title: Photochemically treated fresh frozen plasma for transfusion of patients with acquired coagulopathy of liver disease.
abstract: An ex vivo photochemical treatment (PCT) process was developed to inactivate pathogens in fresh frozen plasma (PCT-FFP). A prospective, controlled, double-blinded, randomized study was conducted to evaluate the efficacy and safety of PCT-FFP compared with conventional FFP (C-FFP). Patients (n = 121) with acquired coagulopathy, largely due to liver disease, including hepatic transplantation, were transfused with either PCT-FFP or C-FFP for up to 7 days. Primary end points were changes in the prothrombin time (PT) and the partial thromboplastin time (PTT) in response to the first FFP transfusion. Secondary analyses compared changes in the PT and the PTT, factor VII levels, clinical hemostasis, blood component usage, and safety following FFP transfusions for up to 7 days. Following the first transfusion, correction in the PT and PTT adjusted for FFP dose and patient weight was not different. Changes in the PT were equivalent between treatment groups (P = .002 by noninferiority). Equivalence was not demonstrated for changes in the PTT. Following multiple transfusions, correction of the PT and the PTT was similar between groups. No differences were observed in use of blood components, clinical hemostasis, or safety. These results suggest PCT-FFP supported hemostasis in the treatment of acquired coagulopathy similarly to conventional FFP.
authors.affiliation: Department of Pathology, University of Virginia, Charlottesville, 22908-0286, USA. mintz@virginia.edu
authors.forename: Paul D
authors.initials: PD
authors.lastname: Mintz
authors.forename: Nathan M
authors.initials: NM
authors.lastname: Bass
authors.forename: Lawrence D
authors.initials: LD
authors.lastname: Petz
authors.forename: Randolph
authors.initials: R
authors.lastname: Steadman
authors.forename: Michael
authors.initials: M
authors.lastname: Streiff
authors.forename: Jeffery
authors.initials: J
authors.lastname: McCullough
authors.forename: Sandra
authors.initials: S
authors.lastname: Burks
authors.forename: David
authors.initials: D
authors.lastname: Wages
authors.forename: Sally
authors.initials: S
authors.lastname: Van Doren
authors.forename: Laurence
authors.initials: L
authors.lastname: Corash
mesh_terms: D000368:Aged; D001778:Blood Coagulation Disorders / Q000097:blood / Q000628:therapy*; D001803:Blood Transfusion; D004311:Double-Blind Method; D005167:Factor VII / Q000378:metabolism; D005260:Female; D006487:Hemostasis; D006801:Humans; D008107:Liver Diseases / Q000097:blood / Q000628:therapy*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D010314:Partial Thromboplastin Time; D017893:Photopheresis; D010949:Plasma; D011446:Prospective Studies; D011517:Prothrombin Time; D012449:Safety
chemical_list: D005167:Factor VII