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Improving cryopreservation of RBCs
Photo from UAB Hospital
A class of small-molecule ice recrystallization inhibitors could improve the cryopreservation of red blood cells (RBCs) intended for transfusion, according to researchers.
The team said these molecules can decrease the time needed to thaw cryopreserved RBCs, thereby reducing transfusion wait times.
But the molecules also protect RBCs from injury during cryopreservation and reduce the risk of post-thaw hemolysis.
Robert N. Ben, PhD, of the University of Ottawa in Ontario, Canada, and his colleagues conducted this research and detailed the results in the journal ACS Omega.
The researchers began with a class of glucose-based molecules they had previously found to be cryoprotective.
The team set out to determine whether these molecules, known as O-aryl-glycosides, could potentially reduce the time needed to process frozen RBCs.
They found that changes in the structure of O-aryl-glycosides affect their ability to inhibit ice recrystallization and protect against cryoinjury. But 3 O-aryl-glycosides—β-PMP-Glc, β-pBrPh-Glc, and β-pBrPh-Gal—proved particularly effective in these areas.
The researchers said low concentrations of β-PMP-Glc, β-pBrPh-Glc, and β-pBrPh-Gal provided “high post-thaw RBC integrity” and reduced the needed concentration of glycerol from 40% to between 10% and 15%.
The highest post-thaw integrity observed in slow freezing conditions was with β-pBrPh-Glc and β-pBrPh-Gal. The post-thaw integrity was 65% with 55 mM of β-pBrPh-Gal and 67% with 30 mM of β-pBrPh-Glc.
The researchers noted that these molecules were “very effective” in rapid freezing conditions as well. And the addition of glycerol improved post-thaw RBC integrity.
Combining 30 mM of either molecule with 15% glycerol resulted in almost 95% post-thaw RBC integrity, whereas 15% glycerol alone provides 75% post-thaw integrity.
The researchers said 30 mM of β-pBrPh-Glc was even “highly effective” in preventing post-thaw hemolysis with a glycerol concentration of 10%. In this case, the post-thaw integrity was 67%, whereas 10% glycerol alone provides 23% post-thaw integrity.
The researchers noted that lowering the amount of glycerol needed during the cryopreservation process could help minimize the time required to prepare thawed RBCs for transfusion and provide patients with faster access to cryopreserved RBCs.
The team added that O-aryl-glycosides are structurally simple and amenable to large-scale preparation for use in cryopreservation. 
Photo from UAB Hospital
A class of small-molecule ice recrystallization inhibitors could improve the cryopreservation of red blood cells (RBCs) intended for transfusion, according to researchers.
The team said these molecules can decrease the time needed to thaw cryopreserved RBCs, thereby reducing transfusion wait times.
But the molecules also protect RBCs from injury during cryopreservation and reduce the risk of post-thaw hemolysis.
Robert N. Ben, PhD, of the University of Ottawa in Ontario, Canada, and his colleagues conducted this research and detailed the results in the journal ACS Omega.
The researchers began with a class of glucose-based molecules they had previously found to be cryoprotective.
The team set out to determine whether these molecules, known as O-aryl-glycosides, could potentially reduce the time needed to process frozen RBCs.
They found that changes in the structure of O-aryl-glycosides affect their ability to inhibit ice recrystallization and protect against cryoinjury. But 3 O-aryl-glycosides—β-PMP-Glc, β-pBrPh-Glc, and β-pBrPh-Gal—proved particularly effective in these areas.
The researchers said low concentrations of β-PMP-Glc, β-pBrPh-Glc, and β-pBrPh-Gal provided “high post-thaw RBC integrity” and reduced the needed concentration of glycerol from 40% to between 10% and 15%.
The highest post-thaw integrity observed in slow freezing conditions was with β-pBrPh-Glc and β-pBrPh-Gal. The post-thaw integrity was 65% with 55 mM of β-pBrPh-Gal and 67% with 30 mM of β-pBrPh-Glc.
The researchers noted that these molecules were “very effective” in rapid freezing conditions as well. And the addition of glycerol improved post-thaw RBC integrity.
Combining 30 mM of either molecule with 15% glycerol resulted in almost 95% post-thaw RBC integrity, whereas 15% glycerol alone provides 75% post-thaw integrity.
The researchers said 30 mM of β-pBrPh-Glc was even “highly effective” in preventing post-thaw hemolysis with a glycerol concentration of 10%. In this case, the post-thaw integrity was 67%, whereas 10% glycerol alone provides 23% post-thaw integrity.
The researchers noted that lowering the amount of glycerol needed during the cryopreservation process could help minimize the time required to prepare thawed RBCs for transfusion and provide patients with faster access to cryopreserved RBCs.
The team added that O-aryl-glycosides are structurally simple and amenable to large-scale preparation for use in cryopreservation.
Photo from UAB Hospital
A class of small-molecule ice recrystallization inhibitors could improve the cryopreservation of red blood cells (RBCs) intended for transfusion, according to researchers.
The team said these molecules can decrease the time needed to thaw cryopreserved RBCs, thereby reducing transfusion wait times.
But the molecules also protect RBCs from injury during cryopreservation and reduce the risk of post-thaw hemolysis.
Robert N. Ben, PhD, of the University of Ottawa in Ontario, Canada, and his colleagues conducted this research and detailed the results in the journal ACS Omega.
The researchers began with a class of glucose-based molecules they had previously found to be cryoprotective.
The team set out to determine whether these molecules, known as O-aryl-glycosides, could potentially reduce the time needed to process frozen RBCs.
They found that changes in the structure of O-aryl-glycosides affect their ability to inhibit ice recrystallization and protect against cryoinjury. But 3 O-aryl-glycosides—β-PMP-Glc, β-pBrPh-Glc, and β-pBrPh-Gal—proved particularly effective in these areas.
The researchers said low concentrations of β-PMP-Glc, β-pBrPh-Glc, and β-pBrPh-Gal provided “high post-thaw RBC integrity” and reduced the needed concentration of glycerol from 40% to between 10% and 15%.
The highest post-thaw integrity observed in slow freezing conditions was with β-pBrPh-Glc and β-pBrPh-Gal. The post-thaw integrity was 65% with 55 mM of β-pBrPh-Gal and 67% with 30 mM of β-pBrPh-Glc.
The researchers noted that these molecules were “very effective” in rapid freezing conditions as well. And the addition of glycerol improved post-thaw RBC integrity.
Combining 30 mM of either molecule with 15% glycerol resulted in almost 95% post-thaw RBC integrity, whereas 15% glycerol alone provides 75% post-thaw integrity.
The researchers said 30 mM of β-pBrPh-Glc was even “highly effective” in preventing post-thaw hemolysis with a glycerol concentration of 10%. In this case, the post-thaw integrity was 67%, whereas 10% glycerol alone provides 23% post-thaw integrity.
The researchers noted that lowering the amount of glycerol needed during the cryopreservation process could help minimize the time required to prepare thawed RBCs for transfusion and provide patients with faster access to cryopreserved RBCs.
The team added that O-aryl-glycosides are structurally simple and amenable to large-scale preparation for use in cryopreservation.
Treating RBCs with NO may make them safer
Sheep Experiment Station
Research conducted in sheep indicates that pretreating red blood cells (RBCs) with nitric oxide (NO) may make it safer to transfuse blood nearing its expiration date.
Past studies have suggested that RBCs stored for more than 30 days are less likely than “fresher” RBCs to survive after transfusion, and receiving a transfusion of RBCs nearing their expiration date of 42 days may increase the risk of pulmonary hypertension.
However, a new study published in Anesthesiology suggests that pretreating older RBCs with NO may increase their likelihood of survival after transfusion and reduce the risk of pulmonary hypertension in the recipient.
“Extended storage of RBCs makes them rigid and decreases their ability to change shape, which is necessary as they travel through small blood vessels,” said study author Warren M. Zapol, MD, of Massachusetts General Hospital in Boston.
“We found that pretreatment with nitric oxide actually rejuvenates RBCs, making them more flexible so they can more easily travel through blood vessels. This can further reduce the risk of pulmonary hypertension.”
Dr Zapol and his colleagues performed their experiments on RBCs derived from lambs. The team treated RBCs with NO gas, a short-lived NO donor, or gas without NO (control).
The RBCs were then stored for either 2 days (hereafter referred to as “fresh” RBCs) or 40 days (referred to as “stored” RBCs) and transfused back into the original lambs.
