Frequency and severity of transfusion-related acute lung injury--German haemovigilance data (2006-2007).
OBJECTIVE
In an observational cohort study (2006-2007) the Paul-Ehrlich-Institut collected epidemiological data to investigate the frequency and causes of TRALI.


METHODS
Diagnosis of TRALI was confirmed according to criteria of the European Haemovigilance Network. Subsequent testing of white blood cell antibodies (WBC-Ab) against HLA or human neutrophil alloantigens was performed.


RESULTS
Of a total of 187 reported TRALI cases, 44 could be confirmed consisting of 35 cases of antibody-mediated TRALI and nine cases of non-immune-mediated TRALI. Eight of 44 affected patients (18%) had a fatal outcome, seven cases with WBC-Ab positive plasma donors and one case with red blood cell donors. WBC antibodies were found in one male and 39 female donors. In 34 female donors, a history of pregnancy was confirmed. WBC-Ab positive donors presented four HLA class I antibodies, 15 HLA class II antibodies, 13 HLA class I and class II antibodies, one HNA-2a, and seven HNA-3a antibodies. WBC antibodies matching with recipient antigens were found exclusively in 28 female donors; 26 FFP donors, one platelet donor and one red blood cell donor. Reporting frequency of immune-mediated TRALI was 1:66,000 for fresh frozen plasma, 1:2.86 million for red blood cell concentrates and 1:420,000 for platelet concentrates. Reporting frequency of TRALI-related fatalities was 1:285,000 for FFP.


CONCLUSIONS
Haemovigilance data show the significance of female donors with a history of pregnancy for the development of antibody-mediated TRALI. Manufacturing of FFP from male plasma and female donor screening for WBC-Ab could represent preventive measures.
Keller-Stanislawski
B
B
Department of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institute, Langen, Germany.
Reil
A
A
Günay
S
S
Funk
M B
MB
D055371:Acute Lung Injury / Q000453:epidemiology* / Q000209:etiology / Q000276:immunology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001787:Blood Group Incompatibility / Q000276:immunology*; D005260:Female; D005858:Germany; D006680:HLA Antigens / Q000276:immunology; D006801:Humans; D015994:Incidence; D007518:Isoantibodies / Q000276:immunology*; D007519:Isoantigens / Q000276:immunology; D007962:Leukocytes / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009504:Neutrophils / Q000276:immunology; D015996:Survival Rate; D065227:Transfusion Reaction; D055815:Young Adult
D006680:HLA Antigens; D007518:Isoantibodies; D007519:Isoantigens