(1013) Fixed-Dose 4F-PCC for Reversal of Factor Xa Inhibitor for Intracranial Hemorrhage

Introduction: Intracranial hemorrhage (ICH) can present as a significant complication in patients on oral anticoagulants such as factor Xa inhibitors (FXaIs). Rapid anticoagulation reversal is critical to patient outcomes. While four factor prothrombin complex concentrates (4F-PCC) are recommended for this purpose, the optimal dosing strategy has not been established. Protocols vary widely, ranging from fixed low doses to traditional weight-based dosing. Originally, the standard 4F-PCC dosing protocol was 50 units/kilogram. Emerging evidence from observational studies indicate that lower fixed doses may yield similar clinical outcomes. This study compared the safety and efficacy of a fixed 2,000-unit dose of 4F-PCC versus the traditional weight-based dosing in patients with FXaI-associated ICH.

Methods: This retrospective study conducted at a level 1 trauma and comprehensive stroke center included adult patients who received 4F-PCC for FXaI-associated ICH from January 2022 to September 2023. Patients were divided into a fixed 2,000-unit dose group or a weight-based 50 units/kilogram dose group based on the dose of 4F-PCC received. The primary outcome was the stability of ICH on follow-up CT scans, with secondary outcomes including mortality, thrombotic events, and ICU/hospital lengths of stay (LOS).

Results: A total of 82 patients were included, with 41 in each dosing group. No significant difference was observed in hemorrhage stability between the fixed-dose vs weight-based dosing group [36/41 (87.8%) vs 36/41 (87.8%), p >0.99]. Secondary endpoints were not significant between groups, including mortality rates [6/41 (14.6%) vs 6/41 (14.6%), p >0.99], thrombotic events [1/41 (2.4%) vs 3/41 (7.3%), p=0.305], ICU LOS [3 days (1-4) vs 3.8 days (1-4), p=0.364], and hospital LOS [4.6 days (3-7) vs 4.8 days (2.5-9), p=0.722]. The fixed-dose group received a significantly lower dose per kilogram compared to the weight-based group, (26.5 units/kg vs 49.0 units/kg) without affecting the clinical outcomes.

Conclusions: The study suggests that a fixed 2,000-unit dose of 4F-PCC is as effective and safe as weight-based dosing for reversing FXaI-associated ICH. This fixed-dose approach could offer a cost-effective and simplified alternative in clinical practice.