Benefit of transfusion-related acute lung injury risk-minimization measures--German haemovigilance data (2006-2010).

Objective Based on the frequency of immune-mediated and non-immune-mediated transfusion-related acute lung injury (TRALI), the effect of risk-minimization measures was evaluated during a period of 5 years (20062010). Risk-minimization measures were implemented in 2008/2009, consisting of exclusion of female donors with a history of pregnancy or exclusion of female donors with human leucocyte antigen (HLA)/human neutrophil alloantigen (HNA) antibodies. Methods TRALI was confirmed according to the criteria of the International Haemovigilance Network. Based upon the results of donor testing of white-blood-cell antibodies (WBC-Ab) against HLA or HNAs, confirmed cases were classified as immune-or non-immune-mediated TRALI. Reporting rates were calculated on the basis of the annually transfused blood components, and pre-and post-implementation periods were compared. Results In total, 60 immune-mediated (75%) and 20 non-immune-mediated (25%) TRALI reactions were confirmed. A total of 68 (64 women and four men) donors were involved: seven red-blood-cell concentrates donors (13%), six platelet concentrate donors (10%), and 48 fresh frozen plasma (FFP) donors (77%). The reporting rate of immune-mediated TRALI caused by FFP decreased continuously; from 12 71 per million units in 2006 / 2007 to 6 81 per million units in 2008 / 2009 and no case in 2010. Conclusion The comparison of the pre-and the post-implementation period demonstrated a significantly reduced risk of TRALI events comparing 2006 / 2007 with 2010 (P-value: < 0 01). Furthermore, no case of TRALI-induced fatality occurred after the implementation of risk-minimization measures.