a shipment might encounter during overseas or summer transport.”

The investigators noted that the silk-based technique requires accurate starting volumes of the blood or other specimens to be known, and salts or other buffers are needed to reconstitute samples for accurate testing of certain markers.

Blood samples

Photo by Graham Colm

A new technique provides a way to keep blood samples stable for long periods at high temperatures, according to research published in PNAS.

Investigators found they could keep blood samples stable for nearly 3 months at temperatures as high as 113 degrees F by encapsulating them in air-dried silk protein.

The team believes this technique could have broad applications for clinical care and research.

“This approach should facilitate outpatient blood collection for disease screening and monitoring, particularly for underserved populations, and also serve needs of researchers and clinicians without access to centralized testing facilities,” said study author David L. Kaplan, PhD, of the Department of Biomedical Engineering at Tufts University in Medford, Massachusetts.

For this approach, Dr Kaplan and his colleagues mixed a solution or a powder of purified silk fibroin protein extracted from silkworm cocoons with blood or plasma and air-dried the mixture.

The air-dried silk films were stored at temperatures between 22 and 45 degrees C (71.6 to 113 degrees F). At set intervals, the researchers recovered the encapsulated blood samples by dissolving the films in water and analyzed them.

“We found that biomarkers could be successfully analyzed even after storage for 84 days at temperatures up to 113 degrees F,” said study author Jonathan A. Kluge, PhD, formerly of Tufts University but now at Vaxess Technologies in Cambridge, Massachusetts.

“Encapsulation of samples in silk provided better protection than the traditional approach of drying on paper, especially at these elevated temperatures, which a shipment might encounter during overseas or summer transport.”

The investigators noted that the silk-based technique requires accurate starting volumes of the blood or other specimens to be known, and salts or other buffers are needed to reconstitute samples for accurate testing of certain markers.

Blood samples

Photo by Graham Colm

A new technique provides a way to keep blood samples stable for long periods at high temperatures, according to research published in PNAS.

Investigators found they could keep blood samples stable for nearly 3 months at temperatures as high as 113 degrees F by encapsulating them in air-dried silk protein.

The team believes this technique could have broad applications for clinical care and research.

“This approach should facilitate outpatient blood collection for disease screening and monitoring, particularly for underserved populations, and also serve needs of researchers and clinicians without access to centralized testing facilities,” said study author David L. Kaplan, PhD, of the Department of Biomedical Engineering at Tufts University in Medford, Massachusetts.

For this approach, Dr Kaplan and his colleagues mixed a solution or a powder of purified silk fibroin protein extracted from silkworm cocoons with blood or plasma and air-dried the mixture.

The air-dried silk films were stored at temperatures between 22 and 45 degrees C (71.6 to 113 degrees F). At set intervals, the researchers recovered the encapsulated blood samples by dissolving the films in water and analyzed them.

“We found that biomarkers could be successfully analyzed even after storage for 84 days at temperatures up to 113 degrees F,” said study author Jonathan A. Kluge, PhD, formerly of Tufts University but now at Vaxess Technologies in Cambridge, Massachusetts.

“Encapsulation of samples in silk provided better protection than the traditional approach of drying on paper, especially at these elevated temperatures, which a shipment might encounter during overseas or summer transport.”

The investigators noted that the silk-based technique requires accurate starting volumes of the blood or other specimens to be known, and salts or other buffers are needed to reconstitute samples for accurate testing of certain markers.

Blood sample collection

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.

The test, Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test), is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from patients meeting criteria for testing outlined by the Centers for Disease Control and Prevention (CDC).

The Zika RT-PCR test is the first test from a commercial laboratory provider to be granted an EUA for testing patients for Zika virus RNA. The test was developed by Focus Diagnostics, Inc., a subsidiary of Quest Diagnostics.

About the EUA

The Zika RT-PCR test has not been FDA cleared or approved. An EUA allows the use of unapproved medical products or unapproved uses of approved medical products in an emergency.

The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

The FDA issued the EUA for the Zika RT-PCR test based on data submitted by Focus Diagnostics, Inc., and on the US Secretary of Health and Human Services’ (HHS) declaration that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Zika virus and/or diagnosis of Zika virus infection.

This EUA will terminate when the HHS Secretary’s declaration terminates, unless the FDA revokes it sooner.

Until now, the only Zika tests authorized by the FDA under EUA were available from the CDC and were only used in qualified laboratories designated by the CDC. These are the Trioplex Real-time RT-PCR Assay and the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA).

About the test

Quest Diagnostics plans to make the Zika RT-PCR test broadly available for patient testing early in the week of May 2.

The Zika RT-PCR test is intended for use by clinical laboratory personnel qualified by state and federal regulations who have received specific training on the use of the test in qualified laboratories designated by Focus Diagnostics, Inc., and certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests.

The test can potentially be performed at any CLIA high-complexity laboratory in the Quest Diagnostics network, which includes several dozen CLIA high-complexity labs in the US, including in Toa Baja, Puerto Rico.

Within the US, positive results of this test must be reported to the CDC.

The CDC recommends RT-PCR testing for Zika infection during approximately the first 7 days of the onset of symptoms for certain patients, including:

• Individuals with symptoms suggestive of Zika infection who have traveled within the last 2 weeks to an area with ongoing transmission
• Asymptomatic pregnant women with a history of residence in or travel to areas of active Zika infection
• Asymptomatic pregnant women whose male sexual partners have traveled to or lived in an area of active Zika infection
• Infants born to mothers who live in or traveled to areas with Zika virus transmission during their pregnancy, including both molecular and serologic testing of infants who are being evaluated for evidence of a congenital Zika virus infection.

