Prothrombin complex concentrate in surgical patients: retrospective evaluation of vitamin K antagonist reversal and treatment of severe bleeding.
Crit Care. 2009 Nov 30;13(6):R191
Authors: Schick KS, Fertmann JM, Jauch KW, Hoffmann JN
ABSTRACT: INTRODUCTION: Prothrombin complex concentrates (PCCs) are recommended for rapid reversal of vitamin K anticoagulants. As they normalize levels of vitamin K dependent clotting factors and re-establish hemostasis, they may also be used as adjunctive therapy in patients with major bleeding. The aim of this study was to retrospectively evaluate the efficacy of PCCs in the surgical setting. METHODS: The case notes of 50 patients requiring urgent oral anticoagulation reversal (n = 12) or with severe perioperative coagulopathic bleeding (n = 38) who received an infusion of PCC (Beriplex P/N(R) 500) at the surgical department of the University of Munich Hospital, Germany were retrospectively reviewed. Efficacy of PCC application was evaluated using the Quick test, reported as an international normalized ratio (INR), hemodynamic measurements and requirement for blood products. Safety assessments included whole blood hemoglobin levels and specific parameters of organ dysfunction. RESULTS: Baseline characteristics were comparable, except that mean baseline INR and hemoglobin levels were significantly higher (P < 0.01) in anticoagulation reversal than in bleeding patients. In anticoagulation reversal, the INR was significantly reduced (from 2.8 +/- 0.2 at baseline to 1.5 +/- 0.1, P < 0.001) after one PCC infusion (median dose 1500 IU; lower quartile 1000, upper quartile 2000). No major bleeding was observed during surgery after PCC administration. Only one patient received platelets and red blood cell transfusion after PCC administration. In bleeding patients, infusion of PCC (median dose 2000 IU; lower quartile 2000, upper quartile 3000) significantly reduced the INR from 1.7 +/- 0.1 at baseline to 1.4 +/- 0.1 (P < 0.001). This decrease was unrelated to fresh frozen plasma or vitamin K administration. Bleeding stopped after PCC administration in 4/11 (36%) patients with surgical bleeding and 26/27 (96%) patients with diffuse bleeding. Hemoglobin levels increased significantly from baseline in bleeding patients (P < 0.05) and mean arterial pressure stabilized (P < 0.05). No thrombotic events or changes in organ function were reported in any patient. CONCLUSIONS: PCC application effectively reduced INRs in anticoagulation reversal, allowing surgical procedures and interventions without major bleeding. In bleeding patients, the improvement in coagulation after PCC administration was judged to be clinically significant.
PMID: 19948037 [PubMed - as supplied by publisher]