title: Stability of solvent/detergent-treated plasma and single-donor fresh-frozen plasma during 48 h after thawing.
abstract: The aim of this study was to compare the quality of solvent/detergent (SD) treated plasma, Octaplas, and single-donor fresh-frozen plasma (FFP) units during 48-h storage after thawing. Octaplas bags of different blood groups and individual FFP units were thawed and stored at either +4 degrees C or at room temperature (RT) for 48 h. Samples drawn during the observation period were investigated on various coagulation factor and protease inhibitor activities using standard coagulation and chromogenic assays. The generation of FVIIa was followed as a marker of coagulation factor activation. All investigated coagulation factors and protease inhibitors were stable for at least 8h during storage of Octaplas at +4 degrees C. FVIII levels started to decline earlier in FFP than in Octaplas at both storage temperatures. Stored Octaplas OD660 values were more stable during the storage period than FFP OD660 values, whereas VWF multimeric patterns were comparably stable in both types of plasma. In conclusion, this stability study has demonstrated that thawed Octaplas maintains its high quality, even with a time safety margin, for 8 h at +4 degrees C and for 6 h at RT. In general, there was more variability in coagulation factor levels among different FFP units compared with different Octaplas batches.
authors.affiliation: Octapharma Pharmazeutika Produktionsges.m.b.H., Pre-Clinical Research and Development, Oberlaaer Strasse 235, A-1100 Vienna, Austria. andrea.heger@octapharma.at
authors.forename: Andrea
authors.initials: A
authors.lastname: Heger
authors.forename: Jürgen
authors.initials: J
authors.lastname: Römisch
authors.forename: Tor-Einar
authors.initials: TE
authors.lastname: Svae
mesh_terms: D001780:Blood Coagulation Tests; D015925:Cryopreservation; D003902:Detergents / Q000737:chemistry; D015944:Factor VIIIa / Q000032:analysis*; D006801:Humans; D010949:Plasma / Q000737:chemistry*; D012997:Solvents / Q000737:chemistry; D013997:Time Factors; D014841:von Willebrand Factor / Q000032:analysis*
chemical_list: D003902:Detergents; D012997:Solvents; D014841:von Willebrand Factor; D015944:Factor VIIIa