Fresh frozen plasma prepared with amotosalen HCl (S‐59) photochemical pathogen inactivation: transfusion of patients with congenital coagulation factor deficiencies

Abstract

BACKGROUND: Photochemical treatment (PCT) with amotosalen HCl (S‐59) was developed to inactivate pathogens and white blood cells in plasma (PCT‐FFP) used for transfusion support. STUDY DESIGN AND METHODS: An open‐label, multicenter trial was conducted in patients with congenital coagulation factor deficiencies (factors [F]I, FII, FV, FVII, FX, FXI, and FXIII and protein C) to measure the kinetics of specific coagulation factors, hemostatic efficacy, and safety of PCT‐FFP. Posttransfusion prothrombin time (PT), partial thromboplastin time (PTT), and clinical hemostasis were evaluated before and after PCT‐FFP transfusions. RESULTS: Thirty‐four patients received 107 transfusions of PCT‐FFP for kinetic studies or therapeutic indications (mean dose, 12.8 ± 8.5 mL/kg). Incremental factor recoveries ranged from 0.9 to 2.4 IU per dL per IU per kg (FII, FV, FVII, FX, FXI, and protein C). Mean pretransfusion PT (20.7 ± 22.2 sec) corrected after PCT‐FFP (13.8 ± 2.4 sec, p < 0.001). Mean pretransfusion PTT (51.2 ± 29.3 sec) corrected after PCT‐FFP (32.0 ± 5.1 sec, p < 0.001). Thirteen patients required 77 transfusions for therapeutic indications. PCT‐FFP provided effective hemostasis and was well tolerated. CONCLUSIONS: Replacement coagulation factors in PCT‐FFP exhibited kinetics and therapeutic efficacy consistent with conventional FFP.