A negative test result does not preclude infection, and additional serological testing to evaluate the body’s immune response to infection may be considered within 2 to 12 weeks after symptom onset.

For more information on the Zika RT-PCR test, visit www.QuestDiagnostics.com/Zika.

Blood sample collection

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.

The test, Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test), is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from patients meeting criteria for testing outlined by the Centers for Disease Control and Prevention (CDC).

The Zika RT-PCR test is the first test from a commercial laboratory provider to be granted an EUA for testing patients for Zika virus RNA. The test was developed by Focus Diagnostics, Inc., a subsidiary of Quest Diagnostics.

About the EUA

The Zika RT-PCR test has not been FDA cleared or approved. An EUA allows the use of unapproved medical products or unapproved uses of approved medical products in an emergency.

The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

The FDA issued the EUA for the Zika RT-PCR test based on data submitted by Focus Diagnostics, Inc., and on the US Secretary of Health and Human Services’ (HHS) declaration that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Zika virus and/or diagnosis of Zika virus infection.

This EUA will terminate when the HHS Secretary’s declaration terminates, unless the FDA revokes it sooner.

Until now, the only Zika tests authorized by the FDA under EUA were available from the CDC and were only used in qualified laboratories designated by the CDC. These are the Trioplex Real-time RT-PCR Assay and the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA).

About the test

Quest Diagnostics plans to make the Zika RT-PCR test broadly available for patient testing early in the week of May 2.

The Zika RT-PCR test is intended for use by clinical laboratory personnel qualified by state and federal regulations who have received specific training on the use of the test in qualified laboratories designated by Focus Diagnostics, Inc., and certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests.

The test can potentially be performed at any CLIA high-complexity laboratory in the Quest Diagnostics network, which includes several dozen CLIA high-complexity labs in the US, including in Toa Baja, Puerto Rico.

Within the US, positive results of this test must be reported to the CDC.

The CDC recommends RT-PCR testing for Zika infection during approximately the first 7 days of the onset of symptoms for certain patients, including:

• Individuals with symptoms suggestive of Zika infection who have traveled within the last 2 weeks to an area with ongoing transmission
• Asymptomatic pregnant women with a history of residence in or travel to areas of active Zika infection
• Asymptomatic pregnant women whose male sexual partners have traveled to or lived in an area of active Zika infection
• Infants born to mothers who live in or traveled to areas with Zika virus transmission during their pregnancy, including both molecular and serologic testing of infants who are being evaluated for evidence of a congenital Zika virus infection.

A negative test result does not preclude infection, and additional serological testing to evaluate the body’s immune response to infection may be considered within 2 to 12 weeks after symptom onset.

For more information on the Zika RT-PCR test, visit www.QuestDiagnostics.com/Zika.

Blood sample collection

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.

The test, Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test), is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from patients meeting criteria for testing outlined by the Centers for Disease Control and Prevention (CDC).

The Zika RT-PCR test is the first test from a commercial laboratory provider to be granted an EUA for testing patients for Zika virus RNA. The test was developed by Focus Diagnostics, Inc., a subsidiary of Quest Diagnostics.

About the EUA

The Zika RT-PCR test has not been FDA cleared or approved. An EUA allows the use of unapproved medical products or unapproved uses of approved medical products in an emergency.

The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

The FDA issued the EUA for the Zika RT-PCR test based on data submitted by Focus Diagnostics, Inc., and on the US Secretary of Health and Human Services’ (HHS) declaration that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Zika virus and/or diagnosis of Zika virus infection.

This EUA will terminate when the HHS Secretary’s declaration terminates, unless the FDA revokes it sooner.

Until now, the only Zika tests authorized by the FDA under EUA were available from the CDC and were only used in qualified laboratories designated by the CDC. These are the Trioplex Real-time RT-PCR Assay and the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA).

About the test

Quest Diagnostics plans to make the Zika RT-PCR test broadly available for patient testing early in the week of May 2.

The Zika RT-PCR test is intended for use by clinical laboratory personnel qualified by state and federal regulations who have received specific training on the use of the test in qualified laboratories designated by Focus Diagnostics, Inc., and certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests.

The test can potentially be performed at any CLIA high-complexity laboratory in the Quest Diagnostics network, which includes several dozen CLIA high-complexity labs in the US, including in Toa Baja, Puerto Rico.

Within the US, positive results of this test must be reported to the CDC.

The CDC recommends RT-PCR testing for Zika infection during approximately the first 7 days of the onset of symptoms for certain patients, including:

• Individuals with symptoms suggestive of Zika infection who have traveled within the last 2 weeks to an area with ongoing transmission
• Asymptomatic pregnant women with a history of residence in or travel to areas of active Zika infection
• Asymptomatic pregnant women whose male sexual partners have traveled to or lived in an area of active Zika infection
• Infants born to mothers who live in or traveled to areas with Zika virus transmission during their pregnancy, including both molecular and serologic testing of infants who are being evaluated for evidence of a congenital Zika virus infection.

A negative test result does not preclude infection, and additional serological testing to evaluate the body’s immune response to infection may be considered within 2 to 12 weeks after symptom onset.

For more information on the Zika RT-PCR test, visit www.QuestDiagnostics.com/Zika.

Cord blood donation

Photo courtesy of NHS

New research suggests an RNA-binding protein can be used to expand hematopoietic stem cells (HSCs) derived from umbilical cord blood.

Investigators found the protein, Musashi-2 (MSI2), regulates the function and development of cord-blood derived HSCs, and overexpressing MSI2 can significantly expand both short-term and long-term repopulating HSCs.

“By expanding the stem cells as we have done, many more donated [cord blood] samples could now be used for transplants,” said Kristin Hope, PhD, of McMaster University in Hamilton, Ontario, Canada.

