The aim of this pilot study was to assess the feasibility of a toleran
ce study of qualified (secured by quarantine or solvent-detergent-trea
ted) fresh frozen plasma (FFP) in real conditions of use. We included
all patients receiving qualified FFP during a one-month observation pe
riod in three french hospitals (Besancon, Brest, Lyon). The 192 FFP tr
ansfusion episodes corresponded to 111 patients. Only two thirds of al
l prescriptions corresponded to indications mentioned in the ministeri
al order of december 1991. Forty-two episodes consisted of FFP only; i
n the 150 remaining episodes, at least one product (mostly labile bloo
d products) had been injected within 24 hours before or after the plas
ma injection. The free interval between FFP transfusion and the neares
t associated product was usually less than three hours. Only one side
effect was notified. This pilot study points out the difficulties of a
tolerance study of qualified FFP in real conditions of use. It also r
aises the necessity to clarify current indications of FFP.