Abstracts

Introduction: INTERCEPT Plasma (I-FFP) is prepared using amotosalen and UVA light to inactivate pathogens (PI) and leukocytes. Phase 3 clinical trials, using a prototype processing set, demonstrated I-FFP supported hemostasis for treatment of coagulopathies and TTP. The processing set has been modified to improve productivity while maintaining PI efficacy.

Objective: The objective of this study was to characterize I-FFP prepared using the improved processing set.

Methods: Using standardized clinical assays, a broad spectrum of coagulation and activation proteins were measured in 600 mL units of fresh apheresis plasma (n=6) before and after PI. Analyses included factors I through XIII, vWf, proteins C and S, antithrombin, alpha-1 antitrypsin, plasminogen, alpha-2 antiplasmin, HMWK, PK, FXIIa, FVIIa, F1.2, TAT, d-dimers, C3a, C5a, and C1-esterase inhibitor.

Results: Retention of procoagulant factors in I-FFP ranged from 77% to 92% of baseline. Components of the von Willebrand complex, including multimers and vWf:CP activity, remained within normal ranges after PI treatment. Endogenous inhibitors of coagulation were retained 93% to 100%. Plasminogen and alpha 2-antiplasmin were retained 94% and 78%, respectively. Retention of contact factors was variable as some factors were below the reference range prior to PI treatment. With the exception of TAT in one of six units, all markers of coagulation activation were well within normal ranges. Anaphylatoxins were not increased. Conclusion: Extensive in vitro analyses of coagulation and activation proteins demonstrates that INTERCEPT Plasma is functionally similar to untreated plasma.