Clinical Research Directory

Andexanet Alfa for Reversal of Factor Xa Inhibitors in Traumatic Brain Injury: A Retrospective Single-Centre Study

Sponsor: University Medical Centre Ljubljana

Summary

Elderly patients on direct oral anticoagulants (DOACs), specifically factor Xa (FXa) inhibitors such as apixaban and rivaroxaban are at elevated risk of haematoma expansion following traumatic brain injury (TBI). Andexanet alfa is a recombinant modified factor Xa decoy protein that directly reverses the anticoagulant effect of FXa inhibitors. The pivotal ANNEXA-4 single-arm trial reported hemostatic efficacy of approximately 82% in the overall cohort and 82.9% among patients with intracranial haemorrhage (ICH). The subsequent ANNEXA-I randomised controlled trial demonstrated 67.0% hemostatic efficacy with andexanet alfa compared with 53.1% in the usual-care group (adjusted difference 13.4 percentage points; p=0.003) among patients with spontaneous ICH. However, both landmark trials were focused predominantly on spontaneous ICH, and TBI-specific real-world data on andexanet alfa remain limited. This retrospective single-centre cohort study evaluates the hemostatic efficacy and safety of andexanet alfa in adult patients with traumatic intracranial haemorrhage who were received FXa inhibitor anticoagulation. All patients had a baseline computed tomography (CT) scan and at least one follow-up CT within 24 hours of andexanet alfa administration. The primary outcome is the proportion of patients achieving excellent or good hemostatic efficacy, defined by the percentage change in haematoma volume (for intraparenchymal haemorrhage, IPH) or maximum thickness (for subdural haematoma, SDH; epidural haematoma, EDH; or subarachnoid haemorrhage, SAH) between baseline and follow-up CT: Excellent (≤20% increase), Good (21-35% increase), or Poor (\>35% increase). Key secondary outcomes include 30-day all-cause mortality, thrombotic complications (deep vein thrombosis, pulmonary embolism, ischaemic stroke, myocardial infarction), reduction in anti-factor Xa activity, neurosurgical intervention rate, and hospital and ICU length of stay.

Official title: Hemostatic Efficacy and Safety of Andexanet Alfa for Reversal of Factor Xa Inhibitor-Associated Intracranial Haemorrhage in Traumatic Brain Injury: A Retrospective Single-Centre Cohort Study

Key Details

Conditions

Locations (1)