“Providing enhanced numbers of stem cells for transplantation could alleviate some of the current post-transplantation complications and allow for faster recoveries, in turn, reducing overall healthcare costs and wait times for newly diagnosed patients seeking treatment.”

Dr Hope and her colleagues described this exploration of HSC expansion in Nature.

The team first found that expression of MSI2 messenger RNA was elevated in primitive cord blood hematopoietic stem and progenitor cells (HSPCs), but it decreased during differentiation.

They then found that overexpressing MSI2 enhances the activity of cord blood progenitors in vitro and increases the number of short-term repopulating HSCs in vitro and in vivo.

During in vitro culture, MSI2-overexpressing cells were 2.3-fold more abundant than control cells at 7 days and 6-fold more abundant at 21 days. After 7 days, MSI2-overexpressing cells showed a cumulative 9.3-fold increase in colony-forming cells but no changes in cell cycling or death.

MSI2-overexpressing short-term repopulating cells (STRCs) yielded 1.8-fold more primitive CD34+ cells than control STRCs. And the MSI2-overexpressing STRCs prompted a 17-fold increase in functional STRCs.

Furthermore, 100% of mice transplanted with MSI2-overexpressing STRCs were engrafted at 6.5 weeks, compared to 50% of mice transplanted with control STRCs.

Additional transplant experiments showed that MSI2 overexpression also impacted long-term HSCs (LT-HSCs). Compared to control cells, MSI2-overexpressing cells increased the percentage of GFP+ HSCs in the bone marrow 4.6-fold and the frequency of LT-HSCs 3.5-fold.

The researchers said the increase in LT-HSC frequency corresponded to MSI2-overexpressing GFP+ HSCs having expanded in mice 2.4-fold over input. With control HSCs, on the other hand, there was a 1.5-fold decrease.

In ex vivo culture, MSI2 overexpression induced a cumulative 23-fold expansion of secondary LT-HSCs when compared to control LT-HSCs.

Finally, the researchers performed a global analysis of MSI2–RNA interactions and found that MSI2 mediates HSPC self-renewal and ex vivo expansion by coordinating the post-transcriptional regulation of proteins belonging to a shared self-renewal regulatory pathway.

“We’ve really shone a light on the way these stem cells work,” Dr Hope said. “We now understand how they operate at a completely new level, and that provides us with a serious advantage in determining how to maximize these stem cells in therapeutics. With this newfound ability to control the regeneration of these cells, more people will be able to get the treatment they need.”

Cord blood donation

Photo courtesy of NHS

New research suggests an RNA-binding protein can be used to expand hematopoietic stem cells (HSCs) derived from umbilical cord blood.

Investigators found the protein, Musashi-2 (MSI2), regulates the function and development of cord-blood derived HSCs, and overexpressing MSI2 can significantly expand both short-term and long-term repopulating HSCs.

“By expanding the stem cells as we have done, many more donated [cord blood] samples could now be used for transplants,” said Kristin Hope, PhD, of McMaster University in Hamilton, Ontario, Canada.

“Providing enhanced numbers of stem cells for transplantation could alleviate some of the current post-transplantation complications and allow for faster recoveries, in turn, reducing overall healthcare costs and wait times for newly diagnosed patients seeking treatment.”

Dr Hope and her colleagues described this exploration of HSC expansion in Nature.

The team first found that expression of MSI2 messenger RNA was elevated in primitive cord blood hematopoietic stem and progenitor cells (HSPCs), but it decreased during differentiation.

They then found that overexpressing MSI2 enhances the activity of cord blood progenitors in vitro and increases the number of short-term repopulating HSCs in vitro and in vivo.

During in vitro culture, MSI2-overexpressing cells were 2.3-fold more abundant than control cells at 7 days and 6-fold more abundant at 21 days. After 7 days, MSI2-overexpressing cells showed a cumulative 9.3-fold increase in colony-forming cells but no changes in cell cycling or death.

MSI2-overexpressing short-term repopulating cells (STRCs) yielded 1.8-fold more primitive CD34+ cells than control STRCs. And the MSI2-overexpressing STRCs prompted a 17-fold increase in functional STRCs.

Furthermore, 100% of mice transplanted with MSI2-overexpressing STRCs were engrafted at 6.5 weeks, compared to 50% of mice transplanted with control STRCs.

Additional transplant experiments showed that MSI2 overexpression also impacted long-term HSCs (LT-HSCs). Compared to control cells, MSI2-overexpressing cells increased the percentage of GFP+ HSCs in the bone marrow 4.6-fold and the frequency of LT-HSCs 3.5-fold.

The researchers said the increase in LT-HSC frequency corresponded to MSI2-overexpressing GFP+ HSCs having expanded in mice 2.4-fold over input. With control HSCs, on the other hand, there was a 1.5-fold decrease.

In ex vivo culture, MSI2 overexpression induced a cumulative 23-fold expansion of secondary LT-HSCs when compared to control LT-HSCs.

Finally, the researchers performed a global analysis of MSI2–RNA interactions and found that MSI2 mediates HSPC self-renewal and ex vivo expansion by coordinating the post-transcriptional regulation of proteins belonging to a shared self-renewal regulatory pathway.

“We’ve really shone a light on the way these stem cells work,” Dr Hope said. “We now understand how they operate at a completely new level, and that provides us with a serious advantage in determining how to maximize these stem cells in therapeutics. With this newfound ability to control the regeneration of these cells, more people will be able to get the treatment they need.”

Cord blood donation

Photo courtesy of NHS

New research suggests an RNA-binding protein can be used to expand hematopoietic stem cells (HSCs) derived from umbilical cord blood.

