• Transfusion · Aug 2005

    Multicenter Study Clinical Trial

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

    • Pedro de Alarcon, Richard Benjamin, Marion Dugdale, Craig Kessler, Rinah Shopnick, Peter Smith, Thomas Abshire, Julie Hambleton, Prasad Matthew, Idith Ortiz, Alice Cohen, Barbara A Konkle, Michael Streiff, Martin Lee, David Wages, and Laurence Corash.
    • Department of Pediatric Hematology, University of Virginia, Charlottesville, Virginia, USA.
    • Transfusion. 2005 Aug 1; 45 (8): 1362-72.

    BackgroundPhotochemical 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 MethodsAn 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.ResultsThirty-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.ConclusionsReplacement coagulation factors in PCT-FFP exhibited kinetics and therapeutic efficacy consistent with conventional FFP.

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