TY - JOUR
T1 - Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation
T2 - Transfusion of patients with congenital coagulation factor deficiencies
AU - De Alarcon, Pedro
AU - Benjamin, Richard
AU - Dugdale, Marion
AU - Kessler, Craig
AU - Shopnick, Rinah
AU - Smith, Peter
AU - Abshire, Thomas
AU - Hambleton, Julie
AU - Matthew, Prasad
AU - Ortiz, Idith
AU - Cohen, Alice
AU - Konkle, Barbara A.
AU - Streiff, Michael
AU - Lee, Martin
AU - Wages, David
AU - Corash, Laurence
PY - 2005/8
Y1 - 2005/8
N2 - BACKGROUND: Photochemical treatment (PCT) with amotosalen HCI (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-FFR 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 FFR.
AB - BACKGROUND: Photochemical treatment (PCT) with amotosalen HCI (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-FFR 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 FFR.
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U2 - 10.1111/j.1537-2995.2005.00216.x
DO - 10.1111/j.1537-2995.2005.00216.x
M3 - Article
C2 - 16078927
AN - SCOPUS:23844453081
SN - 0041-1132
VL - 45
SP - 1362
EP - 1372
JO - Transfusion
JF - Transfusion
IS - 8
ER -