Investigators found the protein, Musashi-2 (MSI2), regulates the function and development of cord-blood derived HSCs, and overexpressing MSI2 can significantly expand both short-term and long-term repopulating HSCs.

“By expanding the stem cells as we have done, many more donated [cord blood] samples could now be used for transplants,” said Kristin Hope, PhD, of McMaster University in Hamilton, Ontario, Canada.

“Providing enhanced numbers of stem cells for transplantation could alleviate some of the current post-transplantation complications and allow for faster recoveries, in turn, reducing overall healthcare costs and wait times for newly diagnosed patients seeking treatment.”

Dr Hope and her colleagues described this exploration of HSC expansion in Nature.

The team first found that expression of MSI2 messenger RNA was elevated in primitive cord blood hematopoietic stem and progenitor cells (HSPCs), but it decreased during differentiation.

They then found that overexpressing MSI2 enhances the activity of cord blood progenitors in vitro and increases the number of short-term repopulating HSCs in vitro and in vivo.

During in vitro culture, MSI2-overexpressing cells were 2.3-fold more abundant than control cells at 7 days and 6-fold more abundant at 21 days. After 7 days, MSI2-overexpressing cells showed a cumulative 9.3-fold increase in colony-forming cells but no changes in cell cycling or death.

MSI2-overexpressing short-term repopulating cells (STRCs) yielded 1.8-fold more primitive CD34+ cells than control STRCs. And the MSI2-overexpressing STRCs prompted a 17-fold increase in functional STRCs.

Furthermore, 100% of mice transplanted with MSI2-overexpressing STRCs were engrafted at 6.5 weeks, compared to 50% of mice transplanted with control STRCs.

Additional transplant experiments showed that MSI2 overexpression also impacted long-term HSCs (LT-HSCs). Compared to control cells, MSI2-overexpressing cells increased the percentage of GFP+ HSCs in the bone marrow 4.6-fold and the frequency of LT-HSCs 3.5-fold.

The researchers said the increase in LT-HSC frequency corresponded to MSI2-overexpressing GFP+ HSCs having expanded in mice 2.4-fold over input. With control HSCs, on the other hand, there was a 1.5-fold decrease.

In ex vivo culture, MSI2 overexpression induced a cumulative 23-fold expansion of secondary LT-HSCs when compared to control LT-HSCs.

Finally, the researchers performed a global analysis of MSI2–RNA interactions and found that MSI2 mediates HSPC self-renewal and ex vivo expansion by coordinating the post-transcriptional regulation of proteins belonging to a shared self-renewal regulatory pathway.

“We’ve really shone a light on the way these stem cells work,” Dr Hope said. “We now understand how they operate at a completely new level, and that provides us with a serious advantage in determining how to maximize these stem cells in therapeutics. With this newfound ability to control the regeneration of these cells, more people will be able to get the treatment they need.”

Blood samples

Photo by William Weinert

The US Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA) have issued an interim guidance for protecting workers from occupational exposure to the Zika virus.

The guidance is for healthcare and laboratory workers, outdoor workers, mosquito control workers, and business travelers.

It includes recommendations to help protect these workers from mosquito bites and exposure to an infected person’s blood or other body fluids.

The CDC noted that, although Zika virus is primarily spread by infected mosquitoes, exposure to an infected person’s blood or other body fluids may also result in transmission.

So healthcare workers who may be exposed to contaminated blood or other potentially infectious materials from people infected with Zika virus may require additional protection.

Recommendations for healthcare and laboratory workers

Employers and workers in healthcare settings and laboratories should follow standard infection control and biosafety practices (including universal precautions) as appropriate to prevent or minimize the risk of Zika virus transmission.

Standard precautions include, but are not limited to, hand hygiene and the use of personal protective equipment (PPE) to avoid direct contact with blood and other potentially infectious materials, including laboratory specimens/samples. PPE may include gloves, gowns, masks, and eye protection.

Hand hygiene consists of washing with soap and water or using alcohol-based hand rubs containing at least 60% alcohol. Soap and water are best for hands that are visibly soiled. Perform hand hygiene before and after any contact with a patient, after any contact with potentially infectious material, and before putting on and upon removing PPE, including gloves.

Laboratories should ensure that their facilities and practices meet the appropriate Biosafety Level for the type of work being conducted (including the specific biologic agents—in this case, Zika virus) in the laboratory.

Employers should ensure that workers follow workplace standard operating procedures (eg, workplace exposure control plans) and use the engineering controls and work practices available in the workplace to prevent exposure to blood or other potentially infectious materials.

Employers should ensure workers do not bend, recap, or remove contaminated needles or other contaminated sharps. Properly dispose of these items in closable, puncture-resistant, leak-proof, and labeled or color-coded containers. Workers should use sharps with engineered sharps injury protection to avoid sharps-related injuries.

Additional details and recommendations for business travelers, outdoor workers, and mosquito control workers are available in the full guidance document.

The CDC said it will continue to update this guidance based on accumulating evidence. For updates, visit www.cdc.gov/zika.

Blood samples

Photo by William Weinert

The US Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA) have issued an interim guidance for protecting workers from occupational exposure to the Zika virus.

The guidance is for healthcare and laboratory workers, outdoor workers, mosquito control workers, and business travelers.

It includes recommendations to help protect these workers from mosquito bites and exposure to an infected person’s blood or other body fluids.

The CDC noted that, although Zika virus is primarily spread by infected mosquitoes, exposure to an infected person’s blood or other body fluids may also result in transmission.

So healthcare workers who may be exposed to contaminated blood or other potentially infectious materials from people infected with Zika virus may require additional protection.

