Evaluation of Fixed Dose vs Weight-Based Dosing of 4F-PCC in ICH Caused by Factor Xa Inhibitors

Introduction: Factor-Xa-inhibitor associated bleeding can be a life-threatening complication. Four-factor prothrombin complex concentrate can be utilized as a reversal agent. However, there have been few studies examining dosing of this medication specifically in intracranial hemorrhage caused by factor-Xa-inhibitors. With the limited information available, there is a need to evaluate the safety and efficacy of fixed dosing vs weight-based dosing of 4FPCC in intracranial hemorrhage caused by factor-Xa-inhibitors.


Methods: This is a multi-centered retrospective cohort study at 23 hospitals in the Baptist Memorial Healthcare system. Patients aged 18 years or older who received 4FPCC for the reversal of intracranial hemorrhage caused by a factor-Xa-inhibitor from January 2014 to March 2025 at any Baptist Memorial Hospital will be included. Patients will be excluded if they received any other agents for the reversal of factor-Xa, are pregnant, have a history of disseminated intravascular coagulopathy or heparin induced thrombocytopenia, and if repeat imaging was not obtained. The primary endpoint is hemostatic efficacy. The secondary endpoints are hospital mortality and length of stay. Safety outcome is thrombotic events within 30 days. Baseline characteristics and outcomes will be evaluated using ANOVA for continuous data or chi-square test for nominal data.


Results: This trial included 105 patients in total (2000 IU = 35 patients, 25 IU/kg = 35 patients, 50 IU/ kg = 35 patients). Hemostatic efficacy was achieved in 77.1 - 85.7% of patients across all groups with no significant differences found between the groups (p= 0.637). Similarly, there was also not a statistically significant difference in thrombotic events (p=0.057). However, there was a statistically significant difference in hospital mortality (p=0.041) and length of stay (p=0.007).


Conclusions: Fixed dosing versus weight dosing of 4FPCC are similarly efficacious in reversal of factor-Xa-inhibitor associated intracranial hemorrhage.