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FDA approves first supplemental test for HTLV-I/II

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Fri, 12/12/2014 - 06:00
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FDA approves first supplemental test for HTLV-I/II

Blood in bags and vials

Credit: Daniel Gay

The US Food and Drug Administration (FDA) has approved the first supplemental test for human T-cell lymphotropic virus-I/II (HTLV-I/II).

The test, MP Diagnostics HTLV Blot 2.4, is a qualitative enzyme immunoassay intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive for HTLV-I/II.

MP Diagnostics HTLV Blot 2.4 can confirm infection with HTLV and differentiate between HTLV-I and HTLV-II.

The HTLVs are a group of human retroviruses known to cause diseases such as adult T-cell leukemia/lymphoma and myelopathy. HTLV can be transmitted from person to person through breastfeeding, unprotected sexual contact, or transfusion of blood from an infected donor.

Therefore, the FDA requires that donated blood be tested for HTLV-I/II antibodies. Currently, there are 2 FDA-licensed screening tests for HTLV-I/II. If a test is positive, the donation is discarded, and the donor is notified of his or her deferral.

The MP Diagnostics HTLV Blot 2.4 can provide blood establishments with additional information to convey to the donor. Specifically, the test can confirm HTLV infection and determine which virus type is causing the infection, HTLV-I or HTLV-II.

“The approval of MP Diagnostics HTLV Blot 2.4 will help blood establishments better counsel donors who have had positive results on an FDA-licensed HTLV-I/II screening test,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research.

MP Diagnostics HTLV Blot 2.4 is manufactured by MP Biomedicals Asia Pacific Pte. Ltd. in Singapore, a company of MP Biomedicals LLC in Santa Ana, California. For more information on the test, visit the MP Biomedicals website.

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Blood in bags and vials

Credit: Daniel Gay

The US Food and Drug Administration (FDA) has approved the first supplemental test for human T-cell lymphotropic virus-I/II (HTLV-I/II).

The test, MP Diagnostics HTLV Blot 2.4, is a qualitative enzyme immunoassay intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive for HTLV-I/II.

MP Diagnostics HTLV Blot 2.4 can confirm infection with HTLV and differentiate between HTLV-I and HTLV-II.

The HTLVs are a group of human retroviruses known to cause diseases such as adult T-cell leukemia/lymphoma and myelopathy. HTLV can be transmitted from person to person through breastfeeding, unprotected sexual contact, or transfusion of blood from an infected donor.

Therefore, the FDA requires that donated blood be tested for HTLV-I/II antibodies. Currently, there are 2 FDA-licensed screening tests for HTLV-I/II. If a test is positive, the donation is discarded, and the donor is notified of his or her deferral.

The MP Diagnostics HTLV Blot 2.4 can provide blood establishments with additional information to convey to the donor. Specifically, the test can confirm HTLV infection and determine which virus type is causing the infection, HTLV-I or HTLV-II.

“The approval of MP Diagnostics HTLV Blot 2.4 will help blood establishments better counsel donors who have had positive results on an FDA-licensed HTLV-I/II screening test,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research.

MP Diagnostics HTLV Blot 2.4 is manufactured by MP Biomedicals Asia Pacific Pte. Ltd. in Singapore, a company of MP Biomedicals LLC in Santa Ana, California. For more information on the test, visit the MP Biomedicals website.

Blood in bags and vials

Credit: Daniel Gay

The US Food and Drug Administration (FDA) has approved the first supplemental test for human T-cell lymphotropic virus-I/II (HTLV-I/II).

The test, MP Diagnostics HTLV Blot 2.4, is a qualitative enzyme immunoassay intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive for HTLV-I/II.

MP Diagnostics HTLV Blot 2.4 can confirm infection with HTLV and differentiate between HTLV-I and HTLV-II.

The HTLVs are a group of human retroviruses known to cause diseases such as adult T-cell leukemia/lymphoma and myelopathy. HTLV can be transmitted from person to person through breastfeeding, unprotected sexual contact, or transfusion of blood from an infected donor.

Therefore, the FDA requires that donated blood be tested for HTLV-I/II antibodies. Currently, there are 2 FDA-licensed screening tests for HTLV-I/II. If a test is positive, the donation is discarded, and the donor is notified of his or her deferral.

The MP Diagnostics HTLV Blot 2.4 can provide blood establishments with additional information to convey to the donor. Specifically, the test can confirm HTLV infection and determine which virus type is causing the infection, HTLV-I or HTLV-II.

“The approval of MP Diagnostics HTLV Blot 2.4 will help blood establishments better counsel donors who have had positive results on an FDA-licensed HTLV-I/II screening test,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research.

MP Diagnostics HTLV Blot 2.4 is manufactured by MP Biomedicals Asia Pacific Pte. Ltd. in Singapore, a company of MP Biomedicals LLC in Santa Ana, California. For more information on the test, visit the MP Biomedicals website.

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ASH adds practices to Choosing Wisely list

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Thu, 12/04/2014 - 06:00
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ASH adds practices to Choosing Wisely list

Doctor consults with a family

Credit: Rhoda Baer

The American Society of Hematology (ASH) has released a second list of 5 commonly used tests, treatments, and procedures that physicians and patients should question in certain circumstances.

The additional items join an initial list of practices released last year as part of the Choosing Wisely® campaign, an initiative of the ABIM Foundation that aims to prompt conversations between patients and physicians about the necessity and potential harm of certain procedures.

These new “practices to question” are also highlighted in a manuscript published in Blood, which further describes the methods for developing the list and the evidentiary basis of the recommendations.

The new recommendations include:

  1. Don’t treat with an anticoagulant for more than 3 months in a patient with a first venous thromboembolism occurring in the setting of a major transient risk factor.
  2. Don’t routinely transfuse patients with sickle cell disease for chronic anemia or uncomplicated pain crisis without an appropriate clinical indication.
  3. Don’t perform baseline or routine surveillance CT scans in patients with asymptomatic, early stage chronic lymphocytic leukemia.
  4. Don’t test or treat for suspected heparin-induced thrombocytopenia (HIT) in patients with a low pre-test probability of HIT.
  5. Don’t treat patients with immune thrombocytopenic purpura in the absence of bleeding or a very low platelet count.

The second Choosing Wisely list was developed using a rigorous evidence-based methodology that incorporated suggestions from ASH members and prioritized avoiding harm to patients above all other considerations.

“Unnecessary treatments or tests not only add waste to the healthcare system, but, in some cases, they also expose our patients to a risk of harm,” said Lisa Hicks, MD, of St Michael’s Hospital and the University of Toronto and chair of the ASH Choosing Wisely Task Force.

“ASH developed its second Choosing Wisely list to help hematologists manage the utilization and delivery of patient-care resources, and the society encourages hematologists to consider these recommendations in all facets of their work, including patient care, teaching, innovation, and research.”

The dominant guiding principle for ASH’s list is the concept of avoiding harm. The four other established guiding principles of ASH’s involvement in the Choosing Wisely campaign are strength of evidence, aggregate cost, frequency, and making recommendations within the purview of hematology. This year, the task force added a sixth overarching principle of potential impact in the field.

“Choosing Wisely set out to stimulate conversations about waste and overuse in our healthcare system,” said Richard J. Baron, MD, President and CEO of the ABIM Foundation.

“We’ve been fortunate to be joined in this effort by many dedicated partners—including ASH—who have committed to addressing unnecessary care in their specialty. ASH’s second Choosing Wisely list gives clinicians and patients a new and important tool to help inform their conversations about what care is best for the patient.”

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Doctor consults with a family

Credit: Rhoda Baer

The American Society of Hematology (ASH) has released a second list of 5 commonly used tests, treatments, and procedures that physicians and patients should question in certain circumstances.

The additional items join an initial list of practices released last year as part of the Choosing Wisely® campaign, an initiative of the ABIM Foundation that aims to prompt conversations between patients and physicians about the necessity and potential harm of certain procedures.

These new “practices to question” are also highlighted in a manuscript published in Blood, which further describes the methods for developing the list and the evidentiary basis of the recommendations.

The new recommendations include:

  1. Don’t treat with an anticoagulant for more than 3 months in a patient with a first venous thromboembolism occurring in the setting of a major transient risk factor.
  2. Don’t routinely transfuse patients with sickle cell disease for chronic anemia or uncomplicated pain crisis without an appropriate clinical indication.
  3. Don’t perform baseline or routine surveillance CT scans in patients with asymptomatic, early stage chronic lymphocytic leukemia.
  4. Don’t test or treat for suspected heparin-induced thrombocytopenia (HIT) in patients with a low pre-test probability of HIT.
  5. Don’t treat patients with immune thrombocytopenic purpura in the absence of bleeding or a very low platelet count.