RBC survival
The researchers found that treatment with NO gas improved the early post-transfusion survival of stored RBCs.
At 1 hour after transfusion, 75.3 ± 5.8% of the control-treated stored RBCs remained in the circulation, compared to 86.8 ± 8.1% of the NO-treated stored RBCs and 94.2 ± 4.6% of the fresh RBCs.
At 24 hours after transfusion, 73.4 ± 3.8% of the control-treated stored RBCs remained in the circulation, compared to 78.3 ± 6.3% of the NO-treated stored RBCs, 90.8 ± 4.1% of control-treated fresh RBCs, and 91.4 ± 1.4% of NO-treated fresh RBCs.
The differences between stored RBCs that were treated with NO gas and stored control RBCs was statistically significant at both 1 hour and 24 hours, with P values of 0.002 and 0.046, respectively.
Seven days after transfusion, there was no significant difference in the percentage of NO-treated and control-treated RBCs in the circulation.
Pulmonary hypertension
The researchers found that pretreating RBCs with NO prevented transfusion-associated pulmonary hypertension in the lambs.
Lambs that received control-treated stored RBCs had an increase in pulmonary arterial pressure (PAP) during and after transfusion—from 13.4 ± 0.8 mmHg at baseline to a maximum of 22.7 ± 2.2 mmHg.
However, lambs that received stored RBCs treated with NO gas did not have an increase in PAP when compared to lambs that received fresh RBCs.
At 20 minutes, PAP was 14.5 ± 1.4 mmHg for NO-treated stored RBCs, 13.9 ± 0.6 mmHg for control-treated fresh RBCs, and 14 ± 1.2 mmHg for NO-treated fresh RBCs.
The researchers also found that transfusion of stored RBCs caused a transient increase in the pulmonary vascular resistance index (PVRI) from 10 minutes to 30 minutes after transfusion, but pretreatment with NO gas prevented this increase.
At 20 minutes, the PVRI was 211.1 ± 44.4 dyn·sec·cm−5·m−2 for control-treated stored RBCs and 114.6 ± 18.9 dyn·sec·cm−5·m−2 for NO-treated stored RBCs (P<0.0001).
Transfusion of fresh RBCs, with or without prior NO exposure, did not alter the PVRI.
Finally, the researchers found that treating stored RBCs with the NO donor compound MAHMA NONOate prevented transfusion-associated pulmonary hypertension and pulmonary vasoconstriction in awake lambs.
The team said studies with human RBCs are required to confirm the beneficial effects of NO exposure observed in this study.
Sheep Experiment Station
Research conducted in sheep indicates that pretreating red blood cells (RBCs) with nitric oxide (NO) may make it safer to transfuse blood nearing its expiration date.
Past studies have suggested that RBCs stored for more than 30 days are less likely than “fresher” RBCs to survive after transfusion, and receiving a transfusion of RBCs nearing their expiration date of 42 days may increase the risk of pulmonary hypertension.
However, a new study published in Anesthesiology suggests that pretreating older RBCs with NO may increase their likelihood of survival after transfusion and reduce the risk of pulmonary hypertension in the recipient.
“Extended storage of RBCs makes them rigid and decreases their ability to change shape, which is necessary as they travel through small blood vessels,” said study author Warren M. Zapol, MD, of Massachusetts General Hospital in Boston.
“We found that pretreatment with nitric oxide actually rejuvenates RBCs, making them more flexible so they can more easily travel through blood vessels. This can further reduce the risk of pulmonary hypertension.”
Dr Zapol and his colleagues performed their experiments on RBCs derived from lambs. The team treated RBCs with NO gas, a short-lived NO donor, or gas without NO (control).
The RBCs were then stored for either 2 days (hereafter referred to as “fresh” RBCs) or 40 days (referred to as “stored” RBCs) and transfused back into the original lambs.
RBC survival
The researchers found that treatment with NO gas improved the early post-transfusion survival of stored RBCs.
At 1 hour after transfusion, 75.3 ± 5.8% of the control-treated stored RBCs remained in the circulation, compared to 86.8 ± 8.1% of the NO-treated stored RBCs and 94.2 ± 4.6% of the fresh RBCs.
At 24 hours after transfusion, 73.4 ± 3.8% of the control-treated stored RBCs remained in the circulation, compared to 78.3 ± 6.3% of the NO-treated stored RBCs, 90.8 ± 4.1% of control-treated fresh RBCs, and 91.4 ± 1.4% of NO-treated fresh RBCs.
The differences between stored RBCs that were treated with NO gas and stored control RBCs was statistically significant at both 1 hour and 24 hours, with P values of 0.002 and 0.046, respectively.
Seven days after transfusion, there was no significant difference in the percentage of NO-treated and control-treated RBCs in the circulation.
Pulmonary hypertension
The researchers found that pretreating RBCs with NO prevented transfusion-associated pulmonary hypertension in the lambs.
Lambs that received control-treated stored RBCs had an increase in pulmonary arterial pressure (PAP) during and after transfusion—from 13.4 ± 0.8 mmHg at baseline to a maximum of 22.7 ± 2.2 mmHg.
However, lambs that received stored RBCs treated with NO gas did not have an increase in PAP when compared to lambs that received fresh RBCs.
At 20 minutes, PAP was 14.5 ± 1.4 mmHg for NO-treated stored RBCs, 13.9 ± 0.6 mmHg for control-treated fresh RBCs, and 14 ± 1.2 mmHg for NO-treated fresh RBCs.
The researchers also found that transfusion of stored RBCs caused a transient increase in the pulmonary vascular resistance index (PVRI) from 10 minutes to 30 minutes after transfusion, but pretreatment with NO gas prevented this increase.
At 20 minutes, the PVRI was 211.1 ± 44.4 dyn·sec·cm−5·m−2 for control-treated stored RBCs and 114.6 ± 18.9 dyn·sec·cm−5·m−2 for NO-treated stored RBCs (P<0.0001).
Transfusion of fresh RBCs, with or without prior NO exposure, did not alter the PVRI.
Finally, the researchers found that treating stored RBCs with the NO donor compound MAHMA NONOate prevented transfusion-associated pulmonary hypertension and pulmonary vasoconstriction in awake lambs.
The team said studies with human RBCs are required to confirm the beneficial effects of NO exposure observed in this study.
Sheep Experiment Station
Research conducted in sheep indicates that pretreating red blood cells (RBCs) with nitric oxide (NO) may make it safer to transfuse blood nearing its expiration date.
Past studies have suggested that RBCs stored for more than 30 days are less likely than “fresher” RBCs to survive after transfusion, and receiving a transfusion of RBCs nearing their expiration date of 42 days may increase the risk of pulmonary hypertension.
However, a new study published in Anesthesiology suggests that pretreating older RBCs with NO may increase their likelihood of survival after transfusion and reduce the risk of pulmonary hypertension in the recipient.
“Extended storage of RBCs makes them rigid and decreases their ability to change shape, which is necessary as they travel through small blood vessels,” said study author Warren M. Zapol, MD, of Massachusetts General Hospital in Boston.
“We found that pretreatment with nitric oxide actually rejuvenates RBCs, making them more flexible so they can more easily travel through blood vessels. This can further reduce the risk of pulmonary hypertension.”
Dr Zapol and his colleagues performed their experiments on RBCs derived from lambs. The team treated RBCs with NO gas, a short-lived NO donor, or gas without NO (control).
The RBCs were then stored for either 2 days (hereafter referred to as “fresh” RBCs) or 40 days (referred to as “stored” RBCs) and transfused back into the original lambs.
RBC survival
The researchers found that treatment with NO gas improved the early post-transfusion survival of stored RBCs.
At 1 hour after transfusion, 75.3 ± 5.8% of the control-treated stored RBCs remained in the circulation, compared to 86.8 ± 8.1% of the NO-treated stored RBCs and 94.2 ± 4.6% of the fresh RBCs.
At 24 hours after transfusion, 73.4 ± 3.8% of the control-treated stored RBCs remained in the circulation, compared to 78.3 ± 6.3% of the NO-treated stored RBCs, 90.8 ± 4.1% of control-treated fresh RBCs, and 91.4 ± 1.4% of NO-treated fresh RBCs.
The differences between stored RBCs that were treated with NO gas and stored control RBCs was statistically significant at both 1 hour and 24 hours, with P values of 0.002 and 0.046, respectively.
