Traumatic Brain InjuryAA-TBINCT07898982
Andexanet Alfa for Reversal of Factor Xa Inhibitors in Traumatic Brain Injury: A Retrospective Single-Centre Study
An observational study of Traumatic Brain Injury and Intracranial Hemorrhages, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Intracranial Hemorrhages
- How many people
- 34 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Aug 2024to 16 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥18 years
- Traumatic brain injury with Glasgow Coma Scale score 7-15
- Active treatment with a direct factor Xa inhibitor (apixaban, rivaroxaban)
- CT-confirmed traumatic intracranial haemorrhage (intraparenchymal haemorrhage, subdural haematoma, epidural haematoma, subarachnoid haemorrhage, or combination)
- Received andexanet alfa for anticoagulation reversal
- Baseline and at least one follow-up CT scan available for comparison
Who cannot join
- Glasgow Coma Scale <7 or GCS 16 (i.e., GCS 3-6 indicating severe TBI or GCS 16 indicating no significant TBI)
- Anticoagulation with agents other than direct factor Xa inhibitors (e.g., dabigatran, warfarin)
- Concurrent use of other reversal agents (e.g., four-factor prothrombin complex concentrate) in the same treatment episode
- No follow-up CT imaging available
- Incomplete medical records precluding primary outcome assessment
- Non-traumatic intracranial haemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Background and Rationale:___Factor Xa inhibitors are among the most commonly prescribed anticoagulants and are widely used in elderly patients with atrial fibrillation and venous thromboembolism. When these patients sustain traumatic brain injury, the ongoing anticoagulant effect significantly increases the risk of haematoma expansion, neurological deterioration, and mortality. Andexanet alfa was developed as a specific reversal agent for FXa inhibitors and gained initial approval following the ANNEXA-4 trial. The ANNEXA-4 final report demonstrated hemostatic efficacy of 82% in patients with intracranial haemorrhage (ICH). [⚠ check for citation marker here] The ANNEXA-I randomised trial subsequently confirmed superiority of andexanet alfa over usual care (predominantly four-factor prothrombin complex concentrate, 4F-PCC) for spontaneous ICH, with a 67.0% versus 53.1% rate of hemostatic efficacy, though it noted a higher rate of thrombotic events in the andexanet group (10.3% versus 5.6%). [⚠ check for citation marker here] Real-world observational studies have yielded variable efficacy rates in mixed ICH populations, ranging from 67% to 83% depending on the cohort and assessment methodology. Systematic reviews and meta-analyses comparing andexanet alfa with 4F-PCC for FXa inhibitor-associated ICH have reported broadly comparable hemostatic efficacy, with some analyses suggesting marginally better haematoma control with andexanet alfa but a potentially higher thrombotic risk. Clinical guidelines acknowledge the limited evidence base for TBI-specific reversal and recognise the need for further data in this population. Notably, several studies have suggested that patients with traumatic ICH on FXa inhibitors may have lower rates of haematoma expansion than spontaneous ICH patients even without specific reversal, raising questions about optimal management strategies. To date, no dedicated study has systematically evaluated andexanet alfa specifically in a TBI cohort using standardised CT-based hemostatic efficacy criteria across all traumatic ICH subtypes (IPH, SDH, EDH, SAH). Study Design:___This is a retrospective observational cohort study conducted at a single tertiary trauma centre. All adult patients (age ≥18 years) admitted with traumatic brain injury (Glasgow Coma Scale 7-15) who were receiving a direct FXa inhibitor (apixaban, rivaroxaban) and who received andexanet alfa for anticoagulation reversal during the study period were identified through pharmacy dispensing records.
- Conditions
- Traumatic Brain Injury, Intracranial Hemorrhages
- Keywords
- andexanet alfa, factor Xa inhibitor reversal, traumatic brain injury, intracranial haemorrhage, hemostatic efficacy, NOAC reversal, apixaban, rivaroxaban
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Andexanet Alfa Recipients | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 24 hours of andexanet alfa administration
Secondary outcomes (4)
All-Cause Mortality during the hospital stay
Proportion of patients who died from any cause within hospital stay
Measured: From enrollment to the hospital discharge
Thrombotic Complications
Proportion of patients experiencing any thrombotic event within 30 days, including deep vein thrombosis (DVT), pulmonary embolism (PE), ischaemic stroke, and myocardial infarction (MI).
