Blood Banking

Blood for transfusion

Photo by Elise Amendola

Results of a single-center study seem to support the use of tranexamic acid (TXA) in all eligible patients undergoing hip or knee replacement.

By giving TXA to every eligible patient undergoing hip or knee arthroplasty, a Canadian hospital significantly reduced its use of red blood cell transfusions during these surgeries without increasing the incidence of adverse events or the patients’ length of hospital stay.

The results were published in the Canadian Journal of Anesthesia.

TXA is known to prevent excessive blood loss during surgeries and has proven effective in orthopedic, trauma, and cardiac patients.

However, a few years ago, less than half of eligible patients at St. Michael’s Hospital in Toronto, Ontario, were receiving TXA because of a province-wide shortage. The drug was given only to patients at high risk of requiring a blood transfusion.

The TXA shortage ended in early 2013 and, in October 2013, St. Michael’s implemented a protocol to facilitate universal administration of TXA in patients undergoing total hip or knee arthroplasty.

“We wanted to optimize TXA’s use in patients undergoing hip or knee replacements because these procedures often result in high blood loss and frequently require transfusions,” said study author Greg Hare, MD, PhD, an anesthesiologist at St. Michael’s.

“The drug costs about $10 per patient, while the average cost of transfusing one unit of blood is $1200.”

So every eligible patient undergoing hip or knee replacement received TXA at 20 mg/kg⁻¹. The drug was not used in patients considered at risk of thromboembolic events, stroke, or any other cardiovascular issues.

A total of 402 patients received the drug from October 21, 2013, to April 30, 2014. The researchers compared this group of patients to a group of 422 hip/knee replacement patients treated before the universal administration protocol was implemented (when TXA was given to high-risk patients only).

As expected, there was a significant increase in TXA use post-protocol, from 45.8% to 95.3% (P<0.001). And the rate of red blood cell transfusions decreased from 8.8% to 5.2% (P=0.043).

There was no significant difference in mean preoperative hemoglobin (Hb) levels between the pre- and post-protocol groups—133 g/L^-1 and 135 g/L^-1, respectively (P=0.073).

But there was a significant increase in Hb in the post-protocol group on days 1 and 3 after surgery. On day 1, the mean Hb was 108 g/L^-1 in the pre-protocol group and 112 g/L^-1 in the post-protocol group (P<0.001). On day 3, the mean Hb was 97 g/L^-1 and 101 g/L^-1, respectively (P<0.001).

There was no significant difference between the groups with regard to length of hospital stay. The mean length of stay was 3.93 days pre-protocol and 3.87 days post-protocol (P=0.652).

The adverse events assessed were death, myocardial infarction (MI), stroke, seizure, pulmonary embolism (PE), deep vein thrombosis (DVT), and acute kidney injury (AKI).

There were 13 such events in the pre-protocol group, including 1 MI, 3 PEs, and 9 AKIs. And there were 19 such events in the post-protocol group, including 1 MI, 1 DVT, 1 PE, and 16 AKIs (P=0.368 for all events and P=0.223 for AKIs).

Because TXA decreased the use of transfusions without increasing the rate of adverse events, Dr Hare and his colleagues consider their universal administration protocol a success.

“Making TXA mandatory for eligible patients has made care more efficient, ensuring the best possible care for our patients,” Dr Hare said.

“Other hospitals and surgical centers should consider making TXA mandatory for similar surgeries because it can improve quality of care, decrease the need for blood transfusions, and even save money.”

Blood for transfusion

Photo by Elise Amendola

Results of a single-center study seem to support the use of tranexamic acid (TXA) in all eligible patients undergoing hip or knee replacement.

By giving TXA to every eligible patient undergoing hip or knee arthroplasty, a Canadian hospital significantly reduced its use of red blood cell transfusions during these surgeries without increasing the incidence of adverse events or the patients’ length of hospital stay.

The results were published in the Canadian Journal of Anesthesia.

TXA is known to prevent excessive blood loss during surgeries and has proven effective in orthopedic, trauma, and cardiac patients.

However, a few years ago, less than half of eligible patients at St. Michael’s Hospital in Toronto, Ontario, were receiving TXA because of a province-wide shortage. The drug was given only to patients at high risk of requiring a blood transfusion.

The TXA shortage ended in early 2013 and, in October 2013, St. Michael’s implemented a protocol to facilitate universal administration of TXA in patients undergoing total hip or knee arthroplasty.

“We wanted to optimize TXA’s use in patients undergoing hip or knee replacements because these procedures often result in high blood loss and frequently require transfusions,” said study author Greg Hare, MD, PhD, an anesthesiologist at St. Michael’s.

“The drug costs about $10 per patient, while the average cost of transfusing one unit of blood is $1200.”

So every eligible patient undergoing hip or knee replacement received TXA at 20 mg/kg⁻¹. The drug was not used in patients considered at risk of thromboembolic events, stroke, or any other cardiovascular issues.

A total of 402 patients received the drug from October 21, 2013, to April 30, 2014. The researchers compared this group of patients to a group of 422 hip/knee replacement patients treated before the universal administration protocol was implemented (when TXA was given to high-risk patients only).

As expected, there was a significant increase in TXA use post-protocol, from 45.8% to 95.3% (P<0.001). And the rate of red blood cell transfusions decreased from 8.8% to 5.2% (P=0.043).

There was no significant difference in mean preoperative hemoglobin (Hb) levels between the pre- and post-protocol groups—133 g/L^-1 and 135 g/L^-1, respectively (P=0.073).

But there was a significant increase in Hb in the post-protocol group on days 1 and 3 after surgery. On day 1, the mean Hb was 108 g/L^-1 in the pre-protocol group and 112 g/L^-1 in the post-protocol group (P<0.001). On day 3, the mean Hb was 97 g/L^-1 and 101 g/L^-1, respectively (P<0.001).

There was no significant difference between the groups with regard to length of hospital stay. The mean length of stay was 3.93 days pre-protocol and 3.87 days post-protocol (P=0.652).

The adverse events assessed were death, myocardial infarction (MI), stroke, seizure, pulmonary embolism (PE), deep vein thrombosis (DVT), and acute kidney injury (AKI).

There were 13 such events in the pre-protocol group, including 1 MI, 3 PEs, and 9 AKIs. And there were 19 such events in the post-protocol group, including 1 MI, 1 DVT, 1 PE, and 16 AKIs (P=0.368 for all events and P=0.223 for AKIs).

Because TXA decreased the use of transfusions without increasing the rate of adverse events, Dr Hare and his colleagues consider their universal administration protocol a success.

“Making TXA mandatory for eligible patients has made care more efficient, ensuring the best possible care for our patients,” Dr Hare said.

“Other hospitals and surgical centers should consider making TXA mandatory for similar surgeries because it can improve quality of care, decrease the need for blood transfusions, and even save money.”

Blood for transfusion

Photo by Elise Amendola

Results of a single-center study seem to support the use of tranexamic acid (TXA) in all eligible patients undergoing hip or knee replacement.

By giving TXA to every eligible patient undergoing hip or knee arthroplasty, a Canadian hospital significantly reduced its use of red blood cell transfusions during these surgeries without increasing the incidence of adverse events or the patients’ length of hospital stay.

The results were published in the Canadian Journal of Anesthesia.

TXA is known to prevent excessive blood loss during surgeries and has proven effective in orthopedic, trauma, and cardiac patients.

However, a few years ago, less than half of eligible patients at St. Michael’s Hospital in Toronto, Ontario, were receiving TXA because of a province-wide shortage. The drug was given only to patients at high risk of requiring a blood transfusion.

The TXA shortage ended in early 2013 and, in October 2013, St. Michael’s implemented a protocol to facilitate universal administration of TXA in patients undergoing total hip or knee arthroplasty.

“We wanted to optimize TXA’s use in patients undergoing hip or knee replacements because these procedures often result in high blood loss and frequently require transfusions,” said study author Greg Hare, MD, PhD, an anesthesiologist at St. Michael’s.

“The drug costs about $10 per patient, while the average cost of transfusing one unit of blood is $1200.”

So every eligible patient undergoing hip or knee replacement received TXA at 20 mg/kg⁻¹. The drug was not used in patients considered at risk of thromboembolic events, stroke, or any other cardiovascular issues.

A total of 402 patients received the drug from October 21, 2013, to April 30, 2014. The researchers compared this group of patients to a group of 422 hip/knee replacement patients treated before the universal administration protocol was implemented (when TXA was given to high-risk patients only).

As expected, there was a significant increase in TXA use post-protocol, from 45.8% to 95.3% (P<0.001). And the rate of red blood cell transfusions decreased from 8.8% to 5.2% (P=0.043).

There was no significant difference in mean preoperative hemoglobin (Hb) levels between the pre- and post-protocol groups—133 g/L^-1 and 135 g/L^-1, respectively (P=0.073).