The second Choosing Wisely list was developed using a rigorous evidence-based methodology that incorporated suggestions from ASH members and prioritized avoiding harm to patients above all other considerations.

“Unnecessary treatments or tests not only add waste to the healthcare system, but, in some cases, they also expose our patients to a risk of harm,” said Lisa Hicks, MD, of St Michael’s Hospital and the University of Toronto and chair of the ASH Choosing Wisely Task Force.

“ASH developed its second Choosing Wisely list to help hematologists manage the utilization and delivery of patient-care resources, and the society encourages hematologists to consider these recommendations in all facets of their work, including patient care, teaching, innovation, and research.”

The dominant guiding principle for ASH’s list is the concept of avoiding harm. The four other established guiding principles of ASH’s involvement in the Choosing Wisely campaign are strength of evidence, aggregate cost, frequency, and making recommendations within the purview of hematology. This year, the task force added a sixth overarching principle of potential impact in the field.

“Choosing Wisely set out to stimulate conversations about waste and overuse in our healthcare system,” said Richard J. Baron, MD, President and CEO of the ABIM Foundation.

“We’ve been fortunate to be joined in this effort by many dedicated partners—including ASH—who have committed to addressing unnecessary care in their specialty. ASH’s second Choosing Wisely list gives clinicians and patients a new and important tool to help inform their conversations about what care is best for the patient.”

Doctor consults with a family

Credit: Rhoda Baer

The American Society of Hematology (ASH) has released a second list of 5 commonly used tests, treatments, and procedures that physicians and patients should question in certain circumstances.

The additional items join an initial list of practices released last year as part of the Choosing Wisely® campaign, an initiative of the ABIM Foundation that aims to prompt conversations between patients and physicians about the necessity and potential harm of certain procedures.

These new “practices to question” are also highlighted in a manuscript published in Blood, which further describes the methods for developing the list and the evidentiary basis of the recommendations.

The new recommendations include:

  1. Don’t treat with an anticoagulant for more than 3 months in a patient with a first venous thromboembolism occurring in the setting of a major transient risk factor.
  2. Don’t routinely transfuse patients with sickle cell disease for chronic anemia or uncomplicated pain crisis without an appropriate clinical indication.
  3. Don’t perform baseline or routine surveillance CT scans in patients with asymptomatic, early stage chronic lymphocytic leukemia.
  4. Don’t test or treat for suspected heparin-induced thrombocytopenia (HIT) in patients with a low pre-test probability of HIT.
  5. Don’t treat patients with immune thrombocytopenic purpura in the absence of bleeding or a very low platelet count.

The second Choosing Wisely list was developed using a rigorous evidence-based methodology that incorporated suggestions from ASH members and prioritized avoiding harm to patients above all other considerations.

“Unnecessary treatments or tests not only add waste to the healthcare system, but, in some cases, they also expose our patients to a risk of harm,” said Lisa Hicks, MD, of St Michael’s Hospital and the University of Toronto and chair of the ASH Choosing Wisely Task Force.

“ASH developed its second Choosing Wisely list to help hematologists manage the utilization and delivery of patient-care resources, and the society encourages hematologists to consider these recommendations in all facets of their work, including patient care, teaching, innovation, and research.”

The dominant guiding principle for ASH’s list is the concept of avoiding harm. The four other established guiding principles of ASH’s involvement in the Choosing Wisely campaign are strength of evidence, aggregate cost, frequency, and making recommendations within the purview of hematology. This year, the task force added a sixth overarching principle of potential impact in the field.

“Choosing Wisely set out to stimulate conversations about waste and overuse in our healthcare system,” said Richard J. Baron, MD, President and CEO of the ABIM Foundation.

“We’ve been fortunate to be joined in this effort by many dedicated partners—including ASH—who have committed to addressing unnecessary care in their specialty. ASH’s second Choosing Wisely list gives clinicians and patients a new and important tool to help inform their conversations about what care is best for the patient.”

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FDA OKs use of system to treat Ebola convalescent plasma

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Sun, 11/23/2014 - 06:00
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FDA OKs use of system to treat Ebola convalescent plasma

Plasma for transfusion

Credit: Cristina Granados

The US Food and Drug Administration (FDA) has accepted a clinical protocol to make the INTERCEPT Blood System available to treat plasma collected from Ebola survivors.

Transfusion of blood or plasma from recovered Ebola patients can be of benefit in patients with acute Ebola infections, but recovered patients may carry undetected pathogens such as malaria, which is where the INTERCEPT Blood System for plasma comes in.

The system is used for the preparation and storage of whole blood-derived and apheresis plasma (fresh or recently thawed). It can inactivate a range of viruses, bacteria, and parasites to reduce the risk of transmission via transfusion.

“The INTERCEPT pathogen inactivation process can diminish the risk of other pathogens that may contaminate the plasma of valuable Ebola convalescent donors and will provide a new therapeutic resource for patients with Ebola,” said Laurence Corash, MD, senior vice president and chief medical officer of Cerus Corporation, the company developing the INTERCEPT system.

The INTERCEPT Blood System for plasma does not have FDA approval. The agency has approved use of the system via an investigational device exemption (IDE). This allows for early access to a device not yet approved in the US when no satisfactory alternative is available to treat patients with serious or life-threatening conditions.

Under this IDE, investigators at Emory University will collect Ebola convalescent plasma from recovered patients and use the INTERCEPT system for onsite pathogen inactivation.

Following testing for Ebola antibodies at the Centers for Disease Control and Prevention, the treated plasma will be stored at Emory for use with future patients. If needed, Emory will also supply the treated plasma for use at other Ebola treatment centers, such as the University of Nebraska Medical Center.

To further increase the availability of convalescent plasma, Cerus and the trial investigators are collaborating with the American Red Cross and America’s Blood Centers to create a national network of plasma collection sites to access recovered Ebola patients.

“Having a supply of convalescent plasma that has been through pathogen inactivation is critical to making this therapy readily available as new Ebola patients are diagnosed and urgently require treatment,” said Anne Winkler, MD, principal investigator for the study and an assistant professor at the Emory University School of Medicine in Atlanta, Georgia.

The World Health Organization recently identified convalescent plasma as a potentially promising experimental approach to treat Ebola, issuing interim guidance suggesting how the plasma should be sourced and supplied.

The Bill & Melinda Gates Foundation recently announced a $5.7 million commitment to support efforts in Guinea and other Ebola-affected countries to scale up the production and evaluation of potential therapies for people infected with the Ebola virus, including convalescent plasma treated with pathogen inactivation.

Funding is being provided to Clinical Research Management, Inc., and an array of private sector partners to study Ebola convalescent plasma that will be collected through mobile donation units fully equipped with apheresis plasma collection systems and the INTERCEPT Blood System for plasma.

The INTERCEPT platelet and plasma systems have been approved for use in Europe for 8 years and are used in 20 countries. License applications for the systems are under FDA review, with an approval decision expected in 2015.

The FDA recently accepted Cerus’s clinical protocol to make the INTERCEPT Blood System for platelets available under an IDE to regions in the US and its territories with outbreaks of Chikungunya and dengue virus.

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Plasma for transfusion

Credit: Cristina Granados

The US Food and Drug Administration (FDA) has accepted a clinical protocol to make the INTERCEPT Blood System available to treat plasma collected from Ebola survivors.

Transfusion of blood or plasma from recovered Ebola patients can be of benefit in patients with acute Ebola infections, but recovered patients may carry undetected pathogens such as malaria, which is where the INTERCEPT Blood System for plasma comes in.

The system is used for the preparation and storage of whole blood-derived and apheresis plasma (fresh or recently thawed). It can inactivate a range of viruses, bacteria, and parasites to reduce the risk of transmission via transfusion.

“The INTERCEPT pathogen inactivation process can diminish the risk of other pathogens that may contaminate the plasma of valuable Ebola convalescent donors and will provide a new therapeutic resource for patients with Ebola,” said Laurence Corash, MD, senior vice president and chief medical officer of Cerus Corporation, the company developing the INTERCEPT system.

The INTERCEPT Blood System for plasma does not have FDA approval. The agency has approved use of the system via an investigational device exemption (IDE). This allows for early access to a device not yet approved in the US when no satisfactory alternative is available to treat patients with serious or life-threatening conditions.

