Fixed vs Weight-Based Dosing of Four-Factor Prothrombin Complex Concentrate for Factor Xa Inhibitor Reversal in Patients With a Non-Neurologic Hemorrhage

Background: There is a growing body of evidence to support that utilizing fixed dose vs weight-based dosing of Four-Factor prothrombin complex concentrate (4F-PCC) for Factor Xa inhibitor (FXaI) reversal is safe and efficacious. Objectives: The primary objective of this study was the rate of hemostatic efficacy of weight-based (50 units/kg) vs fixed dose (2000 units) 4F-PCC for FXaI reversal in patients presenting with a non-neurologic hemorrhage. Methods: This was a multi-center, retrospective chart review from January 21, 2020, to January 21, 2022. Patients were included if they were greater than or equal to 18 years of age and received one dose of 4F-PCC for FXaI reversal for a non-neurologic bleed. Hemostatic efficacy for this study was defined as the absence of hemorrhagic progression confirmed with imaging, >2 g/dl decrease in Hgb within 6 hours of 4F-PCC administration, reports of further significant bleeding in chart note documentation within 48 hours and a maintained or increased anti-factor Xa level from baseline. Results: Fifty-nine patients were included in this study (29 in the weight-based group and 30 in the fixed dose group). Rate of hemostatic efficacy was similar between fixed and weight-based dosing (93.3% vs 93.1% P = 1). Conclusions: This study adds to current evidence suggesting that a fixed dose 4F-PCC is both safe and efficacious for FXaI reversal in non-neurologic bleeds.