Photochemically treated fresh frozen plasma for transfusion of patients with acquired coagulopathy of liver disease

• Published in: Blood Vol. 107; no. 9; pp. 3753 - 3760
• Main Authors: Mintz, Paul D., Bass, Nathan M., Petz, Lawrence D., Steadman, Randolph, Streiff, Michael, McCullough, Jeffery, Burks, Sandra, Wages, David, Van Doren, Sally, Corash, Laurence
• Format: Journal Article
• Language: English
• Published: Washington, DC Elsevier Inc 01-05-2006; The Americain Society of Hematology
• Subjects: Aged; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Blood Coagulation Disorders - blood; Blood Coagulation Disorders - therapy; Blood Transfusion; Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis; Double-Blind Method; Factor VII - metabolism; Female; Hematologic and hematopoietic diseases; Hemostasis; Humans; Liver Diseases - blood; Liver Diseases - therapy; Liver Transplantation; Male; Medical sciences; Middle Aged; Partial Thromboplastin Time; Photopheresis; Plasma; Platelet diseases and coagulopathies; Prospective Studies; Prothrombin Time; Safety; Transfusions. Complications. Transfusion reactions. Cell and gene therapy; Human; Amotosalen; Transfusion; Acquired; Photochemical method; Hepatic disease; Hemopathy; Inactivation; Blood plasma; Infection; Prevention; Treatment; Pathogenic; Digestive diseases; Transmission from man to man; Coagulation factor; Coagulopathy
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2004-03-0930

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.