Seven days after transfusion, there was no significant difference in the percentage of NO-treated and control-treated RBCs in the circulation.
Pulmonary hypertension
The researchers found that pretreating RBCs with NO prevented transfusion-associated pulmonary hypertension in the lambs.
Lambs that received control-treated stored RBCs had an increase in pulmonary arterial pressure (PAP) during and after transfusion—from 13.4 ± 0.8 mmHg at baseline to a maximum of 22.7 ± 2.2 mmHg.
However, lambs that received stored RBCs treated with NO gas did not have an increase in PAP when compared to lambs that received fresh RBCs.
At 20 minutes, PAP was 14.5 ± 1.4 mmHg for NO-treated stored RBCs, 13.9 ± 0.6 mmHg for control-treated fresh RBCs, and 14 ± 1.2 mmHg for NO-treated fresh RBCs.
The researchers also found that transfusion of stored RBCs caused a transient increase in the pulmonary vascular resistance index (PVRI) from 10 minutes to 30 minutes after transfusion, but pretreatment with NO gas prevented this increase.
At 20 minutes, the PVRI was 211.1 ± 44.4 dyn·sec·cm−5·m−2 for control-treated stored RBCs and 114.6 ± 18.9 dyn·sec·cm−5·m−2 for NO-treated stored RBCs (P<0.0001).
Transfusion of fresh RBCs, with or without prior NO exposure, did not alter the PVRI.
Finally, the researchers found that treating stored RBCs with the NO donor compound MAHMA NONOate prevented transfusion-associated pulmonary hypertension and pulmonary vasoconstriction in awake lambs.
The team said studies with human RBCs are required to confirm the beneficial effects of NO exposure observed in this study.
Tranexamic acid safely reduces need for transfusion, study suggests
Photo by Piotr Bodzek
Results of a large study suggest that tranexamic acid can reduce the need for blood transfusion without increasing the risk of thrombotic complications or death in patients undergoing coronary artery surgery.
Patients who received tranexamic acid had a lower risk of excessive bleeding, required fewer units of blood products, and had a lower risk of emergency reoperation after surgery than patients who received placebo.
In addition, patients who received tranexamic acid had no higher risk of death or thrombotic complications than those who received placebo.
Paul S. Myles, MBBS, MD, of Alfred Hospital in Melbourne, Australia, and his colleagues conducted this study and reported the results in NEJM. The study was also presented at the ANESTHESIOLOGY® 2016 annual meeting.
The study included 4631 patients who underwent surgery and had available outcomes data, 2311 who were assigned to receive tranexamic acid and 2320 who were assigned to receive placebo.
The study’s primary outcome was a composite of death and thrombotic complications (nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.
There was no significant difference in the primary outcome between the 2 treatment groups. Thrombotic complications/death occurred in 16.7% of patients in the tranexamic acid group and 18.1% in the placebo group (relative risk=0.92; P=0.22).
Patients who received placebo required significantly more units of blood products than patients who received tranexamic acid—7994 and 4331 units, respectively (P<0.001).
And significantly fewer patients in the tranexamic acid group than the placebo group had major hemorrhage or cardiac tamponade leading to emergency reoperations—1.4% and 2.8%, respectively (P=0.001).
However, patients in the tranexamic group had a significantly higher incidence of seizures—0.7% and 0.1%, respectively (P=0.002).
Dr Myles said that although this study was conducted in patients undergoing coronary artery surgery, the results are relevant for patients having many other types of surgery where bleeding and the need for blood transfusion may occur.
Photo by Piotr Bodzek
Results of a large study suggest that tranexamic acid can reduce the need for blood transfusion without increasing the risk of thrombotic complications or death in patients undergoing coronary artery surgery.
Patients who received tranexamic acid had a lower risk of excessive bleeding, required fewer units of blood products, and had a lower risk of emergency reoperation after surgery than patients who received placebo.
In addition, patients who received tranexamic acid had no higher risk of death or thrombotic complications than those who received placebo.
Paul S. Myles, MBBS, MD, of Alfred Hospital in Melbourne, Australia, and his colleagues conducted this study and reported the results in NEJM. The study was also presented at the ANESTHESIOLOGY® 2016 annual meeting.
The study included 4631 patients who underwent surgery and had available outcomes data, 2311 who were assigned to receive tranexamic acid and 2320 who were assigned to receive placebo.
The study’s primary outcome was a composite of death and thrombotic complications (nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.
There was no significant difference in the primary outcome between the 2 treatment groups. Thrombotic complications/death occurred in 16.7% of patients in the tranexamic acid group and 18.1% in the placebo group (relative risk=0.92; P=0.22).
Patients who received placebo required significantly more units of blood products than patients who received tranexamic acid—7994 and 4331 units, respectively (P<0.001).
And significantly fewer patients in the tranexamic acid group than the placebo group had major hemorrhage or cardiac tamponade leading to emergency reoperations—1.4% and 2.8%, respectively (P=0.001).
However, patients in the tranexamic group had a significantly higher incidence of seizures—0.7% and 0.1%, respectively (P=0.002).
Dr Myles said that although this study was conducted in patients undergoing coronary artery surgery, the results are relevant for patients having many other types of surgery where bleeding and the need for blood transfusion may occur.
Photo by Piotr Bodzek
Results of a large study suggest that tranexamic acid can reduce the need for blood transfusion without increasing the risk of thrombotic complications or death in patients undergoing coronary artery surgery.
Patients who received tranexamic acid had a lower risk of excessive bleeding, required fewer units of blood products, and had a lower risk of emergency reoperation after surgery than patients who received placebo.
In addition, patients who received tranexamic acid had no higher risk of death or thrombotic complications than those who received placebo.
Paul S. Myles, MBBS, MD, of Alfred Hospital in Melbourne, Australia, and his colleagues conducted this study and reported the results in NEJM. The study was also presented at the ANESTHESIOLOGY® 2016 annual meeting.
The study included 4631 patients who underwent surgery and had available outcomes data, 2311 who were assigned to receive tranexamic acid and 2320 who were assigned to receive placebo.
The study’s primary outcome was a composite of death and thrombotic complications (nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.
There was no significant difference in the primary outcome between the 2 treatment groups. Thrombotic complications/death occurred in 16.7% of patients in the tranexamic acid group and 18.1% in the placebo group (relative risk=0.92; P=0.22).
Patients who received placebo required significantly more units of blood products than patients who received tranexamic acid—7994 and 4331 units, respectively (P<0.001).
And significantly fewer patients in the tranexamic acid group than the placebo group had major hemorrhage or cardiac tamponade leading to emergency reoperations—1.4% and 2.8%, respectively (P=0.001).
However, patients in the tranexamic group had a significantly higher incidence of seizures—0.7% and 0.1%, respectively (P=0.002).
Dr Myles said that although this study was conducted in patients undergoing coronary artery surgery, the results are relevant for patients having many other types of surgery where bleeding and the need for blood transfusion may occur.
FDA approves blood screening assay
Photo by Daniel Gay
The US Food and Drug Administration has approved the blood screening assay cobas® MPX for use on the cobas® 6800 and 8800 Systems.
cobas® MPX is a nucleic acid test designed to screen donated blood and plasma for human immunodeficiency virus (HIV),hepatitis B virus (HBV), and hepatitis C virus (HCV).
The test can detect 5 viral targets—HIV-1 Group M, HIV-1 Group O, HIV-2, HBV, and HCV—in a single sample.
cobas® MPX features a dual-target approach with amplification of separate regions of HIV-1 and dual probes for HCV. It eliminates both the need for discriminatory testing between HIV, HBV, and HCV and the potential for discrepant results.
cobas® MPX is a product of Roche Molecular Diagnostics and can be used on Roche’s cobas® 6800 System or cobas® 8800 System.
These systems are used for routine molecular testing in the areas of donor screening, viral load monitoring, women’s health, and microbiology.
Both systems make it possible for labs to perform up to 3 tests in the same run with no pre-sorting required.
In an 8-hour shift, the cobas® 6800 System can provide 384 results, and the cobas® 8800 System can provide 960 results.
The cobas® 6800 system enables up to 8 hours of walk-away time with minimal user interaction, and the cobas® 8800 enables up to 4 hours of walk-away time.
