Low-dose 4F-PCC (25 units/kg) demonstrated similar hemostatic efficacy at 24 hours compared to high-dose 4F-PCC (50 units/kg) for FXaI-associated ICH (92% vs. 86%; p=0.50).
Cohort (n=120)
No
Does low-dose 4F-PCC (25 units/kg) provide similar hemostatic effectiveness compared to high-dose 4F-PCC (50 units/kg) in adults with factor Xa inhibitor-associated intracerebral hemorrhage?
Low-dose 4F-PCC (25 units/kg) provides similar hemostatic efficacy to high-dose (50 units/kg) for reversing factor Xa inhibitors in intracerebral hemorrhage, while offering significant cost savings.
Tasa de eventos absoluta: 92% vs 86%
valor p: p=0.50
Introduction: Four-factor prothrombin complex concentrate (4F-PCC) is used off-label for factor Xa inhibitor (FXaI) -associated life-threatening hemorrhages. The American Stroke Association Intracerebral Hemorrhage (ICH) 2022 Guidelines consider 4F-PCC use in FXaI-associated ICH but do not specify a dose. Several studies have demonstrated similar efficacy and cost savings with low-dose 4F-PCC (25 units/kg) compared to high-dose 4F-PCC (50 units/kg), regardless of bleed location. The purpose of this study was to determine if there was a difference in hemostatic effectiveness between 25 units/kg versus 50 units/kg of 4F-PCC in FXaI reversal in ICH. Methods: This was a single-center, retrospective cohort study of adult patients who received 4F-PCC in the emergency department for reversal of FXaI-related ICH from February 1, 2020, to January 10, 2025. The primary outcome evaluated the hemostatic effectiveness within 24 hours of 4F-PCC administration, determined by improvement or worsening of hematoma size based on radiologist impression of computed tomography imaging. Secondary outcomes included the cumulative incidence of thromboembolic events (e. g. , deep vein thrombosis, ischemic stroke) occurring 30 days after 4F-PCC, hospital mortality, hospital length of stay, average blood pressure within goal (defined as a systolic less than 140 mmHg, 24 hours-post 4F-PCC), and cost of dose. Results: A total of 120 adult patients who received 4F-PCC for FXaI-associated ICH were included in the analysis. Hemostasis was evaluated in 113 patients with 24-hour post-4PCC imaging available. Hemostatic efficacy at 24 hours (92% vs. 86%; p=0. 50) and 30-day thromboembolic events (5. 4% vs. 7. 2%; p=0. 64) were similar between low- and high-dose groups. There was a higher incidence of in-hospital mortality among the high-dose group compared to the low-dose group (8. 1% vs. 24. 1%, p=0. 04). However, patients in the high-dose group were noted to have more severe injuries upon presentation. The cost per dose was notably higher in the high-dose group (4, 842. 41 vs. 8, 156. 02). Conclusions: The findings of this study add to existing literature supporting a 25 units/kg dose as an effective alternative to 50 units/kg 4F-PCC dosing and provides cost savings for the reversal of FXaI in ICH.
Pecoraro et al. (Sun,) conducted a cohort in Factor Xa inhibitor-associated intracerebral hemorrhage (n=120). Low-dose 4F-PCC vs. High-dose 4F-PCC (50 units/kg) was evaluated on Hemostatic effectiveness within 24 hours of 4F-PCC administration (p=0.50). Low-dose 4F-PCC (25 units/kg) demonstrated similar hemostatic efficacy at 24 hours compared to high-dose 4F-PCC (50 units/kg) for FXaI-associated ICH (92% vs. 86%; p=0.50).