Recommendations for healthcare and laboratory workers

Employers and workers in healthcare settings and laboratories should follow standard infection control and biosafety practices (including universal precautions) as appropriate to prevent or minimize the risk of Zika virus transmission.

Standard precautions include, but are not limited to, hand hygiene and the use of personal protective equipment (PPE) to avoid direct contact with blood and other potentially infectious materials, including laboratory specimens/samples. PPE may include gloves, gowns, masks, and eye protection.

Hand hygiene consists of washing with soap and water or using alcohol-based hand rubs containing at least 60% alcohol. Soap and water are best for hands that are visibly soiled. Perform hand hygiene before and after any contact with a patient, after any contact with potentially infectious material, and before putting on and upon removing PPE, including gloves.

Laboratories should ensure that their facilities and practices meet the appropriate Biosafety Level for the type of work being conducted (including the specific biologic agents—in this case, Zika virus) in the laboratory.

Employers should ensure that workers follow workplace standard operating procedures (eg, workplace exposure control plans) and use the engineering controls and work practices available in the workplace to prevent exposure to blood or other potentially infectious materials.

Employers should ensure workers do not bend, recap, or remove contaminated needles or other contaminated sharps. Properly dispose of these items in closable, puncture-resistant, leak-proof, and labeled or color-coded containers. Workers should use sharps with engineered sharps injury protection to avoid sharps-related injuries.

Additional details and recommendations for business travelers, outdoor workers, and mosquito control workers are available in the full guidance document.

The CDC said it will continue to update this guidance based on accumulating evidence. For updates, visit www.cdc.gov/zika.

Blood samples

Photo by William Weinert

The US Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA) have issued an interim guidance for protecting workers from occupational exposure to the Zika virus.

The guidance is for healthcare and laboratory workers, outdoor workers, mosquito control workers, and business travelers.

It includes recommendations to help protect these workers from mosquito bites and exposure to an infected person’s blood or other body fluids.

The CDC noted that, although Zika virus is primarily spread by infected mosquitoes, exposure to an infected person’s blood or other body fluids may also result in transmission.

So healthcare workers who may be exposed to contaminated blood or other potentially infectious materials from people infected with Zika virus may require additional protection.

Recommendations for healthcare and laboratory workers

Employers and workers in healthcare settings and laboratories should follow standard infection control and biosafety practices (including universal precautions) as appropriate to prevent or minimize the risk of Zika virus transmission.

Standard precautions include, but are not limited to, hand hygiene and the use of personal protective equipment (PPE) to avoid direct contact with blood and other potentially infectious materials, including laboratory specimens/samples. PPE may include gloves, gowns, masks, and eye protection.

Hand hygiene consists of washing with soap and water or using alcohol-based hand rubs containing at least 60% alcohol. Soap and water are best for hands that are visibly soiled. Perform hand hygiene before and after any contact with a patient, after any contact with potentially infectious material, and before putting on and upon removing PPE, including gloves.

Laboratories should ensure that their facilities and practices meet the appropriate Biosafety Level for the type of work being conducted (including the specific biologic agents—in this case, Zika virus) in the laboratory.

Employers should ensure that workers follow workplace standard operating procedures (eg, workplace exposure control plans) and use the engineering controls and work practices available in the workplace to prevent exposure to blood or other potentially infectious materials.

Employers should ensure workers do not bend, recap, or remove contaminated needles or other contaminated sharps. Properly dispose of these items in closable, puncture-resistant, leak-proof, and labeled or color-coded containers. Workers should use sharps with engineered sharps injury protection to avoid sharps-related injuries.

Additional details and recommendations for business travelers, outdoor workers, and mosquito control workers are available in the full guidance document.

The CDC said it will continue to update this guidance based on accumulating evidence. For updates, visit www.cdc.gov/zika.

Blood sample collection

Photo by Juan D. Alfonso

The US Department of Health and Human Services (HHS) is providing financial support for a clinical trial of the cobas® Zika test, which is designed to screen blood donations for Zika virus.

The US Food and Drug Administration (FDA) recently authorized the use of this test, under an investigational new drug application protocol, for screening donated blood in areas with active, mosquito-borne transmission of Zika virus.

This means the cobas® Zika test can be used by US blood screening laboratories, but the laboratories will need to be enrolled in and contracted into the clinical trial as specified and agreed with the FDA’s Center for Biologics Evaluation and Research.

Now, the HHS has announced that the Biomedical Advanced Research and Development Authority (BARDA) is supporting the trial, which will evaluate the sensitivity and specificity of the test in its actual use.

The trial is necessary for Roche, the company developing the cobas® Zika test, to apply for FDA approval for commercial marketing.

“BARDA staff has worked closely with our partners at FDA and the Office of the Assistant Secretary of Health to ensure the continuity and safety of the US blood supply,” said Richard Hatchett, BARDA’s acting director.

“Today’s award to Roche is an important step towards securing the safety of the blood supply in Puerto Rico and in the rest of the United States.”

Under the 1-year, $354,500 contract, Roche will study blood samples to confirm whether the test accurately and reliably detects and identifies Zika virus, even when present in very low concentrations in donor blood.

Blood sample collection

Photo by Juan D. Alfonso

The US Department of Health and Human Services (HHS) is providing financial support for a clinical trial of the cobas® Zika test, which is designed to screen blood donations for Zika virus.

The US Food and Drug Administration (FDA) recently authorized the use of this test, under an investigational new drug application protocol, for screening donated blood in areas with active, mosquito-borne transmission of Zika virus.

This means the cobas® Zika test can be used by US blood screening laboratories, but the laboratories will need to be enrolled in and contracted into the clinical trial as specified and agreed with the FDA’s Center for Biologics Evaluation and Research.

