2025 Southeastern Residency Conference

Title: Prothrombin complex concentrate in obese patients with factor Xa inhibitor-associated bleeding


Authors: Lam Ho, Alyssa Osmonson, John Michael Herndon, Jessica Starr


Objective: To evaluate the effectiveness of weight-based versus fixed-dose 4F-PCC for the reversal of factor Xa inhibitor-associated bleeding in obese patients 


Self-Assessment Question: Based on the result of this study, patient receiving weight-based regimen developed more thrombotic event?


Background: Many studies have demonstrated the effectiveness of 4F-PCC in reversing anticoagulation and managing bleeding associated with factor Xa inhibitors; however, there is a lack of data to guide optimal dosing in obese patients. Specifically, the role of fixed-dosing in this population requires further exploration. 


Methods: This a multicenter, retrospective cohort study conducted from January 2016 through April 2024. Electronic medical records of obese patients (BMI ≥30 kg/m²) receiving apixaban, rivaroxaban, or edoxaban who were treated with 4F-PCC were reviewed.  Patients were included if they were ≥18 years of age and had major bleeding associated with factor Xa inhibitors.  Major bleeding was defined as intracranial or critical-site hemorrhages, hemodynamic instability (SBP <90 mmHg, SBP drop >40 mmHg, HR >100 bpm), hemoglobin decrease >2 g/dL, or need for ≥2 PRBC units. Exclusion criteria included pregnant patients, and those transferred to an outside health system. The primary outcome is all-cause mortality. Secondary outcomes include hematoma expansion (≥6 mL or ≥33% increase), thromboembolic events, the need for a second 4F-PCC dose, and 48-hour transfusion requirements.


Results: Seventy-seven patients were included in the study. Mortality rates were 25% (n=12) in the fixed-dose group and 44.8% (n=13) in the weight-based group (p=0.0718). No thrombotic events were observed in either group. Two patients in the weight-based group required a second dose (p=0.0653). Transfusion within 48 hours was needed in 22.9% (n=11) of patients in the fixed-dose group and 20.1% (n=6) in the weight-based group (p=0.8194). Hematoma expansion occurred in one patient receiving weight-based dosing (p=0.5464).


Conclusions: This study found no difference in mortality between fixed-dose and weight-based dosing regimens. No thrombotic events were observed in either group. Larger studies are needed to evaluate the safety and efficacy of fixed-dose versus weight-based 4F-PCC for factor Xa inhibitors-associated bleeding in obese patients.