Because of the data associating HLA antibodies with TRALI and the incidence of HLA antibodies in multiparous patients, the AABB (Association Bulletin #06-07) encouraged a voluntary mitigation strategy, which recommended a reduction or elimination of the production of FFP from all females or patients with a history of pregnancy. An alternative approach, especially for products in short supply, like group AB plasma, was to test patients with a pregnancy history for HLA antibodies and limit production to those who tested negative. Several published studies have reported that these mitigation strategies have been successful in significantly reducing the number of cases of TRALI and the number of TRALI fatalities. In 2010, the FDA noted that TRALI fatalities had decreased 89% from the peak (before mitigation efforts) of 35 cases in 2006 to 4 cases in 2010. The trend continued with only four reported cases in both 2011 and 2012.
The AABB Blood Bank and Transfusion Service Program Unit has developed a standard that addresses TRALI mitigation, which is in effect to the present day. The standard reads:
"Plasma and whole blood for allogeneic transfusion shall be from males, donors who have not been pregnant, or individuals who have been tested since their most recent pregnancy and found to be negative for HLA antibodies."
Components addressed by this standard include:
- Fresh Frozen Plasma (FFP) prepared from whole blood
- FFP collected by apheresis
- Plasma, Cryoprecipitate-Reduced
- Plasma, Frozen Within 24 Hours of Phlebotomy (PF24)
- Thawed plasma from any of the products listed above
- Liquid Plasma
- Whole Blood (if designated for transfusion as Whole Blood)
Note: Packed RBCs are not included in this standard.
