Reversal of Coagulopathy Using Prothrombin Complex Concentrates is Associated with Improved Outcome Compared to Fresh Frozen Plasma in Warfarin-Associated Intracranial Hemorrhage

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There are no studies demonstrating that prothrombin complex concentrates (PCC) improves outcome compared FFP in patients with warfarin-associated intracranial hemorrhage. A prospective, observational study was conducted of patients who received PCC (Bebulin VH), FFP, or PCC+FFP. All groups received vitamin K 10mg IV. INR reversal (<1.4), adverse events (venous thromboembolism, myocardial infraction, pulmonary edema), major hemorrhage (new or worsened intracranial hemorrhage, anemia requiring transfusion or GI bleed), and 3-month functional outcome were compared between the groups using Chi squared and logistic regression analysis. Of 64 patients, PCC alone was used in 16 (mean dose 48IU/kg), FFP alone in 25 (mean dose 12.5ml/kg), and PCC+FFP in 23 (median doses 47.4IU/kg and 11.4ml/kg, respectively). INR correction occurred in 88, 84, and 70%, respectively. There were no differences in time to INR correction or adverse events between the groups, but FFP alone was associated with more major hemorrhage after administration (52%, OR 5.0, 95% CI 1.6-15.4, P=0.006) and PCC with less (6%, OR 0.1, 95% CI 0.01-0.8, P=0.033). After adjusting for age, admission GCS, initial INR, and bleed type, the use of PCC was associated with a lower risk of death or severe disability at 3-months (adjusted OR 0.02, 95% CI 0.001-0.8, P=0.039), while FFP alone was associated with a higher risk (adjusted OR 51.6, 95% CI 1.2-2163.1, P=0.039). PCC adequately corrected INR without any increase in adverse events compared to FFP and was associated with less major hemorrhage and improved 3-month outcomes in patients with warfarin-associated intracranial hemorrhage.