Under this IDE, investigators at Emory University will collect Ebola convalescent plasma from recovered patients and use the INTERCEPT system for onsite pathogen inactivation.

Following testing for Ebola antibodies at the Centers for Disease Control and Prevention, the treated plasma will be stored at Emory for use with future patients. If needed, Emory will also supply the treated plasma for use at other Ebola treatment centers, such as the University of Nebraska Medical Center.

To further increase the availability of convalescent plasma, Cerus and the trial investigators are collaborating with the American Red Cross and America’s Blood Centers to create a national network of plasma collection sites to access recovered Ebola patients.

“Having a supply of convalescent plasma that has been through pathogen inactivation is critical to making this therapy readily available as new Ebola patients are diagnosed and urgently require treatment,” said Anne Winkler, MD, principal investigator for the study and an assistant professor at the Emory University School of Medicine in Atlanta, Georgia.

The World Health Organization recently identified convalescent plasma as a potentially promising experimental approach to treat Ebola, issuing interim guidance suggesting how the plasma should be sourced and supplied.

The Bill & Melinda Gates Foundation recently announced a $5.7 million commitment to support efforts in Guinea and other Ebola-affected countries to scale up the production and evaluation of potential therapies for people infected with the Ebola virus, including convalescent plasma treated with pathogen inactivation.

Funding is being provided to Clinical Research Management, Inc., and an array of private sector partners to study Ebola convalescent plasma that will be collected through mobile donation units fully equipped with apheresis plasma collection systems and the INTERCEPT Blood System for plasma.

The INTERCEPT platelet and plasma systems have been approved for use in Europe for 8 years and are used in 20 countries. License applications for the systems are under FDA review, with an approval decision expected in 2015.

The FDA recently accepted Cerus’s clinical protocol to make the INTERCEPT Blood System for platelets available under an IDE to regions in the US and its territories with outbreaks of Chikungunya and dengue virus.

Plasma for transfusion

Credit: Cristina Granados

The US Food and Drug Administration (FDA) has accepted a clinical protocol to make the INTERCEPT Blood System available to treat plasma collected from Ebola survivors.

Transfusion of blood or plasma from recovered Ebola patients can be of benefit in patients with acute Ebola infections, but recovered patients may carry undetected pathogens such as malaria, which is where the INTERCEPT Blood System for plasma comes in.

The system is used for the preparation and storage of whole blood-derived and apheresis plasma (fresh or recently thawed). It can inactivate a range of viruses, bacteria, and parasites to reduce the risk of transmission via transfusion.

“The INTERCEPT pathogen inactivation process can diminish the risk of other pathogens that may contaminate the plasma of valuable Ebola convalescent donors and will provide a new therapeutic resource for patients with Ebola,” said Laurence Corash, MD, senior vice president and chief medical officer of Cerus Corporation, the company developing the INTERCEPT system.

The INTERCEPT Blood System for plasma does not have FDA approval. The agency has approved use of the system via an investigational device exemption (IDE). This allows for early access to a device not yet approved in the US when no satisfactory alternative is available to treat patients with serious or life-threatening conditions.

Under this IDE, investigators at Emory University will collect Ebola convalescent plasma from recovered patients and use the INTERCEPT system for onsite pathogen inactivation.

Following testing for Ebola antibodies at the Centers for Disease Control and Prevention, the treated plasma will be stored at Emory for use with future patients. If needed, Emory will also supply the treated plasma for use at other Ebola treatment centers, such as the University of Nebraska Medical Center.

To further increase the availability of convalescent plasma, Cerus and the trial investigators are collaborating with the American Red Cross and America’s Blood Centers to create a national network of plasma collection sites to access recovered Ebola patients.

“Having a supply of convalescent plasma that has been through pathogen inactivation is critical to making this therapy readily available as new Ebola patients are diagnosed and urgently require treatment,” said Anne Winkler, MD, principal investigator for the study and an assistant professor at the Emory University School of Medicine in Atlanta, Georgia.

The World Health Organization recently identified convalescent plasma as a potentially promising experimental approach to treat Ebola, issuing interim guidance suggesting how the plasma should be sourced and supplied.

The Bill & Melinda Gates Foundation recently announced a $5.7 million commitment to support efforts in Guinea and other Ebola-affected countries to scale up the production and evaluation of potential therapies for people infected with the Ebola virus, including convalescent plasma treated with pathogen inactivation.

Funding is being provided to Clinical Research Management, Inc., and an array of private sector partners to study Ebola convalescent plasma that will be collected through mobile donation units fully equipped with apheresis plasma collection systems and the INTERCEPT Blood System for plasma.

The INTERCEPT platelet and plasma systems have been approved for use in Europe for 8 years and are used in 20 countries. License applications for the systems are under FDA review, with an approval decision expected in 2015.

The FDA recently accepted Cerus’s clinical protocol to make the INTERCEPT Blood System for platelets available under an IDE to regions in the US and its territories with outbreaks of Chikungunya and dengue virus.

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Device could streamline preparation of frozen RBCs

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Tue, 11/18/2014 - 06:00
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Device could streamline preparation of frozen RBCs

Blood for transfusion

Engineers have devised a method that could allow for faster preparation of frozen red blood cells (RBCs), according to research published in Biomicrofluidics.

It’s already possible to cryopreserve RBCs in the presence of 40% glycerol, but the post-thaw washing process can take an hour or more.

Initial experiments and computer modeling suggest this process can be streamlined to take as little as 3 minutes, using a membrane-based microfluidic device.

This could make it more feasible to use frozen blood in emergency or time-constrained medical situations.

“Only a small fraction of our blood supply is now frozen because it’s often impractical to wait so long when a transfusion is needed immediately,” said study author Adam Higgins, PhD, of Oregon State University in Corvallis.

“Because of that, our entire system depends on constantly balancing the use and supply of blood products that can only last 6 weeks or less with refrigeration. This is difficult and can lead to loss of outdated blood, periodic shortages, and other inefficiencies that could be solved with the use of frozen blood.”

With this in mind, the researchers explored the potential for rapid glycerol extraction using a membrane-based microfluidic device.

They theorized that extremely tiny microchannel plates and membranes could be used to precisely control the removal of glycerol at a time scale of seconds, without causing excessive osmotic damage.

The team developed a mass transfer model that allowed them to predict glycerol removal, as well as the resulting cell volume changes.

Results of the researchers’ experiments were in line with the predictions and suggest it is possible to reduce the glycerol concentration by more than 50% without excessive hemolysis.

Now, the team hopes to create working prototypes of the needed technology for further development and testing of this concept. They believe an optimized process may be even faster than the 3 minutes now being predicted.

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Blood for transfusion

Engineers have devised a method that could allow for faster preparation of frozen red blood cells (RBCs), according to research published in Biomicrofluidics.

It’s already possible to cryopreserve RBCs in the presence of 40% glycerol, but the post-thaw washing process can take an hour or more.

Initial experiments and computer modeling suggest this process can be streamlined to take as little as 3 minutes, using a membrane-based microfluidic device.

This could make it more feasible to use frozen blood in emergency or time-constrained medical situations.

“Only a small fraction of our blood supply is now frozen because it’s often impractical to wait so long when a transfusion is needed immediately,” said study author Adam Higgins, PhD, of Oregon State University in Corvallis.

“Because of that, our entire system depends on constantly balancing the use and supply of blood products that can only last 6 weeks or less with refrigeration. This is difficult and can lead to loss of outdated blood, periodic shortages, and other inefficiencies that could be solved with the use of frozen blood.”

With this in mind, the researchers explored the potential for rapid glycerol extraction using a membrane-based microfluidic device.

They theorized that extremely tiny microchannel plates and membranes could be used to precisely control the removal of glycerol at a time scale of seconds, without causing excessive osmotic damage.

The team developed a mass transfer model that allowed them to predict glycerol removal, as well as the resulting cell volume changes.

Results of the researchers’ experiments were in line with the predictions and suggest it is possible to reduce the glycerol concentration by more than 50% without excessive hemolysis.

Now, the team hopes to create working prototypes of the needed technology for further development and testing of this concept. They believe an optimized process may be even faster than the 3 minutes now being predicted.

Blood for transfusion

Engineers have devised a method that could allow for faster preparation of frozen red blood cells (RBCs), according to research published in Biomicrofluidics.

It’s already possible to cryopreserve RBCs in the presence of 40% glycerol, but the post-thaw washing process can take an hour or more.