But there was a significant increase in Hb in the post-protocol group on days 1 and 3 after surgery. On day 1, the mean Hb was 108 g/L^-1 in the pre-protocol group and 112 g/L^-1 in the post-protocol group (P<0.001). On day 3, the mean Hb was 97 g/L^-1 and 101 g/L^-1, respectively (P<0.001).

There was no significant difference between the groups with regard to length of hospital stay. The mean length of stay was 3.93 days pre-protocol and 3.87 days post-protocol (P=0.652).

The adverse events assessed were death, myocardial infarction (MI), stroke, seizure, pulmonary embolism (PE), deep vein thrombosis (DVT), and acute kidney injury (AKI).

There were 13 such events in the pre-protocol group, including 1 MI, 3 PEs, and 9 AKIs. And there were 19 such events in the post-protocol group, including 1 MI, 1 DVT, 1 PE, and 16 AKIs (P=0.368 for all events and P=0.223 for AKIs).

Because TXA decreased the use of transfusions without increasing the rate of adverse events, Dr Hare and his colleagues consider their universal administration protocol a success.

“Making TXA mandatory for eligible patients has made care more efficient, ensuring the best possible care for our patients,” Dr Hare said.

“Other hospitals and surgical centers should consider making TXA mandatory for similar surgeries because it can improve quality of care, decrease the need for blood transfusions, and even save money.”

ORTHO VISION™ Analyzer

Photo courtesy of

Ortho Clinical Diagnostics

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the ORTHO VISION^TM Analyzer, a system that automates in vitro testing of human blood.

The system is now commercially available in the US and Puerto Rico.

The ORTHO VISION Analyzer automates test processing functions, including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading, and interpretation and data management requirements using ID-MTS Gel Cards and digital image processing.

Tests that can be performed with the system include:

• ABO/Rh/grouping
• ABO/Rh confirmation
• Antibody screen
• Antibody identification
• Selected cell panel
• Rh phenotype (C,c,E,e)
• Donor confirmation
• Crossmatch (AHG)
• Antigen typing
• Serial dilutions for titration studies
• DAT (polyspecific)
• DAT (IGG)
• Cord blood testing

The system can be used as a standalone instrument or interfaced to a laboratory information system.

The ORTHO VISION Analyzer was designed with secure monitoring technologies for safety checks and balances, and it allows transfusion medicine professionals to track steps in the immunohematology testing process.

Through Ortho Clinical Diagnostics’ proprietary Intellicheck Technology, the ORTHO VISION Analyzer verifies and documents diagnostic checks throughout the testing process, while e-Connectivity Technology provides 24/7 remote data tracking that monitors instrument performance while maximizing uptime. Laboratory personnel can log on anytime, anywhere to collaborate on interpreting results in real time.

“With the launch of the ORTHO VISION Analyzer, our goal is to help improve the safety of blood transfusions by reducing the lab’s reliance on manual methods,” said Robert Yates, chief operating officer of Ortho Clinical Diagnostics, the company developing the ORTHO VISION Analyzer.

A version of the ORTHO VISION Analyzer is already commercially available in Europe, Japan, Latin America, Canada, and Australia.

For more information on the system, visit the Ortho Clinical Diagnostics website.

ORTHO VISION™ Analyzer

Photo courtesy of

Ortho Clinical Diagnostics

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the ORTHO VISION^TM Analyzer, a system that automates in vitro testing of human blood.

The system is now commercially available in the US and Puerto Rico.

The ORTHO VISION Analyzer automates test processing functions, including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading, and interpretation and data management requirements using ID-MTS Gel Cards and digital image processing.

Tests that can be performed with the system include:

• ABO/Rh/grouping
• ABO/Rh confirmation
• Antibody screen
• Antibody identification
• Selected cell panel
• Rh phenotype (C,c,E,e)
• Donor confirmation
• Crossmatch (AHG)
• Antigen typing
• Serial dilutions for titration studies
• DAT (polyspecific)
• DAT (IGG)
• Cord blood testing

The system can be used as a standalone instrument or interfaced to a laboratory information system.

The ORTHO VISION Analyzer was designed with secure monitoring technologies for safety checks and balances, and it allows transfusion medicine professionals to track steps in the immunohematology testing process.

Through Ortho Clinical Diagnostics’ proprietary Intellicheck Technology, the ORTHO VISION Analyzer verifies and documents diagnostic checks throughout the testing process, while e-Connectivity Technology provides 24/7 remote data tracking that monitors instrument performance while maximizing uptime. Laboratory personnel can log on anytime, anywhere to collaborate on interpreting results in real time.

“With the launch of the ORTHO VISION Analyzer, our goal is to help improve the safety of blood transfusions by reducing the lab’s reliance on manual methods,” said Robert Yates, chief operating officer of Ortho Clinical Diagnostics, the company developing the ORTHO VISION Analyzer.

A version of the ORTHO VISION Analyzer is already commercially available in Europe, Japan, Latin America, Canada, and Australia.

For more information on the system, visit the Ortho Clinical Diagnostics website.

ORTHO VISION™ Analyzer

Photo courtesy of

Ortho Clinical Diagnostics

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the ORTHO VISION^TM Analyzer, a system that automates in vitro testing of human blood.

The system is now commercially available in the US and Puerto Rico.

The ORTHO VISION Analyzer automates test processing functions, including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading, and interpretation and data management requirements using ID-MTS Gel Cards and digital image processing.

Tests that can be performed with the system include:

• ABO/Rh/grouping
• ABO/Rh confirmation
• Antibody screen
• Antibody identification
• Selected cell panel
• Rh phenotype (C,c,E,e)
• Donor confirmation
• Crossmatch (AHG)
• Antigen typing
• Serial dilutions for titration studies
• DAT (polyspecific)
• DAT (IGG)
• Cord blood testing

The system can be used as a standalone instrument or interfaced to a laboratory information system.

The ORTHO VISION Analyzer was designed with secure monitoring technologies for safety checks and balances, and it allows transfusion medicine professionals to track steps in the immunohematology testing process.

Through Ortho Clinical Diagnostics’ proprietary Intellicheck Technology, the ORTHO VISION Analyzer verifies and documents diagnostic checks throughout the testing process, while e-Connectivity Technology provides 24/7 remote data tracking that monitors instrument performance while maximizing uptime. Laboratory personnel can log on anytime, anywhere to collaborate on interpreting results in real time.

“With the launch of the ORTHO VISION Analyzer, our goal is to help improve the safety of blood transfusions by reducing the lab’s reliance on manual methods,” said Robert Yates, chief operating officer of Ortho Clinical Diagnostics, the company developing the ORTHO VISION Analyzer.

A version of the ORTHO VISION Analyzer is already commercially available in Europe, Japan, Latin America, Canada, and Australia.

For more information on the system, visit the Ortho Clinical Diagnostics website.

Blood collection

Photo by Charles Haymond

The US Food and Drug Administration (FDA) has cleared a labeling change for the Terumo BCT Trima Accel Automated Blood Collection System.

The change means platelets in plasma that are collected via this system can now be stored for 7 days instead of 5, but the blood products must be tested for bacterial contamination.

The label change also allows for use of a wireless feature designed to enhance the mobility and flexibility of the system.

The Trima Accel system includes the Trima Accel device, a tubing set, and Trima Accel software. The system uses a centrifuge to separate whole blood into platelets, plasma, and red blood cells. It then collects the components based on customer-configured priorities and the donor’s physiology and blood count.

Platelet storage

The FDA is now allowing platelets in 100% plasma that are collected via the Trima Accel system to be stored for up to 7 days post-collection. But platelets in isoplate solution can only be stored for up to 5 days.

For platelet storage up to 7 days, the FDA requires that every product be tested with a bacterial detection device cleared by the FDA and labeled as a “safety measure.”

Wireless feature

The newly cleared wireless feature connects the Trima Accel system to software applications such as the Cadence Data Collection System or the Vista Information System through the blood center’s or hospital’s existing wireless network.

This enables access to electronic donor information and reporting capabilities, with the goals of streamlining collections, simplifying data management, and allowing operators to focus on donor care, even when a wired connection is unavailable.

The wireless feature enables blood centers to either purchase a compatible wireless appliance from Terumo BCT or choose an appliance of their own for attachment to the Trima Accel system using a mounting bracket on the back of the system.

Blood collection

Photo by Charles Haymond

The US Food and Drug Administration (FDA) has cleared a labeling change for the Terumo BCT Trima Accel Automated Blood Collection System.

The change means platelets in plasma that are collected via this system can now be stored for 7 days instead of 5, but the blood products must be tested for bacterial contamination.

The label change also allows for use of a wireless feature designed to enhance the mobility and flexibility of the system.

