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Blood, 1 May 2006, Vol. 107, No. 9, pp. 3753-3760.
Prepublished online as a Blood First Edition Paper on January 12, 2006; DOI 10.1182/blood-2004-03-0930.
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Submitted March 11, 2004
Accepted December 6, 2005
Photochemically treated fresh frozen plasma for transfusion of patients with acquired coagulopathy of liver disease
Paul D Mintz*, Nathan M Bass, Lawrence D Petz, Randolph Steadman, Michael Streiff, Jeffery McCullough, Sandra Burks, David Wages, Sally Van Doren, and Laurence Corash
Department of Pathology and Internal Medicine, University of Virginia, Charlottesville, VA, USA
Department of Medicine, University of California, San Francisco, CA, USA
Department of Pathology and Laboratory Medicine, and Department of Anesthesiology, University of California, Los Angeles, CA, USA
Department of Medicine, Johns Hospkins University, Baltimore, MD, USA
Departments of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN, USA
Department of Surgery, University of Virginia, Charlottesville, VA, USA
Cerus Corporation, Concord, CA, USA
* Corresponding author; email: mintz{at}virginia.edu.
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 transplant, were transfused with either PCT-FFP or C-FFP for up to 7 days. Primary endpoints 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, were not different. Changes in the PT were equivalent between treatment groups (p=0.002, by non-inferiority). Equivalence was not demonstrated for changes in the PTT. Following multiple transfusions, correction of the PT and the PTT were 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 similar to conventional FFP.

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