Initial experiments and computer modeling suggest this process can be streamlined to take as little as 3 minutes, using a membrane-based microfluidic device.

This could make it more feasible to use frozen blood in emergency or time-constrained medical situations.

“Only a small fraction of our blood supply is now frozen because it’s often impractical to wait so long when a transfusion is needed immediately,” said study author Adam Higgins, PhD, of Oregon State University in Corvallis.

“Because of that, our entire system depends on constantly balancing the use and supply of blood products that can only last 6 weeks or less with refrigeration. This is difficult and can lead to loss of outdated blood, periodic shortages, and other inefficiencies that could be solved with the use of frozen blood.”

With this in mind, the researchers explored the potential for rapid glycerol extraction using a membrane-based microfluidic device.

They theorized that extremely tiny microchannel plates and membranes could be used to precisely control the removal of glycerol at a time scale of seconds, without causing excessive osmotic damage.

The team developed a mass transfer model that allowed them to predict glycerol removal, as well as the resulting cell volume changes.

Results of the researchers’ experiments were in line with the predictions and suggest it is possible to reduce the glycerol concentration by more than 50% without excessive hemolysis.

Now, the team hopes to create working prototypes of the needed technology for further development and testing of this concept. They believe an optimized process may be even faster than the 3 minutes now being predicted.

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Will US lift ban on MSM blood donation?

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Sat, 11/15/2014 - 06:00
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Will US lift ban on MSM blood donation?

Blood in bags and vials

Credit: Daniel Gay

A committee that advises the US Department of Health and Human Services (HHS) has recommended  changing the policy that prevents men who have sex with men (MSM) from donating blood.

The Advisory Committee on Blood and Tissue Safety and Availability decided MSM should be allowed to donate blood if they have abstained from sex for a year.

A group of advisers to the US Food and Drug Administration (FDA) will consider this recommendation in a meeting on December 2.

The HHS advisory committee plans to meet on December 5 to discuss establishing a donor transfusion-transmissible infection-monitoring system. The HHS has said such a system should be put in place before lifting the lifetime ban on MSM blood donation.

Should the FDA decide to change its policy, the US would follow other countries that have lifted the lifetime ban in recent years.

For instance, MSM in the UK and Australia are now allowed to donate blood if they have been celibate for a year, MSM in Canada must be celibate for 5 years, and MSM in South Africa can donate if they have been celibate or in a monogamous relationship for 6 months.

The safety of the blood supply

Lifting the lifetime ban on MSM blood donors may raise concerns about the safety of the blood supply, with transfusion recipients worrying they will have a greater risk of contracting HIV.

Although donated blood is tested for HIV, there is an 11-day window in which current tests cannot detect the virus in people who just contracted it. And MSM are more severely affected by HIV than any other group in the US, according to the Centers for Disease Control and Prevention.

Of course, deferring MSM donation for a year would allow enough time for HIV to be strong enough for tests to detect the virus. However, that assumes that donors are telling the truth about their sexual practices.

A study of more than 1000 MSM in Britain showed that 11% had donated blood after having penetrative sex with a man, and 3% had done so in the past 12 months, despite the lifetime ban on MSM blood donation. The study was conducted before the UK lifted the ban.

Still, study investigators said the results supported lifting the lifetime ban on MSM because men who did not comply with the ban generally said they would comply with a 1-year deferral period.

The AABB, America’s Blood Centers, and the American Red Cross have said they support a 1-year deferral period for MSM who want to donate blood in the US.

“This change in policy would align the donor deferral period for MSM with criteria for other activities that may pose a similar risk of transfusion-transmissible infections,” the groups said.

“We believe the current FDA indefinite blood donation deferral for a man who has sex with another man since 1977 is medically and scientifically unwarranted. The blood banking community strongly supports the use of rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar-risk activities.”

A report by the Williams Institute suggested that, if the FDA were to lift the ban on MSM completely, an additional 360,600 men could donate 615,300 additional pints of blood each year.

On the other hand, an HHS report suggested that the US supply of blood units is already surpassing demand. The report showed that 15.7 million units of whole blood and red blood cells were collected in 2011, and the total number of units transfused was 13.8 million.

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Blood in bags and vials

Credit: Daniel Gay

A committee that advises the US Department of Health and Human Services (HHS) has recommended  changing the policy that prevents men who have sex with men (MSM) from donating blood.

The Advisory Committee on Blood and Tissue Safety and Availability decided MSM should be allowed to donate blood if they have abstained from sex for a year.

A group of advisers to the US Food and Drug Administration (FDA) will consider this recommendation in a meeting on December 2.

The HHS advisory committee plans to meet on December 5 to discuss establishing a donor transfusion-transmissible infection-monitoring system. The HHS has said such a system should be put in place before lifting the lifetime ban on MSM blood donation.

Should the FDA decide to change its policy, the US would follow other countries that have lifted the lifetime ban in recent years.

For instance, MSM in the UK and Australia are now allowed to donate blood if they have been celibate for a year, MSM in Canada must be celibate for 5 years, and MSM in South Africa can donate if they have been celibate or in a monogamous relationship for 6 months.

The safety of the blood supply

Lifting the lifetime ban on MSM blood donors may raise concerns about the safety of the blood supply, with transfusion recipients worrying they will have a greater risk of contracting HIV.

Although donated blood is tested for HIV, there is an 11-day window in which current tests cannot detect the virus in people who just contracted it. And MSM are more severely affected by HIV than any other group in the US, according to the Centers for Disease Control and Prevention.

Of course, deferring MSM donation for a year would allow enough time for HIV to be strong enough for tests to detect the virus. However, that assumes that donors are telling the truth about their sexual practices.

A study of more than 1000 MSM in Britain showed that 11% had donated blood after having penetrative sex with a man, and 3% had done so in the past 12 months, despite the lifetime ban on MSM blood donation. The study was conducted before the UK lifted the ban.

Still, study investigators said the results supported lifting the lifetime ban on MSM because men who did not comply with the ban generally said they would comply with a 1-year deferral period.

The AABB, America’s Blood Centers, and the American Red Cross have said they support a 1-year deferral period for MSM who want to donate blood in the US.

“This change in policy would align the donor deferral period for MSM with criteria for other activities that may pose a similar risk of transfusion-transmissible infections,” the groups said.

“We believe the current FDA indefinite blood donation deferral for a man who has sex with another man since 1977 is medically and scientifically unwarranted. The blood banking community strongly supports the use of rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar-risk activities.”

A report by the Williams Institute suggested that, if the FDA were to lift the ban on MSM completely, an additional 360,600 men could donate 615,300 additional pints of blood each year.

On the other hand, an HHS report suggested that the US supply of blood units is already surpassing demand. The report showed that 15.7 million units of whole blood and red blood cells were collected in 2011, and the total number of units transfused was 13.8 million.

Blood in bags and vials

Credit: Daniel Gay

A committee that advises the US Department of Health and Human Services (HHS) has recommended  changing the policy that prevents men who have sex with men (MSM) from donating blood.

The Advisory Committee on Blood and Tissue Safety and Availability decided MSM should be allowed to donate blood if they have abstained from sex for a year.

A group of advisers to the US Food and Drug Administration (FDA) will consider this recommendation in a meeting on December 2.

The HHS advisory committee plans to meet on December 5 to discuss establishing a donor transfusion-transmissible infection-monitoring system. The HHS has said such a system should be put in place before lifting the lifetime ban on MSM blood donation.

Should the FDA decide to change its policy, the US would follow other countries that have lifted the lifetime ban in recent years.

For instance, MSM in the UK and Australia are now allowed to donate blood if they have been celibate for a year, MSM in Canada must be celibate for 5 years, and MSM in South Africa can donate if they have been celibate or in a monogamous relationship for 6 months.

The safety of the blood supply

Lifting the lifetime ban on MSM blood donors may raise concerns about the safety of the blood supply, with transfusion recipients worrying they will have a greater risk of contracting HIV.

Although donated blood is tested for HIV, there is an 11-day window in which current tests cannot detect the virus in people who just contracted it. And MSM are more severely affected by HIV than any other group in the US, according to the Centers for Disease Control and Prevention.

Of course, deferring MSM donation for a year would allow enough time for HIV to be strong enough for tests to detect the virus. However, that assumes that donors are telling the truth about their sexual practices.

A study of more than 1000 MSM in Britain showed that 11% had donated blood after having penetrative sex with a man, and 3% had done so in the past 12 months, despite the lifetime ban on MSM blood donation. The study was conducted before the UK lifted the ban.

