Abstract
A multicenter, retrospective, observational study of 4-factor prothrombin complex concentrate (PCC) and/or fresh frozen plasma (FFP) use within routine clinical care unrelated to vitamin K antagonists was conducted. The PCC was administered preprocedure for correction of coagulopathy (prophylactic cohort) and treatment of bleeding postsurgery (treatment cohort). Of the 445 patients included, 40 were in the prophylactic cohort (PCC alone [n = 16], PCC and FFP [n = 5], FFP alone [n = 19]) and 405 were in the treatment cohort (PCC alone [n = 228], PCC and FFP [n = 123], FFP alone [n = 54]). Cardiovascular surgery was the most common setting. PCC doses ranged between 500 and 5000 IU. Effectiveness (assessed retrospectively) was reported as effective in 93.0% in the PCC-only group (95% confidence interval, 89.1% to 95.9%), 78.9% (70.8% to 85.6%) with PCC and FFP, and 86.3% (76.2% to 93.2%) with FFP alone. In the treatment cohort, international normalized ratio was significantly reduced in all 3 groups. In patients who received PCC, the rate of thromboembolic events (1.9%) was below rates in the literature for similar procedures. PCCs offer a potential alternative to FFP in the management of perioperative bleeding unrelated to oral anticoagulant therapy.
Highlights
Acquired coagulopathy is the most common indication for transfusing fresh frozen plasma (FFP).[1]
Studies have shown that increments in coagulation factor levels following standard doses of FFP do not reliably correct coagulopathy, whereas prothrombin complex concentrates (PCCs; 20-50 IU/kg) or higher doses of FFP (*30 mL/kg) can increase coagulation factor concentration to levels considered to be adequate for hemostasis.[4,5]
The waiver was provided because PCC was often a small component of patients’ overall treatment, and to ensure data validity, there was a need to include all potentially eligible patients.[22]
Summary
Acquired coagulopathy is the most common indication for transfusing fresh frozen plasma (FFP).[1]. PCCs are well established for emergency reversal of oral anticoagulation with vitamin K antagonists.[6] Beriplex P/N (CSL Behring, Marburg, Germany) is a 4-factor PCC containing coagulation factors II, VII, IX, and X along with proteins C, S, and Z. It is licensed in the United Kingdom and Europe for treatment and perioperative prophylaxis of bleeding related to acquired deficiencies in vitamin K-dependent coagulation factors, and for treatment and perioperative prophylaxis of bleeding in congenital deficiency of any of the vitamin K-dependent coagulation factors.[7] In other countries such as the United States, PCCs are not licensed for the treatment of acquired coagulopathy. The manufacturing process for coagulation factor concentrates includes purification and viral inactivation, minimizing potential risks such as pathogen transmission, and transfusionrelated acute lung injury.[9,10,11,12]
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