There are no critical reductions of the activities of clotting factors, inhibitors, and other important plasma proteins due to S/D treatment. Efficacy and safety of S/D plasma is not hampered by reduced activities of protein S and plasmin inhibitor. Dosage calculation and the evaluation of clinical response is simplified by usage of the more standardized S/D plasma compared to QFFP.
A reduction in the final citrate concentration of plasma collected by automated plasmapheresis results in higher yields of factors V, VIII, and IX without activation of hemostasis. More comprehensive studies should confirm previous work dealing with the establishment of the lowest citrate concentration acceptable in plasma used as therapeutic fresh-frozen plasma or as starting material for the manufacture of plasma derivatives.
Background and objectives: The aim of this study was to determine the potencies
of factor VII (FVII) and of activated FVII (FVIIa) in prothrombin complex
concentrates (PCC). Materials and methods: We examined 56 lots of
PCC from 5 manufacturers. Three brands were licensed preparations, and 1 product
scries had been involved in thromboembolic complications. FVII and FVIIa
were measured using a two-stage amidolytic assay and a specific clotting assay,
respectively. We also quantified FVII clotting activity by a one-stage assay reflecting
a mixture of FVII zymogen and FVIIa. Results: All PCC contained
substantial amounts of FVII, and FVIIa could be detected in all lots. There were
marked differences between manufacturers and some significant variabilities between
batches. The two lots involved in thromboembolic events contained considerably
more FVIIa than the PCC still licensed. The lowest FVIIa potencies
were observed in an experimental product series, indicating that PCC can be
produced without activation of FVII during the manufacturing process. Conclusion:
FVIIa is present in all PCC containing FVII. High FVIIa potencies may
contribute to the thrombogenic potential of these preparations, and determination
of FVIIa potencies should be included in the in vitro characterization of
PCC.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.