Background: An effective pathogen inactivation (PI) technology for plasma must inactivate a broad range of pathogens with retention of haemostatic function suitable for therapeutic support. This study evaluated a broad panel of coagulation factors regarding functionality in plasma treated with the INTERCEPT Blood System (I-FFP).
Study design and methods: Apheresis plasma (600 ml) was treated with amotosalen and UVA. Aliquots of plasma were collected prior to and after photochemical treatment and frozen prior to analysis. Pro-coagulants, inhibitors and fibrinolytic proteins, contact pathway components, activation markers, the von Willebrand complex and complement proteins were analyzed.
Results: Retention of procoagulant factors in I-FFP ranged from 77 to 92% of pretreatment levels. Components of the von Willebrand complex, including multimers and von Willebrand cleavage protease activity (vWF:CP), remained within normal ranges after treatment. Endogenous inhibitors of coagulation were retained at 93 to 100% of baseline. Plasminogen and alpha-2 antiplasmin were retained at 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 thrombin-antithrombin complexes (TAT) in one of six replicates all markers of coagulation activation were well within normal ranges. Anaphylatoxins were not increased and C1-esterase inhibitor was fully retained.
Conclusion: Treatment of plasma with the INTERCEPT Blood System preserves proteins necessary for haemostasis without inappropriate activation of coagulation, fibrinolytic or complement pathways.