The Trima Accel system includes the Trima Accel device, a tubing set, and Trima Accel software. The system uses a centrifuge to separate whole blood into platelets, plasma, and red blood cells. It then collects the components based on customer-configured priorities and the donor’s physiology and blood count.

Platelet storage

The FDA is now allowing platelets in 100% plasma that are collected via the Trima Accel system to be stored for up to 7 days post-collection. But platelets in isoplate solution can only be stored for up to 5 days.

For platelet storage up to 7 days, the FDA requires that every product be tested with a bacterial detection device cleared by the FDA and labeled as a “safety measure.”

Wireless feature

The newly cleared wireless feature connects the Trima Accel system to software applications such as the Cadence Data Collection System or the Vista Information System through the blood center’s or hospital’s existing wireless network.

This enables access to electronic donor information and reporting capabilities, with the goals of streamlining collections, simplifying data management, and allowing operators to focus on donor care, even when a wired connection is unavailable.

The wireless feature enables blood centers to either purchase a compatible wireless appliance from Terumo BCT or choose an appliance of their own for attachment to the Trima Accel system using a mounting bracket on the back of the system.

Blood collection

Photo by Charles Haymond

The US Food and Drug Administration (FDA) has cleared a labeling change for the Terumo BCT Trima Accel Automated Blood Collection System.

The change means platelets in plasma that are collected via this system can now be stored for 7 days instead of 5, but the blood products must be tested for bacterial contamination.

The label change also allows for use of a wireless feature designed to enhance the mobility and flexibility of the system.

The Trima Accel system includes the Trima Accel device, a tubing set, and Trima Accel software. The system uses a centrifuge to separate whole blood into platelets, plasma, and red blood cells. It then collects the components based on customer-configured priorities and the donor’s physiology and blood count.

Platelet storage

The FDA is now allowing platelets in 100% plasma that are collected via the Trima Accel system to be stored for up to 7 days post-collection. But platelets in isoplate solution can only be stored for up to 5 days.

For platelet storage up to 7 days, the FDA requires that every product be tested with a bacterial detection device cleared by the FDA and labeled as a “safety measure.”

Wireless feature

The newly cleared wireless feature connects the Trima Accel system to software applications such as the Cadence Data Collection System or the Vista Information System through the blood center’s or hospital’s existing wireless network.

This enables access to electronic donor information and reporting capabilities, with the goals of streamlining collections, simplifying data management, and allowing operators to focus on donor care, even when a wired connection is unavailable.

The wireless feature enables blood centers to either purchase a compatible wireless appliance from Terumo BCT or choose an appliance of their own for attachment to the Trima Accel system using a mounting bracket on the back of the system.

Platelets for transfusion

The US Food and Drug Administration (FDA) has cleared a label change for the Fenwal Amicus system, a cell-separation device, to allow for 7-day storage of platelets collected via this system.

The Fenwal Amicus system is used to collect platelets, platelets with concurrent plasma and red cells, and mononuclear cells.

The label change means platelets collected via the Fenwal Amicus system can now be stored for 7 days instead of 5, but conditions apply.

“Our customers now have the ability to store and use 7-day platelets processed by Amicus to help meet an important need in transfusion medicine,” said Dean Gregory, of Fresenius Kabi North America, the company that manufactures the Fenwal Amicus system.

“We designed Amicus to help optimize apheresis programs for blood-collection professionals. With this new clearance, the Amicus system becomes an even more versatile choice.”

Previously, platelets were limited to a shelf life of 5 days due to the absence of appropriate bacterial testing methods and appropriate instructions for use.

The label change for the Fenwal Amicus system means blood centers that want to store apheresis-derived platelets for 7 days must label every product with a statement that the product must be tested with a bacterial detection device cleared by the FDA and labeled as a “safety measure.”

To support this requirement, Fresenius Kabi distributes the Verax Platelet PGD test, a rapid platelet PGD test that is cleared by the FDA as a “safety measure” for use in leukoreduced apheresis platelets 24 hours prior to transfusion.

For more information on the Verax Platelet PGD test, visit the Verax Biomedical website. For more information on the Fenwal Amicus system, visit the Fenwal website.

Platelets for transfusion

The US Food and Drug Administration (FDA) has cleared a label change for the Fenwal Amicus system, a cell-separation device, to allow for 7-day storage of platelets collected via this system.

The Fenwal Amicus system is used to collect platelets, platelets with concurrent plasma and red cells, and mononuclear cells.

The label change means platelets collected via the Fenwal Amicus system can now be stored for 7 days instead of 5, but conditions apply.

“Our customers now have the ability to store and use 7-day platelets processed by Amicus to help meet an important need in transfusion medicine,” said Dean Gregory, of Fresenius Kabi North America, the company that manufactures the Fenwal Amicus system.

“We designed Amicus to help optimize apheresis programs for blood-collection professionals. With this new clearance, the Amicus system becomes an even more versatile choice.”

Previously, platelets were limited to a shelf life of 5 days due to the absence of appropriate bacterial testing methods and appropriate instructions for use.

The label change for the Fenwal Amicus system means blood centers that want to store apheresis-derived platelets for 7 days must label every product with a statement that the product must be tested with a bacterial detection device cleared by the FDA and labeled as a “safety measure.”

To support this requirement, Fresenius Kabi distributes the Verax Platelet PGD test, a rapid platelet PGD test that is cleared by the FDA as a “safety measure” for use in leukoreduced apheresis platelets 24 hours prior to transfusion.

For more information on the Verax Platelet PGD test, visit the Verax Biomedical website. For more information on the Fenwal Amicus system, visit the Fenwal website.

Platelets for transfusion

The US Food and Drug Administration (FDA) has cleared a label change for the Fenwal Amicus system, a cell-separation device, to allow for 7-day storage of platelets collected via this system.

The Fenwal Amicus system is used to collect platelets, platelets with concurrent plasma and red cells, and mononuclear cells.

The label change means platelets collected via the Fenwal Amicus system can now be stored for 7 days instead of 5, but conditions apply.

“Our customers now have the ability to store and use 7-day platelets processed by Amicus to help meet an important need in transfusion medicine,” said Dean Gregory, of Fresenius Kabi North America, the company that manufactures the Fenwal Amicus system.

“We designed Amicus to help optimize apheresis programs for blood-collection professionals. With this new clearance, the Amicus system becomes an even more versatile choice.”

Previously, platelets were limited to a shelf life of 5 days due to the absence of appropriate bacterial testing methods and appropriate instructions for use.

The label change for the Fenwal Amicus system means blood centers that want to store apheresis-derived platelets for 7 days must label every product with a statement that the product must be tested with a bacterial detection device cleared by the FDA and labeled as a “safety measure.”

To support this requirement, Fresenius Kabi distributes the Verax Platelet PGD test, a rapid platelet PGD test that is cleared by the FDA as a “safety measure” for use in leukoreduced apheresis platelets 24 hours prior to transfusion.

For more information on the Verax Platelet PGD test, visit the Verax Biomedical website. For more information on the Fenwal Amicus system, visit the Fenwal website.

Blood for transfusion

Photo by Elise Amendola

Results of a pilot study suggest a restrictive transfusion strategy may be safe for patients with acute upper gastrointestinal bleeding (AUGIB), but investigators say more research is needed.

In this study, known as TRIGGER, use of a restrictive transfusion strategy led to a 13% reduction in red blood cell (RBC) transfusions compared to the liberal strategy, but this difference was not statistically significant.

Likewise, there was no significant difference in clinical outcomes whether AUGIB patients received transfusions according to the restrictive strategy or the liberal one.

These results suggest a need for a large, randomized trial, according to investigators.

“If restrictive practice is proven to be safe in a large study, it could potentially safely reduce the use of red blood cell transfusions and produce cost savings . . . ,” said Vipul Jairath, MBChB, DPhil, of Oxford University Hospitals in the UK.

He and his colleagues conducted the TRIGGER trial and reported the results in The Lancet.

The study included 6 hospitals that had more than 20 AUGIB admissions monthly, more than 400 adult beds, 24-hour endoscopy, and onsite intensive care and surgery. Patients were eligible if they presented with new AUGIB (defined by hematemesis or melena) and were 18 or older. The only exclusion criterion was exsanguinating hemorrhage.

The investigators enrolled 936 patients—403 on the restrictive transfusion arm and 533 on the liberal arm. Patients in the restrictive arm were eligible to receive RBCs when their hemoglobin concentration fell below 80 g/L, with a post-transfusion target of 81-100 g/L.

Patients in the liberal arm were eligible for transfusion when their hemoglobin concentration fell below 100 g/L, with a post-transfusion target of 101-120 g/L. These thresholds were informed by UK transfusion practices.

Protocol adherence was 96% in the restrictive arm and 83% in the liberal arm. The mean last recorded hemoglobin concentration was 116 g/L for the restrictive arm and 118 g/L for the liberal arm.

