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TRALI Risk Mitigation Recommendations Approved by AABB

By Jessica Pellegrini, ASBP Staff Writer
The AABB approves a new TRALI risk mitigation standard to be implemented April 1, 2014.
The AABB approves a new TRALI risk mitigation standard to be implemented April 1, 2014.
The AABB has approved a new TRALI risk mitigation standard to be implemented April 1. According to AABB Bulletin 14-02, all plasma and whole blood collected and prepared for allogeneic transfusion after April 1, must be either from males, or females who have never been pregnant or who have had a negative HLA antibodies test since their most recent pregnancy.

According to the Food and Drug Administration, TRALI, or transfusion-related acute lung injury, is a “serious pulmonary syndrome that can lead to death if not recognized and treated appropriately.” It is most often associated with transfusion of plasma from female donors who have been pregnant one or more times and subsequently found to be positive for anti-HLA antibodies. HLA, the human leukocyte antigen, helps the immune system distinguish the body’s own proteins from proteins made by foreign invaders such as bacteria.

“Numerous studies have documented that a TRALI risk mitigation strategy using some or all of the interventions specified (in the new standard) will substantially reduce TRALI incidence from allogeneic plasma transfusion,” the AABB bulletin said.

The AABB lists two options facilities may use to meet the new standard. Facilities can either collect from males and never previously pregnant females or implement targeted HLA antibody testing on females that have indicated a previous history of pregnancy. If a facility does not obtain a pregnancy history, it must perform HLA antibody testing on all female donors of apheresis plasma and whole blood “used to produce transfusable plasma components” and whole blood designated for transfusion as whole blood. For facilities that do not chose to implement targeted HLA antibody testing, “a pregnancy history must be obtained for any female whose donated plasma will be made available for transfusion.”

“The Armed Services Blood Program Office and the ASBP are working together to implement policy to minimize any impact the new standard will have on the military blood program,” Navy Lt. Cmdr. Leslie Riggs, ASBP deputy director of policy, said. “While the new measures may increase production costs to our blood centers that implement HLA testing, that cost will certainly be offset by the increased safety of the product and well-being of our blood recipients."

Further information on the TRALI risk mitigation standard can be found on the AABB website here. (An AABB membership is required to access the bulletin.)

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