Photo by Daniel Gay
The US Food and Drug Administration has approved the blood screening assay cobas® MPX for use on the cobas® 6800 and 8800 Systems.
cobas® MPX is a nucleic acid test designed to screen donated blood and plasma for human immunodeficiency virus (HIV),hepatitis B virus (HBV), and hepatitis C virus (HCV).
The test can detect 5 viral targets—HIV-1 Group M, HIV-1 Group O, HIV-2, HBV, and HCV—in a single sample.
cobas® MPX features a dual-target approach with amplification of separate regions of HIV-1 and dual probes for HCV. It eliminates both the need for discriminatory testing between HIV, HBV, and HCV and the potential for discrepant results.
cobas® MPX is a product of Roche Molecular Diagnostics and can be used on Roche’s cobas® 6800 System or cobas® 8800 System.
These systems are used for routine molecular testing in the areas of donor screening, viral load monitoring, women’s health, and microbiology.
Both systems make it possible for labs to perform up to 3 tests in the same run with no pre-sorting required.
In an 8-hour shift, the cobas® 6800 System can provide 384 results, and the cobas® 8800 System can provide 960 results.
The cobas® 6800 system enables up to 8 hours of walk-away time with minimal user interaction, and the cobas® 8800 enables up to 4 hours of walk-away time.
Photo by Daniel Gay
The US Food and Drug Administration has approved the blood screening assay cobas® MPX for use on the cobas® 6800 and 8800 Systems.
cobas® MPX is a nucleic acid test designed to screen donated blood and plasma for human immunodeficiency virus (HIV),hepatitis B virus (HBV), and hepatitis C virus (HCV).
The test can detect 5 viral targets—HIV-1 Group M, HIV-1 Group O, HIV-2, HBV, and HCV—in a single sample.
cobas® MPX features a dual-target approach with amplification of separate regions of HIV-1 and dual probes for HCV. It eliminates both the need for discriminatory testing between HIV, HBV, and HCV and the potential for discrepant results.
cobas® MPX is a product of Roche Molecular Diagnostics and can be used on Roche’s cobas® 6800 System or cobas® 8800 System.
These systems are used for routine molecular testing in the areas of donor screening, viral load monitoring, women’s health, and microbiology.
Both systems make it possible for labs to perform up to 3 tests in the same run with no pre-sorting required.
In an 8-hour shift, the cobas® 6800 System can provide 384 results, and the cobas® 8800 System can provide 960 results.
The cobas® 6800 system enables up to 8 hours of walk-away time with minimal user interaction, and the cobas® 8800 enables up to 4 hours of walk-away time.
Test approved to screen donated blood for sickle cell trait
The US Food and Drug Administration (FDA) has approved use of the PreciseType HEA test to screen blood donors for sickle cell trait (SCT).
The test was previously FDA approved for use in determining blood compatibility between donors and transfusion recipients.
The added utility of screening donors for SCT addresses the desire to avoid transfusing red blood cells from SCT donors to neonates or patients with sickle cell disease.
Blood from SCT donors can also present a problem when performing the required filtration of white cells from the blood donation.
The PreciseType HEA test will allow these units to be identified prior to filtration and provide blood center staff with the opportunity to decide how best to utilize the various components of a whole blood donation.
The PreciseType HEA test is manufactured by BioArray Solutions, a wholly owned subsidiary of Immucor, Inc.
“We’ve successfully demonstrated the clinical benefits of our PreciseType HEA test, and this is evident in the FDA broadening its approved use,” said Michael Spigarelli, vice president of medical affairs at Immucor.
“The use of PreciseType HEA to screen donor units for patients with sickle cell disease, neonates, or any individual that may require SCT-negative blood provides a great improvement over previously used methods and offers the first FDA-approved molecular method specifically for screening units.”
SCT screening has traditionally been performed by solubility testing of sickle hemoglobin in buffer, but blood centers have been looking for an alternative due to limitations in this method.
According to Immucor, a molecular approach using PreciseType HEA can overcome the throughput limitations and reduce the false-positive rates observed with the traditional SCT screening method.
“We had already validated the PreciseType HEA test for [SCT screening] in our lab,” said Connie Westhoff, PhD, of the New York Blood Center in New York, New York.
“Our previous screening method required manual testing and interpretation of the results and had high false-positive rates. About 1 in 12 minority donors possess the sickle trait, so accurate results are important to us to avoid unnecessary notifications to donors and deferred blood units. We are now able to identify SCT in our donors utilizing the same PreciseType HEA test we are already running on many of our donors without running additional tests.”
The US Food and Drug Administration (FDA) has approved use of the PreciseType HEA test to screen blood donors for sickle cell trait (SCT).
The test was previously FDA approved for use in determining blood compatibility between donors and transfusion recipients.
The added utility of screening donors for SCT addresses the desire to avoid transfusing red blood cells from SCT donors to neonates or patients with sickle cell disease.
Blood from SCT donors can also present a problem when performing the required filtration of white cells from the blood donation.
The PreciseType HEA test will allow these units to be identified prior to filtration and provide blood center staff with the opportunity to decide how best to utilize the various components of a whole blood donation.
The PreciseType HEA test is manufactured by BioArray Solutions, a wholly owned subsidiary of Immucor, Inc.
“We’ve successfully demonstrated the clinical benefits of our PreciseType HEA test, and this is evident in the FDA broadening its approved use,” said Michael Spigarelli, vice president of medical affairs at Immucor.
“The use of PreciseType HEA to screen donor units for patients with sickle cell disease, neonates, or any individual that may require SCT-negative blood provides a great improvement over previously used methods and offers the first FDA-approved molecular method specifically for screening units.”
SCT screening has traditionally been performed by solubility testing of sickle hemoglobin in buffer, but blood centers have been looking for an alternative due to limitations in this method.
According to Immucor, a molecular approach using PreciseType HEA can overcome the throughput limitations and reduce the false-positive rates observed with the traditional SCT screening method.
“We had already validated the PreciseType HEA test for [SCT screening] in our lab,” said Connie Westhoff, PhD, of the New York Blood Center in New York, New York.
“Our previous screening method required manual testing and interpretation of the results and had high false-positive rates. About 1 in 12 minority donors possess the sickle trait, so accurate results are important to us to avoid unnecessary notifications to donors and deferred blood units. We are now able to identify SCT in our donors utilizing the same PreciseType HEA test we are already running on many of our donors without running additional tests.”
The US Food and Drug Administration (FDA) has approved use of the PreciseType HEA test to screen blood donors for sickle cell trait (SCT).
The test was previously FDA approved for use in determining blood compatibility between donors and transfusion recipients.
The added utility of screening donors for SCT addresses the desire to avoid transfusing red blood cells from SCT donors to neonates or patients with sickle cell disease.
Blood from SCT donors can also present a problem when performing the required filtration of white cells from the blood donation.
The PreciseType HEA test will allow these units to be identified prior to filtration and provide blood center staff with the opportunity to decide how best to utilize the various components of a whole blood donation.
The PreciseType HEA test is manufactured by BioArray Solutions, a wholly owned subsidiary of Immucor, Inc.
“We’ve successfully demonstrated the clinical benefits of our PreciseType HEA test, and this is evident in the FDA broadening its approved use,” said Michael Spigarelli, vice president of medical affairs at Immucor.
“The use of PreciseType HEA to screen donor units for patients with sickle cell disease, neonates, or any individual that may require SCT-negative blood provides a great improvement over previously used methods and offers the first FDA-approved molecular method specifically for screening units.”
SCT screening has traditionally been performed by solubility testing of sickle hemoglobin in buffer, but blood centers have been looking for an alternative due to limitations in this method.
According to Immucor, a molecular approach using PreciseType HEA can overcome the throughput limitations and reduce the false-positive rates observed with the traditional SCT screening method.
“We had already validated the PreciseType HEA test for [SCT screening] in our lab,” said Connie Westhoff, PhD, of the New York Blood Center in New York, New York.
“Our previous screening method required manual testing and interpretation of the results and had high false-positive rates. About 1 in 12 minority donors possess the sickle trait, so accurate results are important to us to avoid unnecessary notifications to donors and deferred blood units. We are now able to identify SCT in our donors utilizing the same PreciseType HEA test we are already running on many of our donors without running additional tests.”
FDA clears analyzer for high-volume transfusion labs
Photo courtesy of
PR Newswire and
Ortho Clinical Diagnostics
The US Food and Drug Administration has granted 510(k) clearance for ORTHO VISION® Max, a fully automated blood analyzer for high-volume transfusion medicine laboratories.