The investigators noted that there was a 13% absolute reduction in the proportion of patients transfused in the restrictive arm, a reduction in the amount of RBCs transfused between the arms, and a separation in hemoglobin concentration between the arms, but none of these differences were significant.

In addition, there was no significant difference in clinical outcomes between the arms, although the trial was not powered to assess these outcomes.

All-cause mortality at day 28 was 7% in the liberal transfusion arm and 5% in the restrictive arm. The rate of serious adverse events at day 28 was 22% and 18%, respectively.

At hospital discharge, further bleeding had occurred in 6% of patients in the liberal arm and 4% in the restrictive arm. At day 28, further bleeding had occurred in 9% and 5%, respectively.

At discharge, thromboembolic or ischemic events had occurred in 5% of patients in the liberal arm and 3% in the restrictive arm. At day 28, these events had occurred in 7% and 4%, respectively.

At discharge, acute transfusion reactions had occurred in 2% of patients in the liberal arm and 1% in the restrictive arm, and infections had occurred in 24% and 26%, respectively.

By discharge, 38% of patients in the liberal arm and 32% in the restrictive arm had required some therapeutic intervention. Surgical or radiological intervention was required in 3% and 4%, respectively.

Considering these results, the investigators said the TRIGGER trial has paved the way for a phase 3 trial that could provide evidence to inform transfusion guidelines for patients with AUGIB.

Blood for transfusion

Photo by Elise Amendola

Results of a pilot study suggest a restrictive transfusion strategy may be safe for patients with acute upper gastrointestinal bleeding (AUGIB), but investigators say more research is needed.

In this study, known as TRIGGER, use of a restrictive transfusion strategy led to a 13% reduction in red blood cell (RBC) transfusions compared to the liberal strategy, but this difference was not statistically significant.

Likewise, there was no significant difference in clinical outcomes whether AUGIB patients received transfusions according to the restrictive strategy or the liberal one.

These results suggest a need for a large, randomized trial, according to investigators.

“If restrictive practice is proven to be safe in a large study, it could potentially safely reduce the use of red blood cell transfusions and produce cost savings . . . ,” said Vipul Jairath, MBChB, DPhil, of Oxford University Hospitals in the UK.

He and his colleagues conducted the TRIGGER trial and reported the results in The Lancet.

The study included 6 hospitals that had more than 20 AUGIB admissions monthly, more than 400 adult beds, 24-hour endoscopy, and onsite intensive care and surgery. Patients were eligible if they presented with new AUGIB (defined by hematemesis or melena) and were 18 or older. The only exclusion criterion was exsanguinating hemorrhage.

The investigators enrolled 936 patients—403 on the restrictive transfusion arm and 533 on the liberal arm. Patients in the restrictive arm were eligible to receive RBCs when their hemoglobin concentration fell below 80 g/L, with a post-transfusion target of 81-100 g/L.

Patients in the liberal arm were eligible for transfusion when their hemoglobin concentration fell below 100 g/L, with a post-transfusion target of 101-120 g/L. These thresholds were informed by UK transfusion practices.

Protocol adherence was 96% in the restrictive arm and 83% in the liberal arm. The mean last recorded hemoglobin concentration was 116 g/L for the restrictive arm and 118 g/L for the liberal arm.

The investigators noted that there was a 13% absolute reduction in the proportion of patients transfused in the restrictive arm, a reduction in the amount of RBCs transfused between the arms, and a separation in hemoglobin concentration between the arms, but none of these differences were significant.

In addition, there was no significant difference in clinical outcomes between the arms, although the trial was not powered to assess these outcomes.

All-cause mortality at day 28 was 7% in the liberal transfusion arm and 5% in the restrictive arm. The rate of serious adverse events at day 28 was 22% and 18%, respectively.

At hospital discharge, further bleeding had occurred in 6% of patients in the liberal arm and 4% in the restrictive arm. At day 28, further bleeding had occurred in 9% and 5%, respectively.

At discharge, thromboembolic or ischemic events had occurred in 5% of patients in the liberal arm and 3% in the restrictive arm. At day 28, these events had occurred in 7% and 4%, respectively.

At discharge, acute transfusion reactions had occurred in 2% of patients in the liberal arm and 1% in the restrictive arm, and infections had occurred in 24% and 26%, respectively.

By discharge, 38% of patients in the liberal arm and 32% in the restrictive arm had required some therapeutic intervention. Surgical or radiological intervention was required in 3% and 4%, respectively.

Considering these results, the investigators said the TRIGGER trial has paved the way for a phase 3 trial that could provide evidence to inform transfusion guidelines for patients with AUGIB.

Blood for transfusion

Photo by Elise Amendola

Results of a pilot study suggest a restrictive transfusion strategy may be safe for patients with acute upper gastrointestinal bleeding (AUGIB), but investigators say more research is needed.

In this study, known as TRIGGER, use of a restrictive transfusion strategy led to a 13% reduction in red blood cell (RBC) transfusions compared to the liberal strategy, but this difference was not statistically significant.

Likewise, there was no significant difference in clinical outcomes whether AUGIB patients received transfusions according to the restrictive strategy or the liberal one.

These results suggest a need for a large, randomized trial, according to investigators.

“If restrictive practice is proven to be safe in a large study, it could potentially safely reduce the use of red blood cell transfusions and produce cost savings . . . ,” said Vipul Jairath, MBChB, DPhil, of Oxford University Hospitals in the UK.

He and his colleagues conducted the TRIGGER trial and reported the results in The Lancet.

The study included 6 hospitals that had more than 20 AUGIB admissions monthly, more than 400 adult beds, 24-hour endoscopy, and onsite intensive care and surgery. Patients were eligible if they presented with new AUGIB (defined by hematemesis or melena) and were 18 or older. The only exclusion criterion was exsanguinating hemorrhage.

The investigators enrolled 936 patients—403 on the restrictive transfusion arm and 533 on the liberal arm. Patients in the restrictive arm were eligible to receive RBCs when their hemoglobin concentration fell below 80 g/L, with a post-transfusion target of 81-100 g/L.

Patients in the liberal arm were eligible for transfusion when their hemoglobin concentration fell below 100 g/L, with a post-transfusion target of 101-120 g/L. These thresholds were informed by UK transfusion practices.

Protocol adherence was 96% in the restrictive arm and 83% in the liberal arm. The mean last recorded hemoglobin concentration was 116 g/L for the restrictive arm and 118 g/L for the liberal arm.

The investigators noted that there was a 13% absolute reduction in the proportion of patients transfused in the restrictive arm, a reduction in the amount of RBCs transfused between the arms, and a separation in hemoglobin concentration between the arms, but none of these differences were significant.

In addition, there was no significant difference in clinical outcomes between the arms, although the trial was not powered to assess these outcomes.

All-cause mortality at day 28 was 7% in the liberal transfusion arm and 5% in the restrictive arm. The rate of serious adverse events at day 28 was 22% and 18%, respectively.

At hospital discharge, further bleeding had occurred in 6% of patients in the liberal arm and 4% in the restrictive arm. At day 28, further bleeding had occurred in 9% and 5%, respectively.

At discharge, thromboembolic or ischemic events had occurred in 5% of patients in the liberal arm and 3% in the restrictive arm. At day 28, these events had occurred in 7% and 4%, respectively.

At discharge, acute transfusion reactions had occurred in 2% of patients in the liberal arm and 1% in the restrictive arm, and infections had occurred in 24% and 26%, respectively.

By discharge, 38% of patients in the liberal arm and 32% in the restrictive arm had required some therapeutic intervention. Surgical or radiological intervention was required in 3% and 4%, respectively.

Considering these results, the investigators said the TRIGGER trial has paved the way for a phase 3 trial that could provide evidence to inform transfusion guidelines for patients with AUGIB.

Blood for transfusion

Photo by Elise Amendola

A patient blood management (PBM) program can reduce transfusion use, cut costs, and improve outcomes in cardiac surgery patients, according to a single-center study.

A PBM program instituted at Eastern Maine Medical Center (EMMC) in Bangor substantially decreased the use of blood products, the loss of red blood cells, the length of hospital stays, the incidence of acute kidney injury, and direct costs.

Irwin Gross, MD, of EMMC, and his colleagues reported these results in Transfusion.

The team compared clinical and transfusion data from cardiac surgery patients treated at the center before the PBM program began (July 2006-March 2007) and after (April 2007-September 2012).

EMMC’s PBM initiative involved pre- and post-operative anemia management, a more restrictive transfusion threshold, the use of single-unit transfusions when necessary, and other measures.

The researchers analyzed data on 2662 patients, 387 treated before the PBM program began and 2275 treated after.