Still, study investigators said the results supported lifting the lifetime ban on MSM because men who did not comply with the ban generally said they would comply with a 1-year deferral period.

The AABB, America’s Blood Centers, and the American Red Cross have said they support a 1-year deferral period for MSM who want to donate blood in the US.

“This change in policy would align the donor deferral period for MSM with criteria for other activities that may pose a similar risk of transfusion-transmissible infections,” the groups said.

“We believe the current FDA indefinite blood donation deferral for a man who has sex with another man since 1977 is medically and scientifically unwarranted. The blood banking community strongly supports the use of rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar-risk activities.”

A report by the Williams Institute suggested that, if the FDA were to lift the ban on MSM completely, an additional 360,600 men could donate 615,300 additional pints of blood each year.

On the other hand, an HHS report suggested that the US supply of blood units is already surpassing demand. The report showed that 15.7 million units of whole blood and red blood cells were collected in 2011, and the total number of units transfused was 13.8 million.

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Strategy could reduce TRALI after platelet transfusion

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Strategy could reduce TRALI after platelet transfusion

PHILADELPHIA—Researchers believe a simple screening strategy could reduce the risk of transfusion-related acute lung injury (TRALI) in patients receiving apheresis platelets (APs) by about 60%.

Studying TRALI cases reported to the American Red Cross, the investigators found evidence to support the idea that testing female AP donors who report prior pregnancy and deferring those with human leukocyte antigen (HLA) antibodies could greatly decrease the risk of TRALI.

Anne Eder, MD, of the American Red Cross in Rockville, Maryland, presented this research at the AABB Annual Meeting 2014 (abstract S82-040B).

Dr Eder and her colleagues assessed cases of TRALI and possible TRALI reported to the American Red Cross’s national hemovigilance program. The researchers compared the incidence of TRALI according to the type of blood component transfused as well as the sex of the donor.

TRALI cases due to APs and red blood cells (RBCs) from 2006 to 2013 and male-donor-predominant plasma from 2008 to 2013 were calculated as rates per 106 distributed units.

The blood center distributed 6.6 million AP units (>70% from male donors, excluding platelet additive solution), 9.6 million plasma units (>95% from male donors), and 48.6 million RBC units (54% from male donors).

In all, there were 224 cases of TRALI, 175 among patients who received a single type of blood component within 6 hours. There were 36 TRALI cases among plasma recipients, 92 among RBC recipients, and 41 among AP recipients.

The TRALI risk was about 3-fold greater for AP recipients than for RBC recipients or recipients of male-predominant plasma. The odds ratios (ORs) were 3.2, 1.0, and 0.8, respectively. The OR for all plasma recipients (including group AB female plasma) was 2.0.

The rate of fatalities was higher for AP recipients than RBC recipients, at 0.6 per 106 and 0.2 per 106, respectively (P=0.04).

When the researchers analyzed TRALI cases according to donor, they found a nearly 6-fold predilection for female donors among AP recipients (OR=5.6) and a nearly 5-fold predilection for female donors in RBC recipients (OR=4.5).

The investigators also considered the 41 AP TRALI cases individually to assess how effective a screening program might have been for reducing the risk of TRALI.

In 12 cases, patients had received AP from a male donor. Of the 29 female donors, 26 had reported a prior pregnancy, and 2 had test results suggesting a prior pregnancy.

Of those 28 donors, 3 were negative for HLA antibodies, leaving 25 cases, or 61%, positive for HLA antibodies.

Seventeen of the female donors had HLA class I and II antibodies, including 3 whose donation resulted in a fatality. One had HLA class I only, 2 had HLA class II only, 5 had HLA I or II and a specific human neutrophil antigen (HNA) antibody, and 1 had a specific HNA antibody only.

The researchers evaluated 7 cases in which donors had HLA class I or II antibodies. And they found that all 7 had signal-to-cutoff ratios much higher than any cutoff discussed for screening donors (greater than 100).

“So we predict that a strategy to test female apheresis donors who report prior pregnancy and to defer those with HLA antibodies may reduce the risk of TRALI by about 60% and prevent cases from human neutrophil antibodies as well,” Dr Eder concluded.

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PHILADELPHIA—Researchers believe a simple screening strategy could reduce the risk of transfusion-related acute lung injury (TRALI) in patients receiving apheresis platelets (APs) by about 60%.

Studying TRALI cases reported to the American Red Cross, the investigators found evidence to support the idea that testing female AP donors who report prior pregnancy and deferring those with human leukocyte antigen (HLA) antibodies could greatly decrease the risk of TRALI.

Anne Eder, MD, of the American Red Cross in Rockville, Maryland, presented this research at the AABB Annual Meeting 2014 (abstract S82-040B).

Dr Eder and her colleagues assessed cases of TRALI and possible TRALI reported to the American Red Cross’s national hemovigilance program. The researchers compared the incidence of TRALI according to the type of blood component transfused as well as the sex of the donor.

TRALI cases due to APs and red blood cells (RBCs) from 2006 to 2013 and male-donor-predominant plasma from 2008 to 2013 were calculated as rates per 106 distributed units.

The blood center distributed 6.6 million AP units (>70% from male donors, excluding platelet additive solution), 9.6 million plasma units (>95% from male donors), and 48.6 million RBC units (54% from male donors).

In all, there were 224 cases of TRALI, 175 among patients who received a single type of blood component within 6 hours. There were 36 TRALI cases among plasma recipients, 92 among RBC recipients, and 41 among AP recipients.

The TRALI risk was about 3-fold greater for AP recipients than for RBC recipients or recipients of male-predominant plasma. The odds ratios (ORs) were 3.2, 1.0, and 0.8, respectively. The OR for all plasma recipients (including group AB female plasma) was 2.0.

The rate of fatalities was higher for AP recipients than RBC recipients, at 0.6 per 106 and 0.2 per 106, respectively (P=0.04).

When the researchers analyzed TRALI cases according to donor, they found a nearly 6-fold predilection for female donors among AP recipients (OR=5.6) and a nearly 5-fold predilection for female donors in RBC recipients (OR=4.5).

The investigators also considered the 41 AP TRALI cases individually to assess how effective a screening program might have been for reducing the risk of TRALI.

In 12 cases, patients had received AP from a male donor. Of the 29 female donors, 26 had reported a prior pregnancy, and 2 had test results suggesting a prior pregnancy.

Of those 28 donors, 3 were negative for HLA antibodies, leaving 25 cases, or 61%, positive for HLA antibodies.

Seventeen of the female donors had HLA class I and II antibodies, including 3 whose donation resulted in a fatality. One had HLA class I only, 2 had HLA class II only, 5 had HLA I or II and a specific human neutrophil antigen (HNA) antibody, and 1 had a specific HNA antibody only.

The researchers evaluated 7 cases in which donors had HLA class I or II antibodies. And they found that all 7 had signal-to-cutoff ratios much higher than any cutoff discussed for screening donors (greater than 100).

“So we predict that a strategy to test female apheresis donors who report prior pregnancy and to defer those with HLA antibodies may reduce the risk of TRALI by about 60% and prevent cases from human neutrophil antibodies as well,” Dr Eder concluded.

PHILADELPHIA—Researchers believe a simple screening strategy could reduce the risk of transfusion-related acute lung injury (TRALI) in patients receiving apheresis platelets (APs) by about 60%.

Studying TRALI cases reported to the American Red Cross, the investigators found evidence to support the idea that testing female AP donors who report prior pregnancy and deferring those with human leukocyte antigen (HLA) antibodies could greatly decrease the risk of TRALI.

Anne Eder, MD, of the American Red Cross in Rockville, Maryland, presented this research at the AABB Annual Meeting 2014 (abstract S82-040B).

Dr Eder and her colleagues assessed cases of TRALI and possible TRALI reported to the American Red Cross’s national hemovigilance program. The researchers compared the incidence of TRALI according to the type of blood component transfused as well as the sex of the donor.

TRALI cases due to APs and red blood cells (RBCs) from 2006 to 2013 and male-donor-predominant plasma from 2008 to 2013 were calculated as rates per 106 distributed units.

The blood center distributed 6.6 million AP units (>70% from male donors, excluding platelet additive solution), 9.6 million plasma units (>95% from male donors), and 48.6 million RBC units (54% from male donors).

In all, there were 224 cases of TRALI, 175 among patients who received a single type of blood component within 6 hours. There were 36 TRALI cases among plasma recipients, 92 among RBC recipients, and 41 among AP recipients.

