Effectiveness of 4-Factor Prothrombin Complex Concentrate with and Without Vitamin K in Managing Warfarin-Associated Major Bleeding

Abstract

Background: Major bleeding is a common and severe complication associated with vitamin K antagonist use. Rapid reversal of anticoagulation is crucial in cases of acute bleeding. Prothrombin complex concentrates (PCC) have emerged as an effective option. This study examines the efficacy of 4-factor PCC (4F-PCC) alone and in combination with vitamin K for International Normalized Ratio (INR) control in patients with life-threatening bleeding due to warfarin. Methods: This retrospective cross-sectional study included 50 patients who presented with bleeding and coagulopathy to the Ondokuz May & imath;s University Health Practice and Research Center Adult Emergency Department between January 1, 2022, and January 1, 2023. Patients were divided into 2 groups based on vitamin K administration within 24 hours: group 1 received only 4F-PCC, while group 2 received both 4F-PCC and vitamin K. Results: The median age of patients was 72 years, 56% were male. The most common indication for warfarin use was heart valve disease (54%). Gastrointestinal hemorrhage was the leading cause of bleeding (44%). Mortality was 26%, with all deaths occurring within 72 hours of admission. Group 2 had significantly lower INR levels at 24th-hour than group 1 (P = .048). No significant differences were found in INR levels between the 1st and 24th hours within either group (P > .05). Conclusion: The study demonstrates that the combination of 4F-PCC and vitamin K is more effective in controlling INR than 4F-PCC alone, though it does not significantly impact rebound INR increases. Further prospective, multicenter studies are needed to confirm these findings and explore long-term outcomes.