As expected, the rate of transfusions decreased after the PBM program began. The rate of red blood cell transfusion decreased from 39.3% to 20.8% (P<0.001), the rate of fresh-frozen plasma transfusion decreased from 18.3% to 6.5% (P<0.001), and the rate of platelet transfusion decreased from 17.8% to 9.8% (P<0.001).

Red blood cell loss decreased from a median of 721 mL to 552 mL (P<0.001), and pre-transfusion hemoglobin decreased from a mean of 7.2 ± 1.4 g/dL to 6.6 ± 1.2 g/dL (P<0.001).

Patients saw a decrease in the incidence of post-operative kidney injury from 7.6% to 5.0% (P=0.039) and a decrease in the median length of hospital stay from 10 days to 8 days (P<0.001).

Total adjusted direct costs decreased after the program began as well, falling from a median of $39,709 to $36,906 (P< 0.001).

There was no significant difference in the rate of hospital mortality or the incidence of cerebral vascular accident before and after the PBM program began.

Blood for transfusion

Photo by Elise Amendola

A patient blood management (PBM) program can reduce transfusion use, cut costs, and improve outcomes in cardiac surgery patients, according to a single-center study.

A PBM program instituted at Eastern Maine Medical Center (EMMC) in Bangor substantially decreased the use of blood products, the loss of red blood cells, the length of hospital stays, the incidence of acute kidney injury, and direct costs.

Irwin Gross, MD, of EMMC, and his colleagues reported these results in Transfusion.

The team compared clinical and transfusion data from cardiac surgery patients treated at the center before the PBM program began (July 2006-March 2007) and after (April 2007-September 2012).

EMMC’s PBM initiative involved pre- and post-operative anemia management, a more restrictive transfusion threshold, the use of single-unit transfusions when necessary, and other measures.

The researchers analyzed data on 2662 patients, 387 treated before the PBM program began and 2275 treated after.

As expected, the rate of transfusions decreased after the PBM program began. The rate of red blood cell transfusion decreased from 39.3% to 20.8% (P<0.001), the rate of fresh-frozen plasma transfusion decreased from 18.3% to 6.5% (P<0.001), and the rate of platelet transfusion decreased from 17.8% to 9.8% (P<0.001).

Red blood cell loss decreased from a median of 721 mL to 552 mL (P<0.001), and pre-transfusion hemoglobin decreased from a mean of 7.2 ± 1.4 g/dL to 6.6 ± 1.2 g/dL (P<0.001).

Patients saw a decrease in the incidence of post-operative kidney injury from 7.6% to 5.0% (P=0.039) and a decrease in the median length of hospital stay from 10 days to 8 days (P<0.001).

Total adjusted direct costs decreased after the program began as well, falling from a median of $39,709 to $36,906 (P< 0.001).

There was no significant difference in the rate of hospital mortality or the incidence of cerebral vascular accident before and after the PBM program began.

Blood for transfusion

Photo by Elise Amendola

A patient blood management (PBM) program can reduce transfusion use, cut costs, and improve outcomes in cardiac surgery patients, according to a single-center study.

A PBM program instituted at Eastern Maine Medical Center (EMMC) in Bangor substantially decreased the use of blood products, the loss of red blood cells, the length of hospital stays, the incidence of acute kidney injury, and direct costs.

Irwin Gross, MD, of EMMC, and his colleagues reported these results in Transfusion.

The team compared clinical and transfusion data from cardiac surgery patients treated at the center before the PBM program began (July 2006-March 2007) and after (April 2007-September 2012).

EMMC’s PBM initiative involved pre- and post-operative anemia management, a more restrictive transfusion threshold, the use of single-unit transfusions when necessary, and other measures.

The researchers analyzed data on 2662 patients, 387 treated before the PBM program began and 2275 treated after.

As expected, the rate of transfusions decreased after the PBM program began. The rate of red blood cell transfusion decreased from 39.3% to 20.8% (P<0.001), the rate of fresh-frozen plasma transfusion decreased from 18.3% to 6.5% (P<0.001), and the rate of platelet transfusion decreased from 17.8% to 9.8% (P<0.001).

Red blood cell loss decreased from a median of 721 mL to 552 mL (P<0.001), and pre-transfusion hemoglobin decreased from a mean of 7.2 ± 1.4 g/dL to 6.6 ± 1.2 g/dL (P<0.001).

Patients saw a decrease in the incidence of post-operative kidney injury from 7.6% to 5.0% (P=0.039) and a decrease in the median length of hospital stay from 10 days to 8 days (P<0.001).

Total adjusted direct costs decreased after the program began as well, falling from a median of $39,709 to $36,906 (P< 0.001).

There was no significant difference in the rate of hospital mortality or the incidence of cerebral vascular accident before and after the PBM program began.

Platelets for transfusion

The US Food and Drug Administration (FDA) has expanded the authorized use of Verax Biomedical’s Platelet PGD Test, which detects bacteria in platelets intended for transfusion.

The FDA previously approved the test for leukocyte-reduced apheresis platelets (in 2007) and platelets derived from whole blood (in 2009).

Now, the test has been approved for pre-storage pooled platelets and apheresis platelets in platelet additive solution C (PAS-C) and plasma.

This makes the Platelet PGD Test the only rapid test on the market that can check every commonly distributed platelet type in the US, according to Verax Biomedical.

About the test

The Platelet PGD Test is an immunoassay used on the day of transfusion at the point of care—a hospital or transfusion service—to detect bacterial contamination in platelets to be transfused.

The test consists of a disposable plastic cartridge and 3 pretreatment reagents. To use, the tester pretreats a freshly collected platelet sample (500µL) and applies it to the sample well on the test cartridge.

Lights on the cartridge change from yellow to blue-violet when the test is ready to be interpreted, which is typically about 20 minutes after the sample is applied to the cartridge. The lights confirm that the appropriate volume of a sample was added and the testing is complete.

If the test is positive, a pink line will appear in 1 of the 2 windows on the cartridge. One window represents Gram-positive bacteria and the other Gram-negative. Non-reactive samples will have no line in either window.

Now that the FDA has expanded the indications for the Platelet PGD Test, it can be used as a quality control test for pools of up to 6 units of leukocyte-reduced and non-leukocyte-reduced whole-blood-derived platelets suspended in plasma that are pooled within 4 hours of transfusion.

The test can also be used within 24 hours of transfusion as a safety measure following testing with a growth-based, quality control test cleared by the FDA. For this indication, the Platelet PGD Test can be used with:

• Leukocyte-reduced apheresis platelets suspended in plasma
• Leukocyte-reduced apheresis platelets suspended in PAS-C and plasma
• Pre-storage pools of up to 6 leukocyte-reduced whole-blood-derived platelets suspended in plasma.

In studies conducted by Verax Biomedical (described in the summary document here), the Platelet PGD Test successfully detected bacteria in pre-storage pools of whole-blood derived platelets suspended in plasma and leukocyte-reduced apheresis platelets suspended in plasma or PAS-C and plasma.

Platelets for transfusion

The US Food and Drug Administration (FDA) has expanded the authorized use of Verax Biomedical’s Platelet PGD Test, which detects bacteria in platelets intended for transfusion.

The FDA previously approved the test for leukocyte-reduced apheresis platelets (in 2007) and platelets derived from whole blood (in 2009).

Now, the test has been approved for pre-storage pooled platelets and apheresis platelets in platelet additive solution C (PAS-C) and plasma.

This makes the Platelet PGD Test the only rapid test on the market that can check every commonly distributed platelet type in the US, according to Verax Biomedical.

About the test

The Platelet PGD Test is an immunoassay used on the day of transfusion at the point of care—a hospital or transfusion service—to detect bacterial contamination in platelets to be transfused.

The test consists of a disposable plastic cartridge and 3 pretreatment reagents. To use, the tester pretreats a freshly collected platelet sample (500µL) and applies it to the sample well on the test cartridge.

Lights on the cartridge change from yellow to blue-violet when the test is ready to be interpreted, which is typically about 20 minutes after the sample is applied to the cartridge. The lights confirm that the appropriate volume of a sample was added and the testing is complete.

If the test is positive, a pink line will appear in 1 of the 2 windows on the cartridge. One window represents Gram-positive bacteria and the other Gram-negative. Non-reactive samples will have no line in either window.

Now that the FDA has expanded the indications for the Platelet PGD Test, it can be used as a quality control test for pools of up to 6 units of leukocyte-reduced and non-leukocyte-reduced whole-blood-derived platelets suspended in plasma that are pooled within 4 hours of transfusion.

The test can also be used within 24 hours of transfusion as a safety measure following testing with a growth-based, quality control test cleared by the FDA. For this indication, the Platelet PGD Test can be used with:

• Leukocyte-reduced apheresis platelets suspended in plasma
• Leukocyte-reduced apheresis platelets suspended in PAS-C and plasma
• Pre-storage pools of up to 6 leukocyte-reduced whole-blood-derived platelets suspended in plasma.

