A regional haemovigilance retrospective study of four types of therapeutic plasma in a ten-year survey period in France

Background and objectives Our objective was to compare the frequency of adverse events (AEs) due to any of the 4 types of fresh-frozen plasma (FFP) prepared and delivered by the French Blood Establishment (EFS) over a 10-year period. Surveillance of AEs and vigilance was performed according to a homogeneous policy. The four types of FFP comprised of one type (methylene blue [MB) that was stopped since then and of another type [amotosalen (AI)] that was recently introduced, along with two conventional products [quarantine (Q) and solventdetergent (SD)]. Materials and Methods This is a retrospective study based on the national AE reporting database and on the regional database system for deliveries. AEs recorded after the delivery of 1 of the 4 types of FFP were pairwise compared, with appropriate statistical corrections. Results 105964 FFP units were delivered (38 center dot 4% Q, 17 center dot 9% SD, 9 center dot 7% MB and 34% AI). Statistical comparisons of AEs identified only a difference in AE rates between quarantine and solventdetergent plasma. Conclusions FFP was confirmed to be extremely safe in general, especially if one considers severe' AEs. All types of FFP were associated with extremely low occurrences of AEs. Q, SD, MB and AI led, respectively, to 7 center dot 14, 4 center dot 86, 1 center dot 05 and 4 center dot 16 AEs per 10000 deliveries.