One change will extend from eight to 24 hours the potential elapsed time between blood draws and freezing of plasma. The second change is a recommendation that doctors ordering directed donor products should use blood centers, such as Stanford, which offer a test for antibodies to the parasite Trypanosoma cruzi, the causative agent of Chagas’ disease.
The changes, reported to the SHC Critical Care Committee in March, were outlined by Magali Fontaine, associate director of the transfusion service and assistant professor of pathology.
Stanford Blood Center (SBC) medical directors, Dorothy Nguyen and Susan Galel, are extending the window for freezing plasma, effective in May, to ensure adequate supplies of plasma. The change was made after an extensive safety and efficacy review in light of a potential reduction in eligible donors. Women with a history of pregnancy as well as persons who themselves have been transfused in the past are no longer eligible to donate transfusable plasma. This nationwide restriction on donors is expected to reduce the risk of Transfusion Related Acute Lung Injury or TRALI - now the most common cause of transfusion-related fatalities in the U.S. The majority of TRALI fatalities have been found to be associated with plasma-containing blood products from donors alloimmunized to HLA or neutrophil antigens. Most often, these are donors with a history of pregnancy.
According to Nguyen, Plasma frozen within 24 hours is approved by the FDA and AABB and is a comparable alternative to plasma frozen within 6 to 8 hours (fresh frozen plasma or FFP). Plasma frozen within 24 hours is now used interchangeably with FFP in most transfusion facilities. In North America, production of plasma frozen within 24 hours is largely replacing the production of FFP.
Nguyen said that with the addition of the T. cruzi testing, effective March 5, two business days will be required to complete testing for any blood donation, “but the addition of T. cruzi testing should not affect the release of products by the Transfusion Service,” Fontaine said.
“Although this is not an FDA required test, SBC will test all blood products donated at our facility. Since not all blood centers will test for T. cruzi, SBC plans to import allogeneic products from blood centers that [do] perform Chagas testing,” Nguyen said.
“The SBC recommends that doctors ordering directed donor products choose blood centers that perform T. cruzi testing. All directed donor products will be forwarded on to the hospital, regardless of donor testing status. If you want to know if a directed donation has been tested for T. cruzi, you can contact the collecting facility,” she said.