The TRALI risk was about 3-fold greater for AP recipients than for RBC recipients or recipients of male-predominant plasma. The odds ratios (ORs) were 3.2, 1.0, and 0.8, respectively. The OR for all plasma recipients (including group AB female plasma) was 2.0.

The rate of fatalities was higher for AP recipients than RBC recipients, at 0.6 per 106 and 0.2 per 106, respectively (P=0.04).

When the researchers analyzed TRALI cases according to donor, they found a nearly 6-fold predilection for female donors among AP recipients (OR=5.6) and a nearly 5-fold predilection for female donors in RBC recipients (OR=4.5).

The investigators also considered the 41 AP TRALI cases individually to assess how effective a screening program might have been for reducing the risk of TRALI.

In 12 cases, patients had received AP from a male donor. Of the 29 female donors, 26 had reported a prior pregnancy, and 2 had test results suggesting a prior pregnancy.

Of those 28 donors, 3 were negative for HLA antibodies, leaving 25 cases, or 61%, positive for HLA antibodies.

Seventeen of the female donors had HLA class I and II antibodies, including 3 whose donation resulted in a fatality. One had HLA class I only, 2 had HLA class II only, 5 had HLA I or II and a specific human neutrophil antigen (HNA) antibody, and 1 had a specific HNA antibody only.

The researchers evaluated 7 cases in which donors had HLA class I or II antibodies. And they found that all 7 had signal-to-cutoff ratios much higher than any cutoff discussed for screening donors (greater than 100).

“So we predict that a strategy to test female apheresis donors who report prior pregnancy and to defer those with HLA antibodies may reduce the risk of TRALI by about 60% and prevent cases from human neutrophil antibodies as well,” Dr Eder concluded.

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TACO linked to amount and type of blood product transfused

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PHILADELPHIA—Results of a population-based study suggest that elderly adults in the US have seen an increase in the rate of transfusion-associated circulatory overload (TACO) in the last few years.

The risk of TACO increased with advancing age and with increases in the number of units transfused.

TACO rates also appeared to be related to the type of blood components transfused. Patients were more likely to develop TACO if they received red blood cells (RBCs) with plasma and/or platelets.

Mikhail Menis, PharmD, of the Center for Biologics Evaluation and Research at the US Food and Drug Administration in Rockville, Maryland, and his colleagues presented these findings in a poster (SP203) at the AABB Annual Meeting 2014.

The researchers conducted this retrospective, claims-based study to assess TACO occurrence and potential risk factors for the condition among elderly Medicare beneficiaries (aged 65 and older) who were transfused as inpatients from 2011 through 2013.

Among the 6,382,814 inpatient transfusion stays, 4405 included a record of TACO. So the overall rate of TACO was 69.0 per 100,000 stays.

TACO rates (per 100,000) increased significantly over time, from 63.0 in 2011 to 68.0 in 2012 and 77.1 in 2013 (P<0.001).

TACO rates also increased significantly with age—44.5 for patients age 65 to 69, 58.8 for patients age 70 to 74, 66.4 for patients age 75 to 79, 78.7 for patients age 80 to 84, and 91.6 for patients age 85 and older (P<0.001).

Women had a significantly higher rate of TACO than men—76.9 and 58.9, respectively (P<0.001), and whites had a significantly higher rate of TACO than non-whites—73.0 and 49.8, respectively (P<0.001).

In addition, the rate of TACO increased significantly with the number of units transfused. Rates were 30.9 for 1 unit, 63.3 for 2 to 4 units, 103.0 for 5 to 9 units, and 139.8 for more than 9 units (P<0.001).

And TACO rates differed according to the type of blood components transfused. The rate of TACO was 29.2 for patients who received only platelets, 60.8 for those received only plasma, and 73.0 for those who received only RBCs.

The rates were 37.8 for patients who received platelets and plasma; 143.5 for those who received RBCs, plasma, and platelets; 167.9 for those who received RBCs and platelets; and 191.4 for those who received RBCs and plasma.

The researchers noted that this study had its limitations, including potential under-recording or misrecording of transfusion procedures and units, as well as a lack of clinical details to validate TACO diagnoses.

In addition, the rate comparisons were not adjusted for potential confounders, but the researchers are planning to perform adjusted analyses to confirm potential risk factors for TACO in the elderly.

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PHILADELPHIA—Results of a population-based study suggest that elderly adults in the US have seen an increase in the rate of transfusion-associated circulatory overload (TACO) in the last few years.

The risk of TACO increased with advancing age and with increases in the number of units transfused.

TACO rates also appeared to be related to the type of blood components transfused. Patients were more likely to develop TACO if they received red blood cells (RBCs) with plasma and/or platelets.

Mikhail Menis, PharmD, of the Center for Biologics Evaluation and Research at the US Food and Drug Administration in Rockville, Maryland, and his colleagues presented these findings in a poster (SP203) at the AABB Annual Meeting 2014.

The researchers conducted this retrospective, claims-based study to assess TACO occurrence and potential risk factors for the condition among elderly Medicare beneficiaries (aged 65 and older) who were transfused as inpatients from 2011 through 2013.

Among the 6,382,814 inpatient transfusion stays, 4405 included a record of TACO. So the overall rate of TACO was 69.0 per 100,000 stays.

TACO rates (per 100,000) increased significantly over time, from 63.0 in 2011 to 68.0 in 2012 and 77.1 in 2013 (P<0.001).

TACO rates also increased significantly with age—44.5 for patients age 65 to 69, 58.8 for patients age 70 to 74, 66.4 for patients age 75 to 79, 78.7 for patients age 80 to 84, and 91.6 for patients age 85 and older (P<0.001).

Women had a significantly higher rate of TACO than men—76.9 and 58.9, respectively (P<0.001), and whites had a significantly higher rate of TACO than non-whites—73.0 and 49.8, respectively (P<0.001).

In addition, the rate of TACO increased significantly with the number of units transfused. Rates were 30.9 for 1 unit, 63.3 for 2 to 4 units, 103.0 for 5 to 9 units, and 139.8 for more than 9 units (P<0.001).

And TACO rates differed according to the type of blood components transfused. The rate of TACO was 29.2 for patients who received only platelets, 60.8 for those received only plasma, and 73.0 for those who received only RBCs.

The rates were 37.8 for patients who received platelets and plasma; 143.5 for those who received RBCs, plasma, and platelets; 167.9 for those who received RBCs and platelets; and 191.4 for those who received RBCs and plasma.

The researchers noted that this study had its limitations, including potential under-recording or misrecording of transfusion procedures and units, as well as a lack of clinical details to validate TACO diagnoses.

In addition, the rate comparisons were not adjusted for potential confounders, but the researchers are planning to perform adjusted analyses to confirm potential risk factors for TACO in the elderly.

PHILADELPHIA—Results of a population-based study suggest that elderly adults in the US have seen an increase in the rate of transfusion-associated circulatory overload (TACO) in the last few years.

The risk of TACO increased with advancing age and with increases in the number of units transfused.

TACO rates also appeared to be related to the type of blood components transfused. Patients were more likely to develop TACO if they received red blood cells (RBCs) with plasma and/or platelets.

Mikhail Menis, PharmD, of the Center for Biologics Evaluation and Research at the US Food and Drug Administration in Rockville, Maryland, and his colleagues presented these findings in a poster (SP203) at the AABB Annual Meeting 2014.

The researchers conducted this retrospective, claims-based study to assess TACO occurrence and potential risk factors for the condition among elderly Medicare beneficiaries (aged 65 and older) who were transfused as inpatients from 2011 through 2013.

Among the 6,382,814 inpatient transfusion stays, 4405 included a record of TACO. So the overall rate of TACO was 69.0 per 100,000 stays.

TACO rates (per 100,000) increased significantly over time, from 63.0 in 2011 to 68.0 in 2012 and 77.1 in 2013 (P<0.001).

TACO rates also increased significantly with age—44.5 for patients age 65 to 69, 58.8 for patients age 70 to 74, 66.4 for patients age 75 to 79, 78.7 for patients age 80 to 84, and 91.6 for patients age 85 and older (P<0.001).

Women had a significantly higher rate of TACO than men—76.9 and 58.9, respectively (P<0.001), and whites had a significantly higher rate of TACO than non-whites—73.0 and 49.8, respectively (P<0.001).