In studies conducted by Verax Biomedical (described in the summary document here), the Platelet PGD Test successfully detected bacteria in pre-storage pools of whole-blood derived platelets suspended in plasma and leukocyte-reduced apheresis platelets suspended in plasma or PAS-C and plasma.

Platelets for transfusion

The US Food and Drug Administration (FDA) has expanded the authorized use of Verax Biomedical’s Platelet PGD Test, which detects bacteria in platelets intended for transfusion.

The FDA previously approved the test for leukocyte-reduced apheresis platelets (in 2007) and platelets derived from whole blood (in 2009).

Now, the test has been approved for pre-storage pooled platelets and apheresis platelets in platelet additive solution C (PAS-C) and plasma.

This makes the Platelet PGD Test the only rapid test on the market that can check every commonly distributed platelet type in the US, according to Verax Biomedical.

About the test

The Platelet PGD Test is an immunoassay used on the day of transfusion at the point of care—a hospital or transfusion service—to detect bacterial contamination in platelets to be transfused.

The test consists of a disposable plastic cartridge and 3 pretreatment reagents. To use, the tester pretreats a freshly collected platelet sample (500µL) and applies it to the sample well on the test cartridge.

Lights on the cartridge change from yellow to blue-violet when the test is ready to be interpreted, which is typically about 20 minutes after the sample is applied to the cartridge. The lights confirm that the appropriate volume of a sample was added and the testing is complete.

If the test is positive, a pink line will appear in 1 of the 2 windows on the cartridge. One window represents Gram-positive bacteria and the other Gram-negative. Non-reactive samples will have no line in either window.

Now that the FDA has expanded the indications for the Platelet PGD Test, it can be used as a quality control test for pools of up to 6 units of leukocyte-reduced and non-leukocyte-reduced whole-blood-derived platelets suspended in plasma that are pooled within 4 hours of transfusion.

The test can also be used within 24 hours of transfusion as a safety measure following testing with a growth-based, quality control test cleared by the FDA. For this indication, the Platelet PGD Test can be used with:

• Leukocyte-reduced apheresis platelets suspended in plasma
• Leukocyte-reduced apheresis platelets suspended in PAS-C and plasma
• Pre-storage pools of up to 6 leukocyte-reduced whole-blood-derived platelets suspended in plasma.

In studies conducted by Verax Biomedical (described in the summary document here), the Platelet PGD Test successfully detected bacteria in pre-storage pools of whole-blood derived platelets suspended in plasma and leukocyte-reduced apheresis platelets suspended in plasma or PAS-C and plasma.

Blood for transfusion

Photo courtesy of UAB Hospital

A computerized system that analyzes vital signs can help healthcare professionals more accurately diagnose trauma patients with life-threatening bleeding, according to research published in Shock.

The system, known as APPRAISE, simultaneously analyzes blood pressure, heart rate, and breathing patterns during emergency transport.

And investigators found that APPRAISE accurately detected most cases of life-threatening bleeding.

“Providing faster care to patients who are bleeding to death saves lives,” said study author Andrew Reisner, MD, of Massachusetts General Hospital in Boston.

“While the clinical information that ambulance crews call in to trauma centers was sufficient to determine the presence of a life-threatening hemorrhage in about half the patients we studied, many other patients were in a ‘gray area’ and may or may not have been at risk of bleeding to death.”

“Our study demonstrated that automated analysis of patients’ vital signs during prehospital transport was significantly better at discriminating between patients who did and did not have life-threatening hemorrhage.”

The APPRAISE system incorporates software based on statistical techniques currently used in stock market trading and manufacturing to determine whether particular data points represent real problems and not random fluctuations.

The system uses an ultracompact personal computer to analyze data gathered by a standard patient monitor used in emergency transport vehicles.

For this study, the system was installed in 2 MedFlight helicopters and collected data on more than 200 trauma patients transported to participating Boston hospitals from February 2010 to December 2012. So that patients’ care was not affected by a still-unproven system, the APPRAISE system’s analysis was not provided to MedFlight crews.

The researchers also analyzed information from a 2005 study of vital sign data gathered manually by a Houston-based air ambulance system.

The team found the APPRAISE system could identify, with 76% sensitivity, patients who needed 9 or more units of packed red blood cells within 24 hours.

This was significantly more sensitive (P<0.05) than any prehospital Shock Index of 1.4 or higher (59%), initial systolic blood pressure less than 110 mmHg (50%), and any prehospital systolic blood pressure less than 90 mmHg (50%).

However, there was no signficant difference between the different measures with regard to specificity for identifying patients who did not need a blood transfusion within 24 hours.

Specificity was 87% for APPRAISE, 88% for any Shock Index of 1.4 or higher, 88% for initial systolic blood pressure less than 110 mmHg, and 90% for any prehospital systolic blood pressure less than 90 mmHg.

Notifications provided by APPRAISE would have been available within 10 minutes of initial monitoring and a median of 20 minutes before patients arrived at the trauma centers.

“The fact that decisions to proceed with surgery or to replenish lost blood often occur only after patients’ arrival means there are delays—sometimes brief but sometimes prolonged—in initiating such life-saving interventions,” Dr Reisner said.

“We are now working on a follow-up study to use this system in actual trauma care and will be measuring whether it truly leads to faster treatment of life-threatening hemorrhage and better patient outcomes. This approach could also be helpful for patients transported by ground ambulance and for hospitalized patients at risk of unexpected hemorrhage, such as during recovery from major surgery.”

Blood for transfusion

Photo courtesy of UAB Hospital

A computerized system that analyzes vital signs can help healthcare professionals more accurately diagnose trauma patients with life-threatening bleeding, according to research published in Shock.

The system, known as APPRAISE, simultaneously analyzes blood pressure, heart rate, and breathing patterns during emergency transport.

And investigators found that APPRAISE accurately detected most cases of life-threatening bleeding.

“Providing faster care to patients who are bleeding to death saves lives,” said study author Andrew Reisner, MD, of Massachusetts General Hospital in Boston.

“While the clinical information that ambulance crews call in to trauma centers was sufficient to determine the presence of a life-threatening hemorrhage in about half the patients we studied, many other patients were in a ‘gray area’ and may or may not have been at risk of bleeding to death.”

“Our study demonstrated that automated analysis of patients’ vital signs during prehospital transport was significantly better at discriminating between patients who did and did not have life-threatening hemorrhage.”

The APPRAISE system incorporates software based on statistical techniques currently used in stock market trading and manufacturing to determine whether particular data points represent real problems and not random fluctuations.

The system uses an ultracompact personal computer to analyze data gathered by a standard patient monitor used in emergency transport vehicles.

For this study, the system was installed in 2 MedFlight helicopters and collected data on more than 200 trauma patients transported to participating Boston hospitals from February 2010 to December 2012. So that patients’ care was not affected by a still-unproven system, the APPRAISE system’s analysis was not provided to MedFlight crews.

The researchers also analyzed information from a 2005 study of vital sign data gathered manually by a Houston-based air ambulance system.

The team found the APPRAISE system could identify, with 76% sensitivity, patients who needed 9 or more units of packed red blood cells within 24 hours.

This was significantly more sensitive (P<0.05) than any prehospital Shock Index of 1.4 or higher (59%), initial systolic blood pressure less than 110 mmHg (50%), and any prehospital systolic blood pressure less than 90 mmHg (50%).

However, there was no signficant difference between the different measures with regard to specificity for identifying patients who did not need a blood transfusion within 24 hours.

Specificity was 87% for APPRAISE, 88% for any Shock Index of 1.4 or higher, 88% for initial systolic blood pressure less than 110 mmHg, and 90% for any prehospital systolic blood pressure less than 90 mmHg.

Notifications provided by APPRAISE would have been available within 10 minutes of initial monitoring and a median of 20 minutes before patients arrived at the trauma centers.

“The fact that decisions to proceed with surgery or to replenish lost blood often occur only after patients’ arrival means there are delays—sometimes brief but sometimes prolonged—in initiating such life-saving interventions,” Dr Reisner said.

“We are now working on a follow-up study to use this system in actual trauma care and will be measuring whether it truly leads to faster treatment of life-threatening hemorrhage and better patient outcomes. This approach could also be helpful for patients transported by ground ambulance and for hospitalized patients at risk of unexpected hemorrhage, such as during recovery from major surgery.”

Blood for transfusion

Photo courtesy of UAB Hospital

A computerized system that analyzes vital signs can help healthcare professionals more accurately diagnose trauma patients with life-threatening bleeding, according to research published in Shock.

The system, known as APPRAISE, simultaneously analyzes blood pressure, heart rate, and breathing patterns during emergency transport.

And investigators found that APPRAISE accurately detected most cases of life-threatening bleeding.

