INTERCEPT plasma: comparability with conventional fresh-frozen plasma based on coagulation function--an in vitro analysis.
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).


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.


CONCLUSIONS
Treatment of plasma with the INTERCEPT Blood System preserves proteins necessary for haemostasis without inappropriate activation of coagulation, fibrinolytic or complement pathways.
Irsch
J
J
Cerus B.V., Amersfoort, The Netherlands. jirsch@cerus.com
Pinkoski
L
L
Corash
L
L
Lin
L
L
D001777:Blood Coagulation; D001779:Blood Coagulation Factors / Q000187:drug effects / Q000528:radiation effects; D011564:Furocoumarins / Q000009:adverse effects; D006487:Hemostasis; D006801:Humans; D010949:Plasma / Q000187:drug effects* / Q000528:radiation effects*; D013242:Sterilization / Q000592:standards*; D014466:Ultraviolet Rays / Q000009:adverse effects*; D038301:Virus Inactivation
D001779:Blood Coagulation Factors; D011564:Furocoumarins; C118577:amotosalen