Ortho Clinical Diagnostics developed ORTHO VISION Max for labs conducting more than 50 types and screens per day.
ORTHO VISION Max is now commercially available in the US as well as Europe and Japan.
The launch of ORTHO VISION® Max follows the 2015 release of the ORTHO VISION® Analyzer, an instrument designed for small- to mid-sized transfusion labs.
Together, the analyzers form the ORTHO VISION® platform. According to Ortho Clinical Diagnostics, the platform automates more tests than ever before and takes less time to perform those tests.
The platform supports complex immunohematology testing such as serial dilutions for titration studies, reflex tests, and selected cell antibody identification.
The ORTHO VISION platform also has scheduling intelligence, which allows a transfusion medicine department to process routine samples and STAT orders as they are received, rather than waiting for a complete batch before running the instrument.
The platform offers dynamic workflow and lab standardization across instrumentation, technology, procedures, and training. These features are intended to help blood bank labs keep pace with growing industry pressure to increase productivity while remaining operationally efficient.
“Labs are continuously pushed to accomplish more with fewer resources, including staff, and Ortho can now ease those pressures in labs of every size and makeup,” said Robert Yates, chief operating officer of Ortho Clinical Diagnostics.
“Whether they perform 15 tests per day or 150, the ORTHO VISION platform helps labs better manage their contribution to the overall critical care path.”
Photo courtesy of
PR Newswire and
Ortho Clinical Diagnostics
The US Food and Drug Administration has granted 510(k) clearance for ORTHO VISION® Max, a fully automated blood analyzer for high-volume transfusion medicine laboratories.
Ortho Clinical Diagnostics developed ORTHO VISION Max for labs conducting more than 50 types and screens per day.
ORTHO VISION Max is now commercially available in the US as well as Europe and Japan.
The launch of ORTHO VISION® Max follows the 2015 release of the ORTHO VISION® Analyzer, an instrument designed for small- to mid-sized transfusion labs.
Together, the analyzers form the ORTHO VISION® platform. According to Ortho Clinical Diagnostics, the platform automates more tests than ever before and takes less time to perform those tests.
The platform supports complex immunohematology testing such as serial dilutions for titration studies, reflex tests, and selected cell antibody identification.
The ORTHO VISION platform also has scheduling intelligence, which allows a transfusion medicine department to process routine samples and STAT orders as they are received, rather than waiting for a complete batch before running the instrument.
The platform offers dynamic workflow and lab standardization across instrumentation, technology, procedures, and training. These features are intended to help blood bank labs keep pace with growing industry pressure to increase productivity while remaining operationally efficient.
“Labs are continuously pushed to accomplish more with fewer resources, including staff, and Ortho can now ease those pressures in labs of every size and makeup,” said Robert Yates, chief operating officer of Ortho Clinical Diagnostics.
“Whether they perform 15 tests per day or 150, the ORTHO VISION platform helps labs better manage their contribution to the overall critical care path.”
Photo courtesy of
PR Newswire and
Ortho Clinical Diagnostics
The US Food and Drug Administration has granted 510(k) clearance for ORTHO VISION® Max, a fully automated blood analyzer for high-volume transfusion medicine laboratories.
Ortho Clinical Diagnostics developed ORTHO VISION Max for labs conducting more than 50 types and screens per day.
ORTHO VISION Max is now commercially available in the US as well as Europe and Japan.
The launch of ORTHO VISION® Max follows the 2015 release of the ORTHO VISION® Analyzer, an instrument designed for small- to mid-sized transfusion labs.
Together, the analyzers form the ORTHO VISION® platform. According to Ortho Clinical Diagnostics, the platform automates more tests than ever before and takes less time to perform those tests.
The platform supports complex immunohematology testing such as serial dilutions for titration studies, reflex tests, and selected cell antibody identification.
The ORTHO VISION platform also has scheduling intelligence, which allows a transfusion medicine department to process routine samples and STAT orders as they are received, rather than waiting for a complete batch before running the instrument.
The platform offers dynamic workflow and lab standardization across instrumentation, technology, procedures, and training. These features are intended to help blood bank labs keep pace with growing industry pressure to increase productivity while remaining operationally efficient.
“Labs are continuously pushed to accomplish more with fewer resources, including staff, and Ortho can now ease those pressures in labs of every size and makeup,” said Robert Yates, chief operating officer of Ortho Clinical Diagnostics.
“Whether they perform 15 tests per day or 150, the ORTHO VISION platform helps labs better manage their contribution to the overall critical care path.”
Age of blood doesn’t affect risk of death, study shows
Photo by Elise Amendola
Results of a large, international study suggest the risk of death after transfusion is not significantly affected by the age of blood transfused.
The median storage duration for the fresher blood used in this study was 11 days, and the median storage duration for older blood was 23 days.
The rate of death was 9.1% for the patients who received fresher blood and 8.8% for patients who received older blood (P=0.38).
Researchers reported these and other results from this study in NEJM.
“It’s been a contentious issue, but our study finally puts an end to the question about whether stored blood could be harmful and fresher blood would be better,” said study author Nancy Heddle, of McMaster University in Hamilton, Ontario, Canada.
“Our study provides strong evidence that transfusion of fresh blood does not improve patient outcomes, and this should reassure clinicians that fresher is not better.”
For this study, Heddle and her colleagues enrolled 31,497 adult patients treated at hospitals in Australia, Canada, Israel, and the US. However, 6761 patients did not meet all the enrollment criteria and were excluded after randomization.
A and O blood types
The researchers’ primary analysis included only patients with type A or O blood. Of these 20,858 patients, 6936 were assigned to receive blood stored for a shorter period, and 13,922 were assigned to receive blood stored for a longer period.
The mean storage duration was 13.0 ± 7.6 days in the short-term group and 23.6 ± 8.9 days in the long-term group. The median storage duration was 11 days (range, 8-16) and 23 days (range, 16-31), respectively.
The rate of death was 9.1% (n=634) in the short-term storage group and 8.7% (n=1213) in the long-term storage group. The odds ratio was 1.05 (95% CI, 0.95 to 1.16; P=0.34).
All blood types
The researchers also analyzed patients with any blood type. Of the 24,736 patients studied, 8215 were assigned to receive blood stored for a shorter period, and 16,521 were assigned to receive blood stored for a longer period.
The mean storage duration was 13.4 ± 7.7 days in the short-term group and 23.6 ± 8.9 days in the long-term group. The median storage duration was 11 days (range, 8-17) and 23 days (range, 16-31), respectively.
The rate of death was 9.1% (n=750) in the short-term storage group and 8.8% (n=1446) in the long-term storage group. The odds ratio was 1.04 (95% CI, 0.95 to 1.14; P=0.38).
The researchers said the overall results were similar to those observed in 3 pre-specified high-risk subgroups—patients undergoing cardiovascular surgery, individuals admitted to intensive care, and patients with cancer.
“Advances in blood storage now allow blood to be stored up to 42 days before transfusion, and the usual practice is to use up the blood that has been in storage the longest,” said study author John Eikelboom, MD, also of McMaster University.
“But because there are biochemical, structural, and functional changes in the blood during storage, there had been concerns about the use of ‘older’ blood. This study reassures us that aging is not bad—even for blood.”
The findings of this study are in line with the recently released AABB recommendations on blood transfusion.
Photo by Elise Amendola
Results of a large, international study suggest the risk of death after transfusion is not significantly affected by the age of blood transfused.
The median storage duration for the fresher blood used in this study was 11 days, and the median storage duration for older blood was 23 days.
The rate of death was 9.1% for the patients who received fresher blood and 8.8% for patients who received older blood (P=0.38).
Researchers reported these and other results from this study in NEJM.
“It’s been a contentious issue, but our study finally puts an end to the question about whether stored blood could be harmful and fresher blood would be better,” said study author Nancy Heddle, of McMaster University in Hamilton, Ontario, Canada.
“Our study provides strong evidence that transfusion of fresh blood does not improve patient outcomes, and this should reassure clinicians that fresher is not better.”
For this study, Heddle and her colleagues enrolled 31,497 adult patients treated at hospitals in Australia, Canada, Israel, and the US. However, 6761 patients did not meet all the enrollment criteria and were excluded after randomization.