“Providing faster care to patients who are bleeding to death saves lives,” said study author Andrew Reisner, MD, of Massachusetts General Hospital in Boston.

“While the clinical information that ambulance crews call in to trauma centers was sufficient to determine the presence of a life-threatening hemorrhage in about half the patients we studied, many other patients were in a ‘gray area’ and may or may not have been at risk of bleeding to death.”

“Our study demonstrated that automated analysis of patients’ vital signs during prehospital transport was significantly better at discriminating between patients who did and did not have life-threatening hemorrhage.”

The APPRAISE system incorporates software based on statistical techniques currently used in stock market trading and manufacturing to determine whether particular data points represent real problems and not random fluctuations.

The system uses an ultracompact personal computer to analyze data gathered by a standard patient monitor used in emergency transport vehicles.

For this study, the system was installed in 2 MedFlight helicopters and collected data on more than 200 trauma patients transported to participating Boston hospitals from February 2010 to December 2012. So that patients’ care was not affected by a still-unproven system, the APPRAISE system’s analysis was not provided to MedFlight crews.

The researchers also analyzed information from a 2005 study of vital sign data gathered manually by a Houston-based air ambulance system.

The team found the APPRAISE system could identify, with 76% sensitivity, patients who needed 9 or more units of packed red blood cells within 24 hours.

This was significantly more sensitive (P<0.05) than any prehospital Shock Index of 1.4 or higher (59%), initial systolic blood pressure less than 110 mmHg (50%), and any prehospital systolic blood pressure less than 90 mmHg (50%).

However, there was no signficant difference between the different measures with regard to specificity for identifying patients who did not need a blood transfusion within 24 hours.

Specificity was 87% for APPRAISE, 88% for any Shock Index of 1.4 or higher, 88% for initial systolic blood pressure less than 110 mmHg, and 90% for any prehospital systolic blood pressure less than 90 mmHg.

Notifications provided by APPRAISE would have been available within 10 minutes of initial monitoring and a median of 20 minutes before patients arrived at the trauma centers.

“The fact that decisions to proceed with surgery or to replenish lost blood often occur only after patients’ arrival means there are delays—sometimes brief but sometimes prolonged—in initiating such life-saving interventions,” Dr Reisner said.

“We are now working on a follow-up study to use this system in actual trauma care and will be measuring whether it truly leads to faster treatment of life-threatening hemorrhage and better patient outcomes. This approach could also be helpful for patients transported by ground ambulance and for hospitalized patients at risk of unexpected hemorrhage, such as during recovery from major surgery.”

Red blood cells

Image courtesy of NHLBI

The US Food and Drug Administration (FDA) has granted fast track designation to luspatercept for the treatment of patients with transfusion-dependent (TD) or non-transfusion-dependent (NTD) β-thalassemia.

Luspatercept is a modified activin receptor type IIB fusion protein that acts as a ligand trap for members of the transforming growth factor-β (TGF-β) superfamily involved in the late stages of erythropoiesis.

The drug regulates late-stage erythrocyte precursor differentiation and maturation. This mechanism of action is distinct from that of erythropoietin, which stimulates the proliferation of early stage erythrocyte precursor cells.

Luspatercept is currently in phase 2 trials in patients with β-thalassemia and individuals with myelodysplastic syndromes (MDS). Data from the trial in β-thalassemia were presented at the 2014 ASH Annual Meeting, and results from the MDS trial were recently presented at the 13th International Symposium on Myelodysplastic Syndromes.

Acceleron Pharma Inc. and Celgene Corporation are jointly developing luspatercept.

About fast track designation

The FDA’s fast track program is designed to facilitate the development of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

The designation provides pharmaceutical companies with the opportunity for more frequent interaction with the FDA while developing a drug. It also allows a sponsor to submit sections of a biologics license application on a rolling basis, as they are finalized.

“The FDA’s fast track designation for the luspatercept development program recognizes the serious unmet medical needs of patients with β-thalassemia and the potential for luspatercept in this area,” said Jacqualyn A. Fouse, president of hematology/oncology for Celgene.

“Celgene and Acceleron are working diligently to initiate a phase 3 clinical program in 2015 to treat patients with β-thalassemia, and we look forward to continuing to work closely with health authorities and other important stakeholders to advance this program.”

Phase 2 trial in β-thalassemia

At ASH 2014, researchers presented results of a phase 2 trial in which they investigated whether luspatercept could increase hemoglobin levels and decrease transfusion dependence.

The goal was to increase hemoglobin levels 1.5 g/dL or more for at least 2 weeks in NTD patients and decrease the transfusion burden by 20% or more over 12 weeks in TD patients.

Thirty patients, 7 TD and 23 NTD, received an injection of luspatercept every 3 weeks for 3 months at doses ranging from 0.2 mg/kg to 1.0 mg/kg.

Three-quarters of patients who received 0.8 mg/kg to 1.0 mg/kg of luspatercept experienced an increase in their hemoglobin levels or a reduction in their transfusion burden.

Of the NTD patients, 8 of 12 with iron overload at baseline experienced a reduction in liver iron concentration of 1 mg or more at 16 weeks.

TD patients had a more than 60% reduction in transfusion burden over 12 weeks. This included 2 patients with β0 β0 genotype, who experienced a 79% and 75% reduction.

Luspatercept did not cause any treatment-related serious or severe adverse events. The most common adverse events were bone pain (20%), headache (17%), myalgia (13%), and asthenia (10%).

There was 1 grade 3 dose-limiting toxicity of worsening lumbar spine bone pain. And 3 patients discontinued treatment early, 1 each with occipital headache, ankle pain, and back pain.

Red blood cells

Image courtesy of NHLBI

The US Food and Drug Administration (FDA) has granted fast track designation to luspatercept for the treatment of patients with transfusion-dependent (TD) or non-transfusion-dependent (NTD) β-thalassemia.

Luspatercept is a modified activin receptor type IIB fusion protein that acts as a ligand trap for members of the transforming growth factor-β (TGF-β) superfamily involved in the late stages of erythropoiesis.

The drug regulates late-stage erythrocyte precursor differentiation and maturation. This mechanism of action is distinct from that of erythropoietin, which stimulates the proliferation of early stage erythrocyte precursor cells.

Luspatercept is currently in phase 2 trials in patients with β-thalassemia and individuals with myelodysplastic syndromes (MDS). Data from the trial in β-thalassemia were presented at the 2014 ASH Annual Meeting, and results from the MDS trial were recently presented at the 13th International Symposium on Myelodysplastic Syndromes.

Acceleron Pharma Inc. and Celgene Corporation are jointly developing luspatercept.

About fast track designation

The FDA’s fast track program is designed to facilitate the development of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

The designation provides pharmaceutical companies with the opportunity for more frequent interaction with the FDA while developing a drug. It also allows a sponsor to submit sections of a biologics license application on a rolling basis, as they are finalized.

“The FDA’s fast track designation for the luspatercept development program recognizes the serious unmet medical needs of patients with β-thalassemia and the potential for luspatercept in this area,” said Jacqualyn A. Fouse, president of hematology/oncology for Celgene.

“Celgene and Acceleron are working diligently to initiate a phase 3 clinical program in 2015 to treat patients with β-thalassemia, and we look forward to continuing to work closely with health authorities and other important stakeholders to advance this program.”

Phase 2 trial in β-thalassemia

At ASH 2014, researchers presented results of a phase 2 trial in which they investigated whether luspatercept could increase hemoglobin levels and decrease transfusion dependence.

The goal was to increase hemoglobin levels 1.5 g/dL or more for at least 2 weeks in NTD patients and decrease the transfusion burden by 20% or more over 12 weeks in TD patients.

Thirty patients, 7 TD and 23 NTD, received an injection of luspatercept every 3 weeks for 3 months at doses ranging from 0.2 mg/kg to 1.0 mg/kg.

Three-quarters of patients who received 0.8 mg/kg to 1.0 mg/kg of luspatercept experienced an increase in their hemoglobin levels or a reduction in their transfusion burden.

Of the NTD patients, 8 of 12 with iron overload at baseline experienced a reduction in liver iron concentration of 1 mg or more at 16 weeks.

TD patients had a more than 60% reduction in transfusion burden over 12 weeks. This included 2 patients with β0 β0 genotype, who experienced a 79% and 75% reduction.

Luspatercept did not cause any treatment-related serious or severe adverse events. The most common adverse events were bone pain (20%), headache (17%), myalgia (13%), and asthenia (10%).

There was 1 grade 3 dose-limiting toxicity of worsening lumbar spine bone pain. And 3 patients discontinued treatment early, 1 each with occipital headache, ankle pain, and back pain.

Red blood cells

Image courtesy of NHLBI

The US Food and Drug Administration (FDA) has granted fast track designation to luspatercept for the treatment of patients with transfusion-dependent (TD) or non-transfusion-dependent (NTD) β-thalassemia.