Now, the HHS has announced that the Biomedical Advanced Research and Development Authority (BARDA) is supporting the trial, which will evaluate the sensitivity and specificity of the test in its actual use.

The trial is necessary for Roche, the company developing the cobas® Zika test, to apply for FDA approval for commercial marketing.

“BARDA staff has worked closely with our partners at FDA and the Office of the Assistant Secretary of Health to ensure the continuity and safety of the US blood supply,” said Richard Hatchett, BARDA’s acting director.

“Today’s award to Roche is an important step towards securing the safety of the blood supply in Puerto Rico and in the rest of the United States.”

Under the 1-year, $354,500 contract, Roche will study blood samples to confirm whether the test accurately and reliably detects and identifies Zika virus, even when present in very low concentrations in donor blood.

Blood sample collection

Photo by Juan D. Alfonso

The US Department of Health and Human Services (HHS) is providing financial support for a clinical trial of the cobas® Zika test, which is designed to screen blood donations for Zika virus.

The US Food and Drug Administration (FDA) recently authorized the use of this test, under an investigational new drug application protocol, for screening donated blood in areas with active, mosquito-borne transmission of Zika virus.

This means the cobas® Zika test can be used by US blood screening laboratories, but the laboratories will need to be enrolled in and contracted into the clinical trial as specified and agreed with the FDA’s Center for Biologics Evaluation and Research.

Now, the HHS has announced that the Biomedical Advanced Research and Development Authority (BARDA) is supporting the trial, which will evaluate the sensitivity and specificity of the test in its actual use.

The trial is necessary for Roche, the company developing the cobas® Zika test, to apply for FDA approval for commercial marketing.

“BARDA staff has worked closely with our partners at FDA and the Office of the Assistant Secretary of Health to ensure the continuity and safety of the US blood supply,” said Richard Hatchett, BARDA’s acting director.

“Today’s award to Roche is an important step towards securing the safety of the blood supply in Puerto Rico and in the rest of the United States.”

Under the 1-year, $354,500 contract, Roche will study blood samples to confirm whether the test accurately and reliably detects and identifies Zika virus, even when present in very low concentrations in donor blood.

Blood in bags and vials

Photo by Daniel Gay

A pathogen-reduction system can safely minimize the risk of malaria transmitted via blood transfusion, according to a randomized trial.

The Mirasol pathogen-reduction technology system uses ultraviolet light energy and riboflavin to reduce the pathogen load and inactivate white blood cells in blood products.

In the current study, the system significantly reduced the transmission of malaria-causing Plasmodium parasites in patients receiving whole blood.

“This is the first study to look at the potential of pathogen-reduction technology in a real-world treatment setting and finds that, although the risk of malaria transmission is not completely eliminated, the risk is severely reduced,” said Jean-Pierre Allain, MD, of the University of Cambridge in the UK.

Dr Allain and his colleagues described this research in The Lancet. The work was funded by TerumoBCT Inc., the company developing the Mirasol system.

The trial included 223 adult patients from the Komfo Anokye Teaching Hospital in Kumasi, Ghana, who required a blood transfusion because of severe anemia or hemorrhage and were expected to remain in the hospital for at least 3 consecutive days after the initial transfusion.

The patients were randomized via computer to receive a transfusion with pathogen-reduced whole blood (treated) or whole blood that was prepared and transfused by standard local practice (untreated). Patients, healthcare providers, and data collectors were blinded to the treatment allocation.

The researchers analyzed blood samples for all of the recipients on the day of the transfusion and 1, 3, 7, and 28 days later. By studying the sequences of Plasmodium genes present in the blood, the team was able to tell whether the patients were likely to be carrying the donor parasite after the transfusion.

In all, 214 patients completed the protocol as planned—107 who received treated blood and 107 who received untreated blood.

A total of 65 patients were not previously carrying a Plasmodium parasite but received parasitemic blood. Twenty-eight of these patients received treated blood, and 37 received untreated blood.

The incidence of transfusion-transmitted malaria was significantly lower for the group that received the treated blood. Twenty-two percent of patients (8/37) who received untreated blood later tested positive for the malaria parasite, compared with 4% (1/28) of patients who received treated blood (P=0.039).

The researchers noted that coagulation parameters, platelet counts, and hemostatic status were similar whether patients received treated or untreated blood.

The Mirasol system did not appear to affect the coagulation properties of the blood, and patients who received the treated blood had slightly fewer allergic reactions than those who received the untreated blood (5% vs 8%).

The percentage of patients reporting at least 1 treatment-emergent adverse event (TEAE) was similar between the groups—43% in the treated-blood group and 39% in the untreated-blood group.

Likewise, there were no significant differences between the groups in the incidence of serious TEAEs (12% vs 8%), life-threatening TEAEs (3% for both), hospital admission (5% vs 4%), or death (7% vs 5%). The researchers noted that none of the deaths were related to transfusion or pathogen-reduction technology.

The team said additional studies of this technology are needed in larger populations—in particular, at-risk populations such as young children and pregnant mothers.

Blood in bags and vials

Photo by Daniel Gay

A pathogen-reduction system can safely minimize the risk of malaria transmitted via blood transfusion, according to a randomized trial.

The Mirasol pathogen-reduction technology system uses ultraviolet light energy and riboflavin to reduce the pathogen load and inactivate white blood cells in blood products.

In the current study, the system significantly reduced the transmission of malaria-causing Plasmodium parasites in patients receiving whole blood.

“This is the first study to look at the potential of pathogen-reduction technology in a real-world treatment setting and finds that, although the risk of malaria transmission is not completely eliminated, the risk is severely reduced,” said Jean-Pierre Allain, MD, of the University of Cambridge in the UK.