A and O blood types
The researchers’ primary analysis included only patients with type A or O blood. Of these 20,858 patients, 6936 were assigned to receive blood stored for a shorter period, and 13,922 were assigned to receive blood stored for a longer period.
The mean storage duration was 13.0 ± 7.6 days in the short-term group and 23.6 ± 8.9 days in the long-term group. The median storage duration was 11 days (range, 8-16) and 23 days (range, 16-31), respectively.
The rate of death was 9.1% (n=634) in the short-term storage group and 8.7% (n=1213) in the long-term storage group. The odds ratio was 1.05 (95% CI, 0.95 to 1.16; P=0.34).
All blood types
The researchers also analyzed patients with any blood type. Of the 24,736 patients studied, 8215 were assigned to receive blood stored for a shorter period, and 16,521 were assigned to receive blood stored for a longer period.
The mean storage duration was 13.4 ± 7.7 days in the short-term group and 23.6 ± 8.9 days in the long-term group. The median storage duration was 11 days (range, 8-17) and 23 days (range, 16-31), respectively.
The rate of death was 9.1% (n=750) in the short-term storage group and 8.8% (n=1446) in the long-term storage group. The odds ratio was 1.04 (95% CI, 0.95 to 1.14; P=0.38).
The researchers said the overall results were similar to those observed in 3 pre-specified high-risk subgroups—patients undergoing cardiovascular surgery, individuals admitted to intensive care, and patients with cancer.
“Advances in blood storage now allow blood to be stored up to 42 days before transfusion, and the usual practice is to use up the blood that has been in storage the longest,” said study author John Eikelboom, MD, also of McMaster University.
“But because there are biochemical, structural, and functional changes in the blood during storage, there had been concerns about the use of ‘older’ blood. This study reassures us that aging is not bad—even for blood.”
The findings of this study are in line with the recently released AABB recommendations on blood transfusion.
Photo by Elise Amendola
Results of a large, international study suggest the risk of death after transfusion is not significantly affected by the age of blood transfused.
The median storage duration for the fresher blood used in this study was 11 days, and the median storage duration for older blood was 23 days.
The rate of death was 9.1% for the patients who received fresher blood and 8.8% for patients who received older blood (P=0.38).
Researchers reported these and other results from this study in NEJM.
“It’s been a contentious issue, but our study finally puts an end to the question about whether stored blood could be harmful and fresher blood would be better,” said study author Nancy Heddle, of McMaster University in Hamilton, Ontario, Canada.
“Our study provides strong evidence that transfusion of fresh blood does not improve patient outcomes, and this should reassure clinicians that fresher is not better.”
For this study, Heddle and her colleagues enrolled 31,497 adult patients treated at hospitals in Australia, Canada, Israel, and the US. However, 6761 patients did not meet all the enrollment criteria and were excluded after randomization.
A and O blood types
The researchers’ primary analysis included only patients with type A or O blood. Of these 20,858 patients, 6936 were assigned to receive blood stored for a shorter period, and 13,922 were assigned to receive blood stored for a longer period.
The mean storage duration was 13.0 ± 7.6 days in the short-term group and 23.6 ± 8.9 days in the long-term group. The median storage duration was 11 days (range, 8-16) and 23 days (range, 16-31), respectively.
The rate of death was 9.1% (n=634) in the short-term storage group and 8.7% (n=1213) in the long-term storage group. The odds ratio was 1.05 (95% CI, 0.95 to 1.16; P=0.34).
All blood types
The researchers also analyzed patients with any blood type. Of the 24,736 patients studied, 8215 were assigned to receive blood stored for a shorter period, and 16,521 were assigned to receive blood stored for a longer period.
The mean storage duration was 13.4 ± 7.7 days in the short-term group and 23.6 ± 8.9 days in the long-term group. The median storage duration was 11 days (range, 8-17) and 23 days (range, 16-31), respectively.
The rate of death was 9.1% (n=750) in the short-term storage group and 8.8% (n=1446) in the long-term storage group. The odds ratio was 1.04 (95% CI, 0.95 to 1.14; P=0.38).
The researchers said the overall results were similar to those observed in 3 pre-specified high-risk subgroups—patients undergoing cardiovascular surgery, individuals admitted to intensive care, and patients with cancer.
“Advances in blood storage now allow blood to be stored up to 42 days before transfusion, and the usual practice is to use up the blood that has been in storage the longest,” said study author John Eikelboom, MD, also of McMaster University.
“But because there are biochemical, structural, and functional changes in the blood during storage, there had been concerns about the use of ‘older’ blood. This study reassures us that aging is not bad—even for blood.”
The findings of this study are in line with the recently released AABB recommendations on blood transfusion.
‘Fresher’ RBCs no safer than standard RBCs, AABB says
Photo courtesy of UAB Hospital
AABB has released new guidelines on when to perform red blood cell (RBC) transfusions and the optimal duration of RBC storage.
The guidelines state that a restrictive transfusion threshold—waiting to transfuse until a patient’s hemoglobin level is 7-8 g/dL—is safe in most clinical settings.
And, for most patients, “fresh” RBCs—stored for less than 10 days—are no safer than standard-issue RBCs—stored for up to 42 days.
“One of the biggest controversies concerning transfusion therapy is whether older blood is harmful compared to fresher blood,” said guideline author Aaron Tobian, MD, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.
“Now, we have information that can accurately inform guidelines about red blood cell storage duration. If data suggest no harm from the use of standard-issue blood and fresher blood would only constrain the use of a limited resource, continuing with standard practice of using older blood is appropriate. The newly released guidelines now clearly inform the community.”
The guidelines were published in JAMA alongside a related editorial.
The recommendations in the guidelines are based on an analysis of randomized clinical trials in which researchers evaluated hemoglobin thresholds for RBC transfusion (trials conducted from 1950 through May 2016) and RBC storage duration (trials conducted from 1948 through May 2016).
For transfusion thresholds, there were 31 trials including 12,587 subjects. The results of these trials suggested that restrictive transfusion thresholds (transfusing when the hemoglobin level is 7-8 g/dL) were not associated with higher rates of adverse clinical outcomes when compared to liberal thresholds (transfusing when the hemoglobin level is 9-10 g/dL).
For RBC storage duration, there were 13 trials including 5515 subjects. The results suggested that transfusing fresher blood did not improve clinical outcomes.
Transfusion threshold
The guideline authors said it is good practice, when making transfusion decisions, to consider the patient’s hemoglobin level, the overall clinical context, patient preference, and alternative therapies.
However, in general, a hemoglobin level of 7 g/dL should serve as the threshold for transfusing adult patients who are hemodynamically stable, even if they are in critical care. This is a strong recommendation based on moderate-quality evidence.
“While the recommended threshold of 7 g/dL is consistent with previous AABB guidelines, the strength of the new recommendation reflects the quality and quantity of the new data, much of which was generated since 2012,” said guideline author Jeffrey Carson, MD, of Robert Wood Johnson University Hospital in New Brunswick, New Jersey.
“Clinically, these results show that no harm will come from waiting to transfuse a patient until the hemoglobin level reaches a lower point. The restrictive approach is associated with reductions in blood use, blood conservation, and lower expenses.”
The guidelines also state that, for patients with pre-existing cardiovascular disease and those undergoing cardiac or orthopedic surgery, the threshold should be 8 g/dL. This is a strong recommendation based on moderate-quality evidence.
Neither of the aforementioned recommendations apply to patients with acute coronary syndrome, severe thrombocytopenia, or chronic transfusion-dependent anemia.
Dr Carson said additional trials are needed to determine whether these patients benefit from transfusion at higher hemoglobin levels.
“We are about to embark on a large, international clinical trial supported by the NIH [National Institutes of Health] that will provide the evidence needed to determine the best course of action for patients who have had a heart attack,” he said.
Dr Carson and his colleagues also noted that, although the recommendations are based on the available evidence, the hemoglobin transfusion thresholds assessed may not be optimal. And the use of hemoglobin transfusion thresholds may be an imperfect surrogate for oxygen delivery.
Storage duration
The guidelines state that most patients, including neonates, should receive standard-issue RBCs (stored for 42 days or less) rather than limiting patients to only fresh RBCs (stored for less than 10 days). This is a strong recommendation based on moderate-quality evidence.