Luspatercept is a modified activin receptor type IIB fusion protein that acts as a ligand trap for members of the transforming growth factor-β (TGF-β) superfamily involved in the late stages of erythropoiesis.

The drug regulates late-stage erythrocyte precursor differentiation and maturation. This mechanism of action is distinct from that of erythropoietin, which stimulates the proliferation of early stage erythrocyte precursor cells.

Luspatercept is currently in phase 2 trials in patients with β-thalassemia and individuals with myelodysplastic syndromes (MDS). Data from the trial in β-thalassemia were presented at the 2014 ASH Annual Meeting, and results from the MDS trial were recently presented at the 13th International Symposium on Myelodysplastic Syndromes.

Acceleron Pharma Inc. and Celgene Corporation are jointly developing luspatercept.

About fast track designation

The FDA’s fast track program is designed to facilitate the development of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

The designation provides pharmaceutical companies with the opportunity for more frequent interaction with the FDA while developing a drug. It also allows a sponsor to submit sections of a biologics license application on a rolling basis, as they are finalized.

“The FDA’s fast track designation for the luspatercept development program recognizes the serious unmet medical needs of patients with β-thalassemia and the potential for luspatercept in this area,” said Jacqualyn A. Fouse, president of hematology/oncology for Celgene.

“Celgene and Acceleron are working diligently to initiate a phase 3 clinical program in 2015 to treat patients with β-thalassemia, and we look forward to continuing to work closely with health authorities and other important stakeholders to advance this program.”

Phase 2 trial in β-thalassemia

At ASH 2014, researchers presented results of a phase 2 trial in which they investigated whether luspatercept could increase hemoglobin levels and decrease transfusion dependence.

The goal was to increase hemoglobin levels 1.5 g/dL or more for at least 2 weeks in NTD patients and decrease the transfusion burden by 20% or more over 12 weeks in TD patients.

Thirty patients, 7 TD and 23 NTD, received an injection of luspatercept every 3 weeks for 3 months at doses ranging from 0.2 mg/kg to 1.0 mg/kg.

Three-quarters of patients who received 0.8 mg/kg to 1.0 mg/kg of luspatercept experienced an increase in their hemoglobin levels or a reduction in their transfusion burden.

Of the NTD patients, 8 of 12 with iron overload at baseline experienced a reduction in liver iron concentration of 1 mg or more at 16 weeks.

TD patients had a more than 60% reduction in transfusion burden over 12 weeks. This included 2 patients with β0 β0 genotype, who experienced a 79% and 75% reduction.

Luspatercept did not cause any treatment-related serious or severe adverse events. The most common adverse events were bone pain (20%), headache (17%), myalgia (13%), and asthenia (10%).

There was 1 grade 3 dose-limiting toxicity of worsening lumbar spine bone pain. And 3 patients discontinued treatment early, 1 each with occipital headache, ankle pain, and back pain.

Blood donation

The US Food and Drug Administration (FDA) has released a draft guidance recommending changes to current policies aimed at reducing the risk of HIV transmission via blood products.

Among the recommended changes is a proposal to alter the policy that prevents men who have sex with men (MSM) from donating blood.

The FDA’s draft guidance is recommending that MSM be allowed to donate blood if they have abstained from sexual contact for 1 year.

If this draft guidance is implemented, the US would follow other countries that have lifted the lifetime ban on MSM blood donors in recent years, such as the UK, Canada, and South Africa.

Human rights groups—such as the Human Rights Campaign, the US’s largest lesbian, gay, bisexual, and transgender civil rights organization—have said the FDA’s proposed policy change is still discriminatory.

“While the new policy is a step in the right direction toward an ideal policy that reflects the best scientific research, it still falls far short of a fully acceptable solution because it continues to stigmatize gay and bisexual men,” said Human Rights Campaign Government Affairs Director David Stacy.

“This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply. It simply cannot be justified in light of current scientific research and updated blood screening technology.”

On the other side of the debate, blood banking groups—including the American Red Cross, America’s Blood Centers, and the American Association of Blood Banks—have voiced their support of a 1-year deferral period for MSM, as data have suggested this group has an increased risk of contracting HIV.

According to the Centers for Disease Control and Prevention, MSM are more severely affected by HIV than any other group 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 blood banking groups said in a joint statement.

“We believe the current FDA indefinite blood donation deferral for a man who has [had] 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.”

The FDA’s draft guidance seems to reflect that idea, as the 1-year deferral period does not only pertain to MSM. It also pertains to individuals who have a history of receiving a transfusion of whole blood or blood components, individuals with a history of syphilis or gonorrhea, and individuals who have had a tattoo or piercing in the last year, among others.

The draft guidance also includes recommendations pertaining to donor education material and donor history questionnaires, donor requalification, product retrieval and quarantine, testing requirements, and other issues.

The full guidance, available here, is open for comment.

Blood donation

The US Food and Drug Administration (FDA) has released a draft guidance recommending changes to current policies aimed at reducing the risk of HIV transmission via blood products.

Among the recommended changes is a proposal to alter the policy that prevents men who have sex with men (MSM) from donating blood.

The FDA’s draft guidance is recommending that MSM be allowed to donate blood if they have abstained from sexual contact for 1 year.

If this draft guidance is implemented, the US would follow other countries that have lifted the lifetime ban on MSM blood donors in recent years, such as the UK, Canada, and South Africa.

Human rights groups—such as the Human Rights Campaign, the US’s largest lesbian, gay, bisexual, and transgender civil rights organization—have said the FDA’s proposed policy change is still discriminatory.

“While the new policy is a step in the right direction toward an ideal policy that reflects the best scientific research, it still falls far short of a fully acceptable solution because it continues to stigmatize gay and bisexual men,” said Human Rights Campaign Government Affairs Director David Stacy.

“This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply. It simply cannot be justified in light of current scientific research and updated blood screening technology.”

On the other side of the debate, blood banking groups—including the American Red Cross, America’s Blood Centers, and the American Association of Blood Banks—have voiced their support of a 1-year deferral period for MSM, as data have suggested this group has an increased risk of contracting HIV.

According to the Centers for Disease Control and Prevention, MSM are more severely affected by HIV than any other group 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 blood banking groups said in a joint statement.

“We believe the current FDA indefinite blood donation deferral for a man who has [had] 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.”

The FDA’s draft guidance seems to reflect that idea, as the 1-year deferral period does not only pertain to MSM. It also pertains to individuals who have a history of receiving a transfusion of whole blood or blood components, individuals with a history of syphilis or gonorrhea, and individuals who have had a tattoo or piercing in the last year, among others.

The draft guidance also includes recommendations pertaining to donor education material and donor history questionnaires, donor requalification, product retrieval and quarantine, testing requirements, and other issues.

The full guidance, available here, is open for comment.

Blood donation

The US Food and Drug Administration (FDA) has released a draft guidance recommending changes to current policies aimed at reducing the risk of HIV transmission via blood products.

Among the recommended changes is a proposal to alter the policy that prevents men who have sex with men (MSM) from donating blood.

The FDA’s draft guidance is recommending that MSM be allowed to donate blood if they have abstained from sexual contact for 1 year.

If this draft guidance is implemented, the US would follow other countries that have lifted the lifetime ban on MSM blood donors in recent years, such as the UK, Canada, and South Africa.

Human rights groups—such as the Human Rights Campaign, the US’s largest lesbian, gay, bisexual, and transgender civil rights organization—have said the FDA’s proposed policy change is still discriminatory.

“While the new policy is a step in the right direction toward an ideal policy that reflects the best scientific research, it still falls far short of a fully acceptable solution because it continues to stigmatize gay and bisexual men,” said Human Rights Campaign Government Affairs Director David Stacy.

“This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply. It simply cannot be justified in light of current scientific research and updated blood screening technology.”

On the other side of the debate, blood banking groups—including the American Red Cross, America’s Blood Centers, and the American Association of Blood Banks—have voiced their support of a 1-year deferral period for MSM, as data have suggested this group has an increased risk of contracting HIV.

According to the Centers for Disease Control and Prevention, MSM are more severely affected by HIV than any other group 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 blood banking groups said in a joint statement.

“We believe the current FDA indefinite blood donation deferral for a man who has [had] 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.”

The FDA’s draft guidance seems to reflect that idea, as the 1-year deferral period does not only pertain to MSM. It also pertains to individuals who have a history of receiving a transfusion of whole blood or blood components, individuals with a history of syphilis or gonorrhea, and individuals who have had a tattoo or piercing in the last year, among others.

The draft guidance also includes recommendations pertaining to donor education material and donor history questionnaires, donor requalification, product retrieval and quarantine, testing requirements, and other issues.

The full guidance, available here, is open for comment.