In addition, the rate of TACO increased significantly with the number of units transfused. Rates were 30.9 for 1 unit, 63.3 for 2 to 4 units, 103.0 for 5 to 9 units, and 139.8 for more than 9 units (P<0.001).

And TACO rates differed according to the type of blood components transfused. The rate of TACO was 29.2 for patients who received only platelets, 60.8 for those received only plasma, and 73.0 for those who received only RBCs.

The rates were 37.8 for patients who received platelets and plasma; 143.5 for those who received RBCs, plasma, and platelets; 167.9 for those who received RBCs and platelets; and 191.4 for those who received RBCs and plasma.

The researchers noted that this study had its limitations, including potential under-recording or misrecording of transfusion procedures and units, as well as a lack of clinical details to validate TACO diagnoses.

In addition, the rate comparisons were not adjusted for potential confounders, but the researchers are planning to perform adjusted analyses to confirm potential risk factors for TACO in the elderly.

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AABB creates new guidelines for platelet transfusion

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Platelets for transfusion

The AABB has developed new guidelines that specify situations

in which adults should receive platelet transfusions.

The group’s

recommendations are based on results of a systematic review.

The

suggestions cover several clinical situations in which platelet

transfusions might be an option, such as therapy-induced hypoproliferative thrombocytopenia, central venous catheter placement, diagnostic lumbar puncture, and cardiac surgery.

To formulate the guidelines, researchers conducted a review of randomized clinical trials and observational studies published from 1900 through September 2014. All studies reported clinical outcomes in patients receiving prophylactic or therapeutic platelet transfusions.

Based on the collected data, the AABB now strongly recommends prophylactic platelet transfusions to reduce the risk for spontaneous bleeding in hospitalized adults with therapy-induced hypoproliferative thrombocytopenia and a platelet count of 10 x 109 cells/L or less. The recommendation states that transfusing 0.5 to 1 apheresis unit is sufficient in these patients.

A weaker recommendation is that prophylactic platelet transfusions be given to patients undergoing elective central venous catheter placement who have a platelet count of less than 20 x 109 cells/L.

Likewise, the AABB says prophylactic transfusions should be given to patients having elective diagnostic lumbar puncture or major elective nonneuraxial surgery who have a platelet count less than 50 x 109 cells/L.

Another weak recommendation advises against routine prophylactic platelet transfusions in patients who are nonthrombocytopenic and have cardiac surgery with cardiopulmonary bypass.

The AABB also suggests (without recommending) that patients with perioperative bleeding and thrombocytopenia or platelet dysfunction may benefit from transfusions.

Finally, the AABB said it cannot recommend for or against platelet transfusions in patients receiving antiplatelet therapy who have intracranial hemorrhage (traumatic or spontaneous).

For more details, see the complete guidelines in Annals of Internal Medicine.

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Platelets for transfusion

The AABB has developed new guidelines that specify situations

in which adults should receive platelet transfusions.

The group’s

recommendations are based on results of a systematic review.

The

suggestions cover several clinical situations in which platelet

transfusions might be an option, such as therapy-induced hypoproliferative thrombocytopenia, central venous catheter placement, diagnostic lumbar puncture, and cardiac surgery.

To formulate the guidelines, researchers conducted a review of randomized clinical trials and observational studies published from 1900 through September 2014. All studies reported clinical outcomes in patients receiving prophylactic or therapeutic platelet transfusions.

Based on the collected data, the AABB now strongly recommends prophylactic platelet transfusions to reduce the risk for spontaneous bleeding in hospitalized adults with therapy-induced hypoproliferative thrombocytopenia and a platelet count of 10 x 109 cells/L or less. The recommendation states that transfusing 0.5 to 1 apheresis unit is sufficient in these patients.

A weaker recommendation is that prophylactic platelet transfusions be given to patients undergoing elective central venous catheter placement who have a platelet count of less than 20 x 109 cells/L.

Likewise, the AABB says prophylactic transfusions should be given to patients having elective diagnostic lumbar puncture or major elective nonneuraxial surgery who have a platelet count less than 50 x 109 cells/L.

Another weak recommendation advises against routine prophylactic platelet transfusions in patients who are nonthrombocytopenic and have cardiac surgery with cardiopulmonary bypass.

The AABB also suggests (without recommending) that patients with perioperative bleeding and thrombocytopenia or platelet dysfunction may benefit from transfusions.

Finally, the AABB said it cannot recommend for or against platelet transfusions in patients receiving antiplatelet therapy who have intracranial hemorrhage (traumatic or spontaneous).

For more details, see the complete guidelines in Annals of Internal Medicine.

Platelets for transfusion

The AABB has developed new guidelines that specify situations

in which adults should receive platelet transfusions.

The group’s

recommendations are based on results of a systematic review.

The

suggestions cover several clinical situations in which platelet

transfusions might be an option, such as therapy-induced hypoproliferative thrombocytopenia, central venous catheter placement, diagnostic lumbar puncture, and cardiac surgery.

To formulate the guidelines, researchers conducted a review of randomized clinical trials and observational studies published from 1900 through September 2014. All studies reported clinical outcomes in patients receiving prophylactic or therapeutic platelet transfusions.

Based on the collected data, the AABB now strongly recommends prophylactic platelet transfusions to reduce the risk for spontaneous bleeding in hospitalized adults with therapy-induced hypoproliferative thrombocytopenia and a platelet count of 10 x 109 cells/L or less. The recommendation states that transfusing 0.5 to 1 apheresis unit is sufficient in these patients.

A weaker recommendation is that prophylactic platelet transfusions be given to patients undergoing elective central venous catheter placement who have a platelet count of less than 20 x 109 cells/L.

Likewise, the AABB says prophylactic transfusions should be given to patients having elective diagnostic lumbar puncture or major elective nonneuraxial surgery who have a platelet count less than 50 x 109 cells/L.

Another weak recommendation advises against routine prophylactic platelet transfusions in patients who are nonthrombocytopenic and have cardiac surgery with cardiopulmonary bypass.

The AABB also suggests (without recommending) that patients with perioperative bleeding and thrombocytopenia or platelet dysfunction may benefit from transfusions.

Finally, the AABB said it cannot recommend for or against platelet transfusions in patients receiving antiplatelet therapy who have intracranial hemorrhage (traumatic or spontaneous).

For more details, see the complete guidelines in Annals of Internal Medicine.

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Malaria prevents hospitals from meeting blood demands

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PHILADELPHIA—The demand for blood transfusions increases substantially during high malaria transmission season, according to a study of hospitals in Tanzania.

On average, blood demand increased about 24% from low transmission season to high transmission season.

And some hospitals could not meet the increased demand. Unmet demand was highest in government hospitals, followed by faith-based institutions and private facilities.

Bakary Drammeh, DrPH, of the Centers for Disease Control and Prevention in Atlanta, Georgia, and his colleagues presented these results in a poster (SP356) at the AABB Annual Meeting 2014.

The researchers analyzed 14,706 blood prescriptions at 42 Tanzanian hospitals—21 government, 9 private, and 12 faith-based institutions.

The team assessed the number of blood prescriptions according to high and low malaria transmission periods—June-July vs August-September.

On average, there were 130 monthly blood prescriptions written per 100 beds during high malaria transmission season and 107 written during low transmission season.

There were 189 and 153 units of blood or blood components requested per 100 beds during high and low seasons, respectively. And there were 159 and 127 units issued, respectively.

Ultimately, an average of 145 units were transfused per 100 beds during high malaria transmission season, and 122 were transfused during low transmission season.

Across all 42 hospitals, total blood prescriptions increased 29% from low malaria transmission season to high transmission season.

The number of units requested increased 26%, the number of units issued increased 34%, and the number of units transfused increased 28%.

So, on average, blood demand increased 23.5% at these 42 hospitals during high malaria transmission season. And some hospitals did not have enough blood to meet demand.

The unmet blood demand was highest in government hospitals, at 25%, compared to faith-based hospitals, at 11%, and private hospitals, at 5%.

The researchers said these results suggest blood services should monitor malaria transmission surveillance reports and revise or project blood collection targets to meet the anticipated demand.

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PHILADELPHIA—The demand for blood transfusions increases substantially during high malaria transmission season, according to a study of hospitals in Tanzania.

On average, blood demand increased about 24% from low transmission season to high transmission season.

And some hospitals could not meet the increased demand. Unmet demand was highest in government hospitals, followed by faith-based institutions and private facilities.

Bakary Drammeh, DrPH, of the Centers for Disease Control and Prevention in Atlanta, Georgia, and his colleagues presented these results in a poster (SP356) at the AABB Annual Meeting 2014.

