Studies, Survey Reveal Lessons Learned, Actions Taken to Reduce the Risk of TRALI
Efforts to reduce the risks associated with transfusion-related acute lung injury have been successful, according to Steve Kleinman, MD, who reported on TRALI strategies over a six-year period and reviewed results of the AABB TRALI survey during the 2009 Annual Meeting and TXPO.
“We now have substantial data from multiple sources that show risk reduction measures for plasma, meaning that going to predominantly male plasma has definitely been effective for reducing the risk of TRALI,” said Kleinman, who is a clinical professor of pathology at the University of British Columbia as well as medical advisor to AABB.
By using data from the United Kingdom’s Serious Hazards of Transfusion System, or SHOT; the Food and Drug Administration; and the American Red Cross, along with a retrospective hospital study in the U.K., Kleinman showed that a positive difference has been made.
According to the data, in 2008 SHOT report the number of TRALI-related fatalities using any type of blood component decreased from 2003. By moving to predominantly male plasma, the number of TRALI cases from plasma transfusion decreased as well. Data from FDA showed a decrease in TRALI-related fatalities related to plasma transfusion from 22 cases in fiscal year 2006 to four cases in fiscal year 2008. ARC data also showed that by 2008, there were no fatalities, compared to five fatalities in 2007 and six deaths in 2006.
Kleinman found that solvent detergent-treated plasma also had high efficacy based on a report from the French hemovigilance system. According to the report, out of 460,000 SD units, there were no TRALI cases reported compared to 650,000 units of FFP, where 14 cases of TRALI were reported.
Although data are growing for establishing the efficacy of TRALI risk reduction strategies for plasma, there isn’t much information on the risk from platelets.
“Risk-reduction measures for platelets are thus far limited, and there are no data to evaluate what has been done,” Kleinman said. “In fact, there are only sparse data for comparing the risk of data from different platelet sources.”
Based on the limited data, he concluded that “whether you get apheresis platelets or a pool of whole blood-derived platelets, you would probably get the same TRALI risk, but we really don’t know what that risk is.”
These reports show positive results based on facilities implementing recommendations to reduce the risks of TRALI, according to an AABB TRALI survey administered in August. Kleinman reported on the current results of the survey during the session but added that there is more data that needs to be analyzed.
Survey results focused on 47 U.S. blood centers that responded, which represent the majority of platelets transfused in the U.S. Based on the results, 41 centers have implemented measures to reduce the risk of TRALI from platelets, while two centers have plans to implement something by the end of the year. Four said they have no plans to implement any measures.
Of those that have implemented some measure, 33 indicated that part of their strategy was to reduce risk is to increase the number of apheresis platelets from male donors, while eight decided to increase the amount of whole blood-derived platelets manufactured.
There are 21 centers currently testing or making progress toward HLA antibody testing of platelet apheresis donors. Eight facilities have future plans to do HLA antibody testing, while 18 do not have a plan to do so.
The survey also questioned hospitals about risk-reduction practices for platelets. There were 49 respondents, and of that number 28 had completed measures for platelet risk reduction and three were in the process of implementation.
Of those that have implemented some risk reduction, 19 currently perform HLA antibody testing of platelet apheresis, while seven have future plans of implementing testing. Twenty-two hospitals haven’t considered creating a plan.
“Virtually all centers have implemented policies for reducing TRALI risk from plasma and the majority from platelet transfusion, although there is variation between centers,” Kleinman said. “The results of the survey are positive and show that we are moving in the right direction to help keep the blood supply safe and our patients safer.”
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