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A regional haemovigilance retrospective study of four types of therapeutic plasma in a ten‐year survey period in France
Author(s) -
Bost V.,
OdentMalaure H.,
Chavarin P.,
Benamara H.,
Fabrigli P.,
Garraud O.
Publication year - 2013
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/vox.12007
Subject(s) - fresh frozen plasma , retrospective cohort study , medicine , surgery , platelet
Background and objectives Our objective was to compare the frequency of adverse events ( AE s) 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 AE s 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 solvent–detergent ( SD )]. Materials and Methods This is a retrospective study based on the national AE reporting database and on the regional database system for deliveries. AE s recorded after the delivery of 1 of the 4 types of FFP were pairwise compared, with appropriate statistical corrections. Results 105 964 FFP units were delivered (38·4% Q, 17·9% SD , 9·7% MB and 34% AI ). Statistical comparisons of AE s identified only a difference in AE rates between quarantine and solvent–detergent plasma. Conclusions FFP was confirmed to be extremely safe in general, especially if one considers ‘severe’ AE s. All types of FFP were associated with extremely low occurrences of AE s. Q, SD , MB and AI led, respectively, to 7·14, 4·86, 1·05 and 4·16 AE s per 10 000 deliveries.