PROSPECTIVE EVALUATION OF A FIXED-DOSE 4-FACTOR PROTHROMBIN COMPLEX CONCENTRATE PROTOCOL FOR URGENT VITAMIN K ANTAGONIST REVERSAL

摘要

Background: Four-factor prothrombin complex concentrate (4F-PCC) is the standard of care for reversal of vitamin K antagonists (VKAs). Research has demonstrated noninferior efficacy with the use of lower, fixed-dose strategies for 4F-PCC dosing. Objectives: We compared a fixed-dose 4F-PCC protocol to weight-based dosing at our institution. Methods: This was a multicenter, noninferiority, interventional, quasiexperimental cohort study including subjects who were administered 4F-PCC for VKA reversal. The retrospective cohort consisted of subjects given a weight-based dose of 4F-PCC dependent on international normalized ratio (INR). The prospective cohort was managed with a fixed-dose protocol. The fixed dose was 1500 units of factor IX unless subjects weighed >100 kg or had a baseline INR >7.5, in which case the dose was 2000 units of factor IX. The primary endpoint was achievement of a postinfusion INR of 0.4 for noninferiority). There were no significant differences in 24-h postinfusion INRs, mortality, or venous thromboembolic events. Conclusion: The use of a fixed-dose 4F-PCC protocol is safe and effective for the rapid reversal of VKA-associated anticoagulation. (C) 2019 Elsevier Inc. All rights reserved.