Epidemiology of Transfusion Related Acute Lung Injury in e-FIT, the French Hemovigilance Database: 1994 to 2006. A Study of the French Hemovigilance Network.

Background: Transfusion Related Acute Lung Injury (TRALI) is a life-threatening complication of allogenic blood transfusion, manifested typically by a non-cardiogenic pulmonary edema. However, the magnitude of the risk of TRALI remains unknown at this time, all the more so as a variety of other clinically similar respiratory complications can be associated with transfusion. Hemovigilance had been implemented in France since 1994. All adverse effects (AE) regardless of their severity should be notified on a normalized form to AFSSaPS, the French health products safety agency, as required by the French law.

Objective : to describe TRALI observed in e-FIT, the French hemovigilance database.

Population and methods: AE possibly, probably or definitely associated with transfusion were considered for inclusion. As the item “ TRALI” was explicitly present since 09/01/2001, we screened the database from 07/01/1994 to 09/01/2001 with “ pulmonary edema AND fluid overload excluded” , or with free comments including the words “TRALI ” , “ anti-granulocyte antibodies ”, “ non-cardiogenic pulmonary edema ” , “ white lung syndrome ” . The subsequent AE were considered for inclusion only if TRALI was the final diagnostic.

Results: From 07/01/1994 to 06/01/2006, 82,436 AE were registered in e-FIT, corresponding to about 30,000,000 labile blood products (LBP) transfused. 117 AE fulfilled the above criteria (3.9/1,000,000 LBP transfused). There were 59 men and 58 women, age = 0 to 86 (median 58); 34 men and 21 women were 60 years old or more. 107 patients presented with pulmonary symptoms, 93 with dyspnea, 63 with chills and/or hyperthermia and 53 with a typical pulmonary edema. 13 TRALI were fatal, 85 were life-threatening and 19 were benign. 42 patients received only packed red cells, 4 only fresh frozen plasma and 40 only platelet concentrates ; among the 31 remainders, 14 received platelets concentrates associated with an other LBP.

Conclusion:

1. Although the initial French database was not adapted to detect TRALI cases until 2001, the dynamics of notification is of interest ;

2. TRALI is more frequent in elderly patients, as noted in other reports ;

3. Platelets concentrates remains the more frequently LBP involved, but packed red cells also contribute to nearly half of the TRALI reported ;

4. Besides the classical life-threatening presentation, a benign form of TRALI seems to exist ;

5. A national working party is implementing new ways to define and investigate TRALI, which will provide more accurate information on TRALI in France.