title: Benefit of transfusion-related acute lung injury risk-minimization measures--German haemovigilance data (2006-2010).
abstract: 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 (2006-2010). 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut Langen, Langen, Germany. Markus.Funk@pei.de
authors.forename: M B
authors.initials: MB
authors.lastname: Funk
authors.forename: S
authors.initials: S
authors.lastname: Guenay
authors.forename: A
authors.initials: A
authors.lastname: Lohmann
authors.forename: O
authors.initials: O
authors.lastname: Henseler
authors.forename: M
authors.initials: M
authors.lastname: Heiden
authors.forename: K M O
authors.initials: KM
authors.lastname: Hanschmann
authors.forename: B
authors.initials: B
authors.lastname: Keller-Stanislawski
mesh_terms: D055371:Acute Lung Injury / Q000517:prevention & control*; D001323:Autoantibodies / Q000097:blood; D001782:Blood Donors; D058731:Blood Safety / Q000706:statistics & numerical data*; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D011247:Pregnancy; D012306:Risk; D065227:Transfusion Reaction
chemical_list: D001323:Autoantibodies