Dr Allain and his colleagues described this research in The Lancet. The work was funded by TerumoBCT Inc., the company developing the Mirasol system.

The trial included 223 adult patients from the Komfo Anokye Teaching Hospital in Kumasi, Ghana, who required a blood transfusion because of severe anemia or hemorrhage and were expected to remain in the hospital for at least 3 consecutive days after the initial transfusion.

The patients were randomized via computer to receive a transfusion with pathogen-reduced whole blood (treated) or whole blood that was prepared and transfused by standard local practice (untreated). Patients, healthcare providers, and data collectors were blinded to the treatment allocation.

The researchers analyzed blood samples for all of the recipients on the day of the transfusion and 1, 3, 7, and 28 days later. By studying the sequences of Plasmodium genes present in the blood, the team was able to tell whether the patients were likely to be carrying the donor parasite after the transfusion.

In all, 214 patients completed the protocol as planned—107 who received treated blood and 107 who received untreated blood.

A total of 65 patients were not previously carrying a Plasmodium parasite but received parasitemic blood. Twenty-eight of these patients received treated blood, and 37 received untreated blood.

The incidence of transfusion-transmitted malaria was significantly lower for the group that received the treated blood. Twenty-two percent of patients (8/37) who received untreated blood later tested positive for the malaria parasite, compared with 4% (1/28) of patients who received treated blood (P=0.039).

The researchers noted that coagulation parameters, platelet counts, and hemostatic status were similar whether patients received treated or untreated blood.

The Mirasol system did not appear to affect the coagulation properties of the blood, and patients who received the treated blood had slightly fewer allergic reactions than those who received the untreated blood (5% vs 8%).

The percentage of patients reporting at least 1 treatment-emergent adverse event (TEAE) was similar between the groups—43% in the treated-blood group and 39% in the untreated-blood group.

Likewise, there were no significant differences between the groups in the incidence of serious TEAEs (12% vs 8%), life-threatening TEAEs (3% for both), hospital admission (5% vs 4%), or death (7% vs 5%). The researchers noted that none of the deaths were related to transfusion or pathogen-reduction technology.

The team said additional studies of this technology are needed in larger populations—in particular, at-risk populations such as young children and pregnant mothers.

Blood in bags and vials

Photo by Daniel Gay

A pathogen-reduction system can safely minimize the risk of malaria transmitted via blood transfusion, according to a randomized trial.

The Mirasol pathogen-reduction technology system uses ultraviolet light energy and riboflavin to reduce the pathogen load and inactivate white blood cells in blood products.

In the current study, the system significantly reduced the transmission of malaria-causing Plasmodium parasites in patients receiving whole blood.

“This is the first study to look at the potential of pathogen-reduction technology in a real-world treatment setting and finds that, although the risk of malaria transmission is not completely eliminated, the risk is severely reduced,” said Jean-Pierre Allain, MD, of the University of Cambridge in the UK.

Dr Allain and his colleagues described this research in The Lancet. The work was funded by TerumoBCT Inc., the company developing the Mirasol system.

The trial included 223 adult patients from the Komfo Anokye Teaching Hospital in Kumasi, Ghana, who required a blood transfusion because of severe anemia or hemorrhage and were expected to remain in the hospital for at least 3 consecutive days after the initial transfusion.

The patients were randomized via computer to receive a transfusion with pathogen-reduced whole blood (treated) or whole blood that was prepared and transfused by standard local practice (untreated). Patients, healthcare providers, and data collectors were blinded to the treatment allocation.

The researchers analyzed blood samples for all of the recipients on the day of the transfusion and 1, 3, 7, and 28 days later. By studying the sequences of Plasmodium genes present in the blood, the team was able to tell whether the patients were likely to be carrying the donor parasite after the transfusion.

In all, 214 patients completed the protocol as planned—107 who received treated blood and 107 who received untreated blood.

A total of 65 patients were not previously carrying a Plasmodium parasite but received parasitemic blood. Twenty-eight of these patients received treated blood, and 37 received untreated blood.

The incidence of transfusion-transmitted malaria was significantly lower for the group that received the treated blood. Twenty-two percent of patients (8/37) who received untreated blood later tested positive for the malaria parasite, compared with 4% (1/28) of patients who received treated blood (P=0.039).

The researchers noted that coagulation parameters, platelet counts, and hemostatic status were similar whether patients received treated or untreated blood.

The Mirasol system did not appear to affect the coagulation properties of the blood, and patients who received the treated blood had slightly fewer allergic reactions than those who received the untreated blood (5% vs 8%).

The percentage of patients reporting at least 1 treatment-emergent adverse event (TEAE) was similar between the groups—43% in the treated-blood group and 39% in the untreated-blood group.

Likewise, there were no significant differences between the groups in the incidence of serious TEAEs (12% vs 8%), life-threatening TEAEs (3% for both), hospital admission (5% vs 4%), or death (7% vs 5%). The researchers noted that none of the deaths were related to transfusion or pathogen-reduction technology.

The team said additional studies of this technology are needed in larger populations—in particular, at-risk populations such as young children and pregnant mothers.

Blood for transfusion

Photo courtesy of UAB Hospital

Even a short delay in the administration of packed red blood cells (pRBCs) can increase the risk of death for some traumatically injured patients, according to research published in the Journal of Trauma and Acute Care Surgery.

The study showed that a delay of 10 minutes was associated with a higher risk of death among patients who required pRBCs early.

However, a 10-minute delay did not increase the risk of death for the entire study cohort.

For this study, researchers tracked trauma patients taken from the scene of their injury to the University of Cincinnati Medical Center by a helicopter service known as Air Care. The service carries 2 units of pRBCs for protocol-driven prehospital transfusion.