The trials analyzed showed that patients who received standard-issue RBCs faced no higher risk of complications—including 30-day mortality, myocardial infarction, cerebrovascular accident, rebleeding, pneumonia, or thromboembolism—than those who received fresh RBCs.
However, the guideline authors said the trial results may not apply to RBCs nearing their expiration date (stored for 35 to 42 days), as only a small proportion of patients in these trials were exposed to such RBCs.
Furthermore, the trials did not include patients undergoing a massive or exchange transfusion, neonates and children with underlying renal disease at higher risk of hyperkalemia, patients undergoing intrauterine transfusions, or patients with hemoglobinopathies requiring chronic transfusion support.
So the optimal RBC storage duration for these patients is unknown.
Photo courtesy of UAB Hospital
AABB has released new guidelines on when to perform red blood cell (RBC) transfusions and the optimal duration of RBC storage.
The guidelines state that a restrictive transfusion threshold—waiting to transfuse until a patient’s hemoglobin level is 7-8 g/dL—is safe in most clinical settings.
And, for most patients, “fresh” RBCs—stored for less than 10 days—are no safer than standard-issue RBCs—stored for up to 42 days.
“One of the biggest controversies concerning transfusion therapy is whether older blood is harmful compared to fresher blood,” said guideline author Aaron Tobian, MD, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.
“Now, we have information that can accurately inform guidelines about red blood cell storage duration. If data suggest no harm from the use of standard-issue blood and fresher blood would only constrain the use of a limited resource, continuing with standard practice of using older blood is appropriate. The newly released guidelines now clearly inform the community.”
The guidelines were published in JAMA alongside a related editorial.
The recommendations in the guidelines are based on an analysis of randomized clinical trials in which researchers evaluated hemoglobin thresholds for RBC transfusion (trials conducted from 1950 through May 2016) and RBC storage duration (trials conducted from 1948 through May 2016).
For transfusion thresholds, there were 31 trials including 12,587 subjects. The results of these trials suggested that restrictive transfusion thresholds (transfusing when the hemoglobin level is 7-8 g/dL) were not associated with higher rates of adverse clinical outcomes when compared to liberal thresholds (transfusing when the hemoglobin level is 9-10 g/dL).
For RBC storage duration, there were 13 trials including 5515 subjects. The results suggested that transfusing fresher blood did not improve clinical outcomes.
Transfusion threshold
The guideline authors said it is good practice, when making transfusion decisions, to consider the patient’s hemoglobin level, the overall clinical context, patient preference, and alternative therapies.
However, in general, a hemoglobin level of 7 g/dL should serve as the threshold for transfusing adult patients who are hemodynamically stable, even if they are in critical care. This is a strong recommendation based on moderate-quality evidence.
“While the recommended threshold of 7 g/dL is consistent with previous AABB guidelines, the strength of the new recommendation reflects the quality and quantity of the new data, much of which was generated since 2012,” said guideline author Jeffrey Carson, MD, of Robert Wood Johnson University Hospital in New Brunswick, New Jersey.
“Clinically, these results show that no harm will come from waiting to transfuse a patient until the hemoglobin level reaches a lower point. The restrictive approach is associated with reductions in blood use, blood conservation, and lower expenses.”
The guidelines also state that, for patients with pre-existing cardiovascular disease and those undergoing cardiac or orthopedic surgery, the threshold should be 8 g/dL. This is a strong recommendation based on moderate-quality evidence.
Neither of the aforementioned recommendations apply to patients with acute coronary syndrome, severe thrombocytopenia, or chronic transfusion-dependent anemia.
Dr Carson said additional trials are needed to determine whether these patients benefit from transfusion at higher hemoglobin levels.
“We are about to embark on a large, international clinical trial supported by the NIH [National Institutes of Health] that will provide the evidence needed to determine the best course of action for patients who have had a heart attack,” he said.
Dr Carson and his colleagues also noted that, although the recommendations are based on the available evidence, the hemoglobin transfusion thresholds assessed may not be optimal. And the use of hemoglobin transfusion thresholds may be an imperfect surrogate for oxygen delivery.
Storage duration
The guidelines state that most patients, including neonates, should receive standard-issue RBCs (stored for 42 days or less) rather than limiting patients to only fresh RBCs (stored for less than 10 days). This is a strong recommendation based on moderate-quality evidence.
The trials analyzed showed that patients who received standard-issue RBCs faced no higher risk of complications—including 30-day mortality, myocardial infarction, cerebrovascular accident, rebleeding, pneumonia, or thromboembolism—than those who received fresh RBCs.
However, the guideline authors said the trial results may not apply to RBCs nearing their expiration date (stored for 35 to 42 days), as only a small proportion of patients in these trials were exposed to such RBCs.
Furthermore, the trials did not include patients undergoing a massive or exchange transfusion, neonates and children with underlying renal disease at higher risk of hyperkalemia, patients undergoing intrauterine transfusions, or patients with hemoglobinopathies requiring chronic transfusion support.
So the optimal RBC storage duration for these patients is unknown.
Photo courtesy of UAB Hospital
AABB has released new guidelines on when to perform red blood cell (RBC) transfusions and the optimal duration of RBC storage.
The guidelines state that a restrictive transfusion threshold—waiting to transfuse until a patient’s hemoglobin level is 7-8 g/dL—is safe in most clinical settings.
And, for most patients, “fresh” RBCs—stored for less than 10 days—are no safer than standard-issue RBCs—stored for up to 42 days.
“One of the biggest controversies concerning transfusion therapy is whether older blood is harmful compared to fresher blood,” said guideline author Aaron Tobian, MD, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.
“Now, we have information that can accurately inform guidelines about red blood cell storage duration. If data suggest no harm from the use of standard-issue blood and fresher blood would only constrain the use of a limited resource, continuing with standard practice of using older blood is appropriate. The newly released guidelines now clearly inform the community.”
The guidelines were published in JAMA alongside a related editorial.
The recommendations in the guidelines are based on an analysis of randomized clinical trials in which researchers evaluated hemoglobin thresholds for RBC transfusion (trials conducted from 1950 through May 2016) and RBC storage duration (trials conducted from 1948 through May 2016).
For transfusion thresholds, there were 31 trials including 12,587 subjects. The results of these trials suggested that restrictive transfusion thresholds (transfusing when the hemoglobin level is 7-8 g/dL) were not associated with higher rates of adverse clinical outcomes when compared to liberal thresholds (transfusing when the hemoglobin level is 9-10 g/dL).
For RBC storage duration, there were 13 trials including 5515 subjects. The results suggested that transfusing fresher blood did not improve clinical outcomes.
Transfusion threshold
The guideline authors said it is good practice, when making transfusion decisions, to consider the patient’s hemoglobin level, the overall clinical context, patient preference, and alternative therapies.
However, in general, a hemoglobin level of 7 g/dL should serve as the threshold for transfusing adult patients who are hemodynamically stable, even if they are in critical care. This is a strong recommendation based on moderate-quality evidence.
“While the recommended threshold of 7 g/dL is consistent with previous AABB guidelines, the strength of the new recommendation reflects the quality and quantity of the new data, much of which was generated since 2012,” said guideline author Jeffrey Carson, MD, of Robert Wood Johnson University Hospital in New Brunswick, New Jersey.
“Clinically, these results show that no harm will come from waiting to transfuse a patient until the hemoglobin level reaches a lower point. The restrictive approach is associated with reductions in blood use, blood conservation, and lower expenses.”
The guidelines also state that, for patients with pre-existing cardiovascular disease and those undergoing cardiac or orthopedic surgery, the threshold should be 8 g/dL. This is a strong recommendation based on moderate-quality evidence.
Neither of the aforementioned recommendations apply to patients with acute coronary syndrome, severe thrombocytopenia, or chronic transfusion-dependent anemia.
Dr Carson said additional trials are needed to determine whether these patients benefit from transfusion at higher hemoglobin levels.
“We are about to embark on a large, international clinical trial supported by the NIH [National Institutes of Health] that will provide the evidence needed to determine the best course of action for patients who have had a heart attack,” he said.
Dr Carson and his colleagues also noted that, although the recommendations are based on the available evidence, the hemoglobin transfusion thresholds assessed may not be optimal. And the use of hemoglobin transfusion thresholds may be an imperfect surrogate for oxygen delivery.
Storage duration
The guidelines state that most patients, including neonates, should receive standard-issue RBCs (stored for 42 days or less) rather than limiting patients to only fresh RBCs (stored for less than 10 days). This is a strong recommendation based on moderate-quality evidence.