The researchers analyzed 14,706 blood prescriptions at 42 Tanzanian hospitals—21 government, 9 private, and 12 faith-based institutions.

The team assessed the number of blood prescriptions according to high and low malaria transmission periods—June-July vs August-September.

On average, there were 130 monthly blood prescriptions written per 100 beds during high malaria transmission season and 107 written during low transmission season.

There were 189 and 153 units of blood or blood components requested per 100 beds during high and low seasons, respectively. And there were 159 and 127 units issued, respectively.

Ultimately, an average of 145 units were transfused per 100 beds during high malaria transmission season, and 122 were transfused during low transmission season.

Across all 42 hospitals, total blood prescriptions increased 29% from low malaria transmission season to high transmission season.

The number of units requested increased 26%, the number of units issued increased 34%, and the number of units transfused increased 28%.

So, on average, blood demand increased 23.5% at these 42 hospitals during high malaria transmission season. And some hospitals did not have enough blood to meet demand.

The unmet blood demand was highest in government hospitals, at 25%, compared to faith-based hospitals, at 11%, and private hospitals, at 5%.

The researchers said these results suggest blood services should monitor malaria transmission surveillance reports and revise or project blood collection targets to meet the anticipated demand.

PHILADELPHIA—The demand for blood transfusions increases substantially during high malaria transmission season, according to a study of hospitals in Tanzania.

On average, blood demand increased about 24% from low transmission season to high transmission season.

And some hospitals could not meet the increased demand. Unmet demand was highest in government hospitals, followed by faith-based institutions and private facilities.

Bakary Drammeh, DrPH, of the Centers for Disease Control and Prevention in Atlanta, Georgia, and his colleagues presented these results in a poster (SP356) at the AABB Annual Meeting 2014.

The researchers analyzed 14,706 blood prescriptions at 42 Tanzanian hospitals—21 government, 9 private, and 12 faith-based institutions.

The team assessed the number of blood prescriptions according to high and low malaria transmission periods—June-July vs August-September.

On average, there were 130 monthly blood prescriptions written per 100 beds during high malaria transmission season and 107 written during low transmission season.

There were 189 and 153 units of blood or blood components requested per 100 beds during high and low seasons, respectively. And there were 159 and 127 units issued, respectively.

Ultimately, an average of 145 units were transfused per 100 beds during high malaria transmission season, and 122 were transfused during low transmission season.

Across all 42 hospitals, total blood prescriptions increased 29% from low malaria transmission season to high transmission season.

The number of units requested increased 26%, the number of units issued increased 34%, and the number of units transfused increased 28%.

So, on average, blood demand increased 23.5% at these 42 hospitals during high malaria transmission season. And some hospitals did not have enough blood to meet demand.

The unmet blood demand was highest in government hospitals, at 25%, compared to faith-based hospitals, at 11%, and private hospitals, at 5%.

The researchers said these results suggest blood services should monitor malaria transmission surveillance reports and revise or project blood collection targets to meet the anticipated demand.

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Sugar beets can be used to create hemoglobin

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Sugar beets can be used to create hemoglobin

Nélida Leiva-Eriksson

holding a sugar beet

Credit: Lund University

Biochemists have found evidence to suggest that sugar beets can be used to create a substitute for human hemoglobin.

While studying the genome of the sugar beet, the researchers identified 4 hemoglobin genes—3 non-symbiotic genes (BvHb1.1, BvHb1.2, and BvHb2) and 1 truncated gene (BvHb3).

The team then discovered they could extract hemoglobin from sugar beets using a process that’s about as simple as the one used to extract sugar.

The researchers cloned the hemoglobin genes and inserted them into bacteria, which facilitates their expression and purification.

The group described the gene discovery in Plant and Cell Physiology. Study author Nélida Leiva-Eriksson, a doctoral student at Lund University in Sweden, disclosed additional details in her dissertation. And a short video on the research is available on YouTube.

The researchers discovered that the hemoglobin extracted from sugar beets is almost identical to human hemoglobin, especially the form of hemoglobin in the brain.

“There is a difference in a small detail on the surface of the protein, but this simply appears to extend the lifespan of the hemoglobin from sugar beet, which is good news,” Leiva-Eriksson said.

On the other hand, sugar beet hemoglobin has a completely different function from human hemoglobin.

“We have found that the hemoglobin in the plant binds nitric oxide,” Leiva-Eriksson said. “It is probably needed to keep certain processes in check, for example, so that the nitric oxide doesn’t become toxic, and to ward off bacteria.”

The researchers are planning to start testing the sugar beet hemoglobin in animal experiments in just over a year.

The team said there is good reason to think hemoglobin derived from sugar beets and other crops could become a realistic alternative to human hemoglobin.

“From 1 hectare, we could produce 1 to 2 tons of hemoglobin,” said Leif Bülow, PhD, of Lund University, “which could save thousands of lives.”

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Nélida Leiva-Eriksson

holding a sugar beet

Credit: Lund University

Biochemists have found evidence to suggest that sugar beets can be used to create a substitute for human hemoglobin.

While studying the genome of the sugar beet, the researchers identified 4 hemoglobin genes—3 non-symbiotic genes (BvHb1.1, BvHb1.2, and BvHb2) and 1 truncated gene (BvHb3).

The team then discovered they could extract hemoglobin from sugar beets using a process that’s about as simple as the one used to extract sugar.

The researchers cloned the hemoglobin genes and inserted them into bacteria, which facilitates their expression and purification.

The group described the gene discovery in Plant and Cell Physiology. Study author Nélida Leiva-Eriksson, a doctoral student at Lund University in Sweden, disclosed additional details in her dissertation. And a short video on the research is available on YouTube.

The researchers discovered that the hemoglobin extracted from sugar beets is almost identical to human hemoglobin, especially the form of hemoglobin in the brain.

“There is a difference in a small detail on the surface of the protein, but this simply appears to extend the lifespan of the hemoglobin from sugar beet, which is good news,” Leiva-Eriksson said.

On the other hand, sugar beet hemoglobin has a completely different function from human hemoglobin.

“We have found that the hemoglobin in the plant binds nitric oxide,” Leiva-Eriksson said. “It is probably needed to keep certain processes in check, for example, so that the nitric oxide doesn’t become toxic, and to ward off bacteria.”

The researchers are planning to start testing the sugar beet hemoglobin in animal experiments in just over a year.

The team said there is good reason to think hemoglobin derived from sugar beets and other crops could become a realistic alternative to human hemoglobin.

“From 1 hectare, we could produce 1 to 2 tons of hemoglobin,” said Leif Bülow, PhD, of Lund University, “which could save thousands of lives.”

Nélida Leiva-Eriksson

holding a sugar beet

Credit: Lund University

Biochemists have found evidence to suggest that sugar beets can be used to create a substitute for human hemoglobin.

While studying the genome of the sugar beet, the researchers identified 4 hemoglobin genes—3 non-symbiotic genes (BvHb1.1, BvHb1.2, and BvHb2) and 1 truncated gene (BvHb3).

The team then discovered they could extract hemoglobin from sugar beets using a process that’s about as simple as the one used to extract sugar.

The researchers cloned the hemoglobin genes and inserted them into bacteria, which facilitates their expression and purification.

The group described the gene discovery in Plant and Cell Physiology. Study author Nélida Leiva-Eriksson, a doctoral student at Lund University in Sweden, disclosed additional details in her dissertation. And a short video on the research is available on YouTube.

The researchers discovered that the hemoglobin extracted from sugar beets is almost identical to human hemoglobin, especially the form of hemoglobin in the brain.

“There is a difference in a small detail on the surface of the protein, but this simply appears to extend the lifespan of the hemoglobin from sugar beet, which is good news,” Leiva-Eriksson said.

On the other hand, sugar beet hemoglobin has a completely different function from human hemoglobin.

“We have found that the hemoglobin in the plant binds nitric oxide,” Leiva-Eriksson said. “It is probably needed to keep certain processes in check, for example, so that the nitric oxide doesn’t become toxic, and to ward off bacteria.”

The researchers are planning to start testing the sugar beet hemoglobin in animal experiments in just over a year.

The team said there is good reason to think hemoglobin derived from sugar beets and other crops could become a realistic alternative to human hemoglobin.

“From 1 hectare, we could produce 1 to 2 tons of hemoglobin,” said Leif Bülow, PhD, of Lund University, “which could save thousands of lives.”

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