“Air Care is the only helicopter in the area to carry blood (and plasma), so we had the research platform to study how early blood transfusions impact outcomes,” said study author Elizabeth Powell, MD, of the University of Cincinnati Medical Center in Ohio.

Dr Powell and her colleagues studied 94 patients who had received at least 1 unit of pRBCs within 24 hours of arriving at the hospital. Ninety-three percent of patients (n=87) were Caucasian, 70% (n=66) were male, and they had a mean age of 43.

Ninety-four percent of patients (n=88) had sustained blunt force injuries, and 33% (n=31) died within 30 days of hospital arrival.

Thirty-three percent of patients (n=31) received a transfusion during transport, 54% (n=51) were transfused within an hour of hospital arrival, and 13% (n=12) were transfused after the first hour but within 24 hours of hospital arrival.

When considering all 94 patients together, the researchers found that a 10-minute increase in time to pRBC administration did not significantly affect the odds of death, even when adjusting for injury severity. The odds ratio was 1.00 (P=0.575).

However, among the 82 patients who received their first pRBC transfusion during transport or within an hour of hospital arrival, each 10 minute increase in time to transfusion increased the odds of death. When the researchers controlled for Trauma Injury Severity Score, the odds ratio was 1.27 (P=0.044).

“Delays in the time to blood transfusion are associated with increased chances of dying,” Dr Powell said. “Shortening the time to transfusion, including having blood available in the prehospital setting, may improve outcomes.”

Blood for transfusion

Photo courtesy of UAB Hospital

Even a short delay in the administration of packed red blood cells (pRBCs) can increase the risk of death for some traumatically injured patients, according to research published in the Journal of Trauma and Acute Care Surgery.

The study showed that a delay of 10 minutes was associated with a higher risk of death among patients who required pRBCs early.

However, a 10-minute delay did not increase the risk of death for the entire study cohort.

For this study, researchers tracked trauma patients taken from the scene of their injury to the University of Cincinnati Medical Center by a helicopter service known as Air Care. The service carries 2 units of pRBCs for protocol-driven prehospital transfusion.

“Air Care is the only helicopter in the area to carry blood (and plasma), so we had the research platform to study how early blood transfusions impact outcomes,” said study author Elizabeth Powell, MD, of the University of Cincinnati Medical Center in Ohio.

Dr Powell and her colleagues studied 94 patients who had received at least 1 unit of pRBCs within 24 hours of arriving at the hospital. Ninety-three percent of patients (n=87) were Caucasian, 70% (n=66) were male, and they had a mean age of 43.

Ninety-four percent of patients (n=88) had sustained blunt force injuries, and 33% (n=31) died within 30 days of hospital arrival.

Thirty-three percent of patients (n=31) received a transfusion during transport, 54% (n=51) were transfused within an hour of hospital arrival, and 13% (n=12) were transfused after the first hour but within 24 hours of hospital arrival.

When considering all 94 patients together, the researchers found that a 10-minute increase in time to pRBC administration did not significantly affect the odds of death, even when adjusting for injury severity. The odds ratio was 1.00 (P=0.575).

However, among the 82 patients who received their first pRBC transfusion during transport or within an hour of hospital arrival, each 10 minute increase in time to transfusion increased the odds of death. When the researchers controlled for Trauma Injury Severity Score, the odds ratio was 1.27 (P=0.044).

“Delays in the time to blood transfusion are associated with increased chances of dying,” Dr Powell said. “Shortening the time to transfusion, including having blood available in the prehospital setting, may improve outcomes.”

Blood for transfusion

Photo courtesy of UAB Hospital

Even a short delay in the administration of packed red blood cells (pRBCs) can increase the risk of death for some traumatically injured patients, according to research published in the Journal of Trauma and Acute Care Surgery.

The study showed that a delay of 10 minutes was associated with a higher risk of death among patients who required pRBCs early.

However, a 10-minute delay did not increase the risk of death for the entire study cohort.

For this study, researchers tracked trauma patients taken from the scene of their injury to the University of Cincinnati Medical Center by a helicopter service known as Air Care. The service carries 2 units of pRBCs for protocol-driven prehospital transfusion.

“Air Care is the only helicopter in the area to carry blood (and plasma), so we had the research platform to study how early blood transfusions impact outcomes,” said study author Elizabeth Powell, MD, of the University of Cincinnati Medical Center in Ohio.

Dr Powell and her colleagues studied 94 patients who had received at least 1 unit of pRBCs within 24 hours of arriving at the hospital. Ninety-three percent of patients (n=87) were Caucasian, 70% (n=66) were male, and they had a mean age of 43.

Ninety-four percent of patients (n=88) had sustained blunt force injuries, and 33% (n=31) died within 30 days of hospital arrival.

Thirty-three percent of patients (n=31) received a transfusion during transport, 54% (n=51) were transfused within an hour of hospital arrival, and 13% (n=12) were transfused after the first hour but within 24 hours of hospital arrival.

When considering all 94 patients together, the researchers found that a 10-minute increase in time to pRBC administration did not significantly affect the odds of death, even when adjusting for injury severity. The odds ratio was 1.00 (P=0.575).

However, among the 82 patients who received their first pRBC transfusion during transport or within an hour of hospital arrival, each 10 minute increase in time to transfusion increased the odds of death. When the researchers controlled for Trauma Injury Severity Score, the odds ratio was 1.27 (P=0.044).

“Delays in the time to blood transfusion are associated with increased chances of dying,” Dr Powell said. “Shortening the time to transfusion, including having blood available in the prehospital setting, may improve outcomes.”