The trials analyzed showed that patients who received standard-issue RBCs faced no higher risk of complications—including 30-day mortality, myocardial infarction, cerebrovascular accident, rebleeding, pneumonia, or thromboembolism—than those who received fresh RBCs.
However, the guideline authors said the trial results may not apply to RBCs nearing their expiration date (stored for 35 to 42 days), as only a small proportion of patients in these trials were exposed to such RBCs.
Furthermore, the trials did not include patients undergoing a massive or exchange transfusion, neonates and children with underlying renal disease at higher risk of hyperkalemia, patients undergoing intrauterine transfusions, or patients with hemoglobinopathies requiring chronic transfusion support.
So the optimal RBC storage duration for these patients is unknown.
Plasmapheresis system cleared by FDA
Photo from Business Wire
The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Aurora™ Xi Plasmapheresis System.
The system collects plasma from donated blood and returns the remaining blood components to the donor.
The Aurora Xi Plasmapheresis System features a proprietary filtration-separation method that enables faster collection of source plasma, according to Fresenius Kabi, the company marketing the system.
“The system helps to improve plasma center efficiency and the overall experience for operators and donors,” said Dean Gregory, president, medical devices, Fresenius Kabi USA.
“Faster collection times mean more throughput for our customers, helping maximize the volumes of plasma they collect while assuring a good experience for plasma donors.”
Plasma collected via the Aurora Xi Plasmapheresis System can be used to treat bleeding disorders, burn victims, human immune deficiencies, and other chronic or genetic disorders.
The plasma can also be used to manufacture therapies such as albumin and intravenous immunoglobulin.
Photo from Business Wire
The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Aurora™ Xi Plasmapheresis System.
The system collects plasma from donated blood and returns the remaining blood components to the donor.
The Aurora Xi Plasmapheresis System features a proprietary filtration-separation method that enables faster collection of source plasma, according to Fresenius Kabi, the company marketing the system.
“The system helps to improve plasma center efficiency and the overall experience for operators and donors,” said Dean Gregory, president, medical devices, Fresenius Kabi USA.
“Faster collection times mean more throughput for our customers, helping maximize the volumes of plasma they collect while assuring a good experience for plasma donors.”
Plasma collected via the Aurora Xi Plasmapheresis System can be used to treat bleeding disorders, burn victims, human immune deficiencies, and other chronic or genetic disorders.
The plasma can also be used to manufacture therapies such as albumin and intravenous immunoglobulin.
Photo from Business Wire
The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Aurora™ Xi Plasmapheresis System.
The system collects plasma from donated blood and returns the remaining blood components to the donor.
The Aurora Xi Plasmapheresis System features a proprietary filtration-separation method that enables faster collection of source plasma, according to Fresenius Kabi, the company marketing the system.
“The system helps to improve plasma center efficiency and the overall experience for operators and donors,” said Dean Gregory, president, medical devices, Fresenius Kabi USA.
“Faster collection times mean more throughput for our customers, helping maximize the volumes of plasma they collect while assuring a good experience for plasma donors.”
Plasma collected via the Aurora Xi Plasmapheresis System can be used to treat bleeding disorders, burn victims, human immune deficiencies, and other chronic or genetic disorders.
The plasma can also be used to manufacture therapies such as albumin and intravenous immunoglobulin.
EMA says plasma/urine-derived meds are safe from Zika
Photo by Cristina Granados
Patients who take plasma-derived or urine-derived medicines do not have to worry about these products being contaminated with Zika virus, according to the European Medicines Agency (EMA).
The agency said assessments have confirmed that manufacturing processes for these medicines—which include coagulation factors, immunoglobulins, and urokinase products—successfully inactivate or remove the Zika virus.
These medicines are produced from body fluids that might be sourced in parts of the world where the Zika virus is prevalent. So regulators in the European Union (EU) sought reassurance that there is no risk of the virus contaminating the final product and thus affecting the patients taking these medicines.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) investigated the potential risk with plasma-derived medicinal products.
And the Co-ordination Group for Mutual Recognition and Decentralised Procedures—Human (CMDh) has coordinated the assessment by EU member states on the potential risk with urine-derived medicinal products.
The CHMP concluded at its meeting last week that the manufacturing processes used for plasma-derived products—including, for example, the solvent/detergent method to inactivate viruses, pasteurization, and virus filtration—inactivate or remove the Zika virus from the finished product.
The CHMP therefore concluded that no additional safety measures, such as the testing or exclusion of certain plasma donors, were necessary.
The CMDh, following an assessment of data, concluded that the manufacturing processes for urine-derived products contain complementary steps with inactivation/removal capacity for enveloped viruses, which are considered sufficient for eliminating Zika virus.
Additional safety measures, such as screening urine donors/donations or deferring donors returning from Zika-affected areas, are not considered necessary.
The findings from these assessments are available in a report from the CHMP’s Biologics Working Party.
The Biologics Working Party recommendation on plasma-derived products is in line with the guidance published in July 2016 by the European Centre for Disease Prevention and Control.
Photo by Cristina Granados
Patients who take plasma-derived or urine-derived medicines do not have to worry about these products being contaminated with Zika virus, according to the European Medicines Agency (EMA).
The agency said assessments have confirmed that manufacturing processes for these medicines—which include coagulation factors, immunoglobulins, and urokinase products—successfully inactivate or remove the Zika virus.
These medicines are produced from body fluids that might be sourced in parts of the world where the Zika virus is prevalent. So regulators in the European Union (EU) sought reassurance that there is no risk of the virus contaminating the final product and thus affecting the patients taking these medicines.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) investigated the potential risk with plasma-derived medicinal products.
And the Co-ordination Group for Mutual Recognition and Decentralised Procedures—Human (CMDh) has coordinated the assessment by EU member states on the potential risk with urine-derived medicinal products.
The CHMP concluded at its meeting last week that the manufacturing processes used for plasma-derived products—including, for example, the solvent/detergent method to inactivate viruses, pasteurization, and virus filtration—inactivate or remove the Zika virus from the finished product.
The CHMP therefore concluded that no additional safety measures, such as the testing or exclusion of certain plasma donors, were necessary.
The CMDh, following an assessment of data, concluded that the manufacturing processes for urine-derived products contain complementary steps with inactivation/removal capacity for enveloped viruses, which are considered sufficient for eliminating Zika virus.
Additional safety measures, such as screening urine donors/donations or deferring donors returning from Zika-affected areas, are not considered necessary.
The findings from these assessments are available in a report from the CHMP’s Biologics Working Party.
The Biologics Working Party recommendation on plasma-derived products is in line with the guidance published in July 2016 by the European Centre for Disease Prevention and Control.
Photo by Cristina Granados
Patients who take plasma-derived or urine-derived medicines do not have to worry about these products being contaminated with Zika virus, according to the European Medicines Agency (EMA).
The agency said assessments have confirmed that manufacturing processes for these medicines—which include coagulation factors, immunoglobulins, and urokinase products—successfully inactivate or remove the Zika virus.
These medicines are produced from body fluids that might be sourced in parts of the world where the Zika virus is prevalent. So regulators in the European Union (EU) sought reassurance that there is no risk of the virus contaminating the final product and thus affecting the patients taking these medicines.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) investigated the potential risk with plasma-derived medicinal products.
And the Co-ordination Group for Mutual Recognition and Decentralised Procedures—Human (CMDh) has coordinated the assessment by EU member states on the potential risk with urine-derived medicinal products.
The CHMP concluded at its meeting last week that the manufacturing processes used for plasma-derived products—including, for example, the solvent/detergent method to inactivate viruses, pasteurization, and virus filtration—inactivate or remove the Zika virus from the finished product.
The CHMP therefore concluded that no additional safety measures, such as the testing or exclusion of certain plasma donors, were necessary.
The CMDh, following an assessment of data, concluded that the manufacturing processes for urine-derived products contain complementary steps with inactivation/removal capacity for enveloped viruses, which are considered sufficient for eliminating Zika virus.
Additional safety measures, such as screening urine donors/donations or deferring donors returning from Zika-affected areas, are not considered necessary.
The findings from these assessments are available in a report from the CHMP’s Biologics Working Party.
The Biologics Working Party recommendation on plasma-derived products is in line with the guidance published in July 2016 by the European Centre for Disease Prevention and Control.