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AA-TBI
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
Sponsor study identifier
observational
34
1 country
1
Study Start
August 1, 2024
Actual (reported)Primary Completion
August 1, 2026
Actual (reported)Study Completion
September 16, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 16, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2024
Actual (reported)August 1, 2026
Actual (reported)September 16, 2026
Actual (reported)October 5, 2026
Actual (reported)October 27, 2026
Actual (reported)Hemostatic Efficacy
Proportion of patients achieving Excellent or Good hemostatic efficacy on follow-up CT imaging within 24 hours of andexanet alfa administration. Hemostatic efficacy is classified based on the percentage change in haematoma volume (for intraparenchymal haemorrhage) or maximum thickness (for subdural haematoma, epidural haematoma, or subarachnoid haemorrhage) between baseline CT and follow-up CT: * Excellent: ≤20% increase in haematoma volume or thickness * Good: 21-35% increase in haematoma volume or thickness * Poor: \>35% increase in haematoma volume or thickness. For patients with multiple haemorrhage subtypes, the dominant lesion determines classification. This scale is consistent with modified criteria used in the ANNEXA-4 trial
Within 24 hours of andexanet alfa administration
All-Cause Mortality during the hospital stay
From enrollment to the hospital discharge
Thrombotic Complications
Up to 30 days after andexanet alfa administration
Anti-Factor Xa Activity Reduction
Up to three days after andexanet application
Hospital Length of Stay
Up to hospital discharge (estimated up to 90 days after admission)
Adult patients (age ≥18 years) with traumatic brain injury (Glasgow Coma Scale 7-15) who were receiving a direct factor Xa inhibitor (apixaban, rivaroxaban) at the time of injury and who received andexanet alfa for reversal of anticoagulation following CT-confirmed traumatic intracranial haemorrhage at UMC ljubljana, Slovenia, \[2024-2026\]. All patients had a baseline CT scan performed prior to or shortly after andexanet alfa administration and at least one follow-up CT scan within 24 hours. The cohort includes patients with all subtypes of traumatic intracranial haemorrhage, including intraparenchymal haemorrhage, subdural haematoma, epidural haematoma, subarachnoid haemorrhage, or combinations thereof. Andexanet alfa was dosed according to the product labelling based on the specific FXa inhibitor, dose, and timing of the last dose.
Adult patients (age ≥18 years) with traumatic brain injury presenting to a single tertiary trauma centre who were on direct factor Xa inhibitor anticoagulation (apixaban, rivaroxaban) at the time of injury and received andexanet alfa for reversal of anticoagulation. The study population is drawn from consecutive patients treated at the institution during the study period.
University Medical Centre Ljubljana
Ljubljana, 1000, Slovenia
Rauch S, Muller HP, Dreyhaupt J, Ludolph AC, Kassubek J, Althaus K. Andexanet Alfa for Reversal of Factor Xa Inhibitors in Intracranial Hemorrhage: Observational Cohort Study. J Clin Med. 2022 Jun 13;11(12):3399. doi: 10.3390/jcm11123399.
Frol S, Oblak JP, Sabovic M, Kermer P. Andexanet Alfa to Reverse the Effect of Factor Xa Inhibitors in Intracranial Hemorrhage. CNS Drugs. 2023 Jun;37(6):477-487. doi: 10.1007/s40263-023-01006-7. Epub 2023 May 3.
34 participants (actual enrollment reported by the registry).
First Submitted
October 5, 2026
First Posted
October 27, 2026
Study Start
August 1, 2024
Actual (reported)Contact the study team to confirm eligibility.
Milling TJ Jr, Middeldorp S, Xu L, Koch B, Demchuk A, Eikelboom JW, Verhamme P, Cohen AT, Beyer-Westendorf J, Gibson CM, Lopez-Sendon J, Crowther M, Shoamanesh A, Coppens M, Schmidt J, Albaladejo P, Connolly SJ; ANNEXA-4 Investigators. Final Study Report of Andexanet Alfa for Major Bleeding With Factor Xa Inhibitors. Circulation. 2023 Mar 28;147(13):1026-1038. doi: 10.1161/CIRCULATIONAHA.121.057844. Epub 2023 Feb 20.
Connolly SJ, Sharma M, Cohen AT, Demchuk AM, Czlonkowska A, Lindgren AG, Molina CA, Bereczki D, Toni D, Seiffge DJ, Tanne D, Sandset EC, Tsivgoulis G, Christensen H, Beyer-Westendorf J, Coutinho JM, Crowther M, Verhamme P, Amarenco P, Roine RO, Mikulik R, Lemmens R, Veltkamp R, Middeldorp S, Robinson TG, Milling TJ Jr, Tedim-Cruz V, Lang W, Himmelmann A, Ladenvall P, Knutsson M, Ekholm E, Law A, Taylor A, Karyakina T, Xu L, Tsiplova K, Poli S, Kallmunzer B, Gumbinger C, Shoamanesh A; ANNEXA-I Investigators. Andexanet for Factor Xa Inhibitor-Associated Acute Intracerebral Hemorrhage. N Engl J Med. 2024 May 16;390(19):1745-1755. doi: 10.1056/NEJMoa2313040.
Primary Completion
August 1, 2026
Actual (reported)Study Completion
September 16, 2026
Actual (reported)Last Updated
October 27, 2026
Record last verified: 2026-10
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