Measured: Up to 30 days after andexanet alfa administration
Anti-Factor Xa Activity Reduction
Change in anti-factor Xa activity from baseline (pre-bolus) to post-bolus and post-infusion time points, expressed as absolute change and percentage reduction.
Measured: Up to three days after andexanet application
Hospital Length of Stay
Duration of hospital length of stay, measured in days from admission
Measured: Up to hospital discharge (estimated up to 90 days after admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Aug 2024
- Primary completion1 Aug 2026
- Study completion16 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Primož Gradišek, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898982
- Sponsor's protocol ID
- UKC-KSEV-13-090925
- Acronym
- AA-TBI
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35743469Frol 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.
PubMed 37133623Milling 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.
PubMed 36802876Connolly 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.
PubMed 38749032
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07898982
- Acronym / sponsor ID
- AA-TBI / UKC-KSEV-13-090925
- Conditions
- Traumatic Brain Injury, Intracranial Hemorrhages
- Keywords
- andexanet alfa, factor Xa inhibitor reversal, traumatic brain injury, intracranial haemorrhage, hemostatic efficacy, NOAC reversal, apixaban, rivaroxaban
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale:___Factor Xa inhibitors are among the most commonly prescribed anticoagulants and are widely used in elderly patients with atrial fibrillation and venous thromboembolism. When these patients sustain traumatic brain injury, the ongoing anticoagulant effect significantly increases the risk of haematoma expansion, neurological deterioration, and mortality. Andexanet alfa was developed as a specific reversal agent for FXa inhibitors and gained initial approval following the ANNEXA-4 trial. The ANNEXA-4 final report demonstrated hemostatic efficacy of 82% in patients with intracranial haemorrhage (ICH). [⚠ check for citation marker here] The ANNEXA-I randomised trial subsequently confirmed superiority of andexanet alfa over usual care (predominantly four-factor prothrombin complex concentrate, 4F-PCC) for spontaneous ICH, with a 67.0% versus 53.1% rate of hemostatic efficacy, though it noted a higher rate of thrombotic events in the andexanet group (10.3% versus 5.6%). [⚠ check for citation marker here] Real-world observational studies have yielded variable efficacy rates in mixed ICH populations, ranging from 67% to 83% depending on the cohort and assessment methodology. Systematic reviews and meta-analyses comparing andexanet alfa with 4F-PCC for FXa inhibitor-associated ICH have reported broadly comparable hemostatic efficacy, with some analyses suggesting marginally better haematoma control with andexanet alfa but a potentially higher thrombotic risk. Clinical guidelines acknowledge the limited evidence base for TBI-specific reversal and recognise the need for further data in this population. Notably, several studies have suggested that patients with traumatic ICH on FXa inhibitors may have lower rates of haematoma expansion than spontaneous ICH patients even without specific reversal, raising questions about optimal management strategies. To date, no dedicated study has systematically evaluated andexanet alfa specifically in a TBI cohort using standardised CT-based hemostatic efficacy criteria across all traumatic ICH subtypes (IPH, SDH, EDH, SAH). Study Design:___This is a retrospective observational cohort study conducted at a single tertiary trauma centre. All adult patients (age ≥18 years) admitted with traumatic brain injury (Glasgow Coma Scale 7-15) who were receiving a direct FXa inhibitor (apixaban, rivaroxaban) and who received andexanet alfa for anticoagulation reversal during the study period were identified through pharmacy dispensing records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Andexanet Alfa Recipients | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Age ≥18 years
- Traumatic brain injury with Glasgow Coma Scale score 7-15
- Active treatment with a direct factor Xa inhibitor (apixaban, rivaroxaban)
- CT-confirmed traumatic intracranial haemorrhage (intraparenchymal haemorrhage, subdural haematoma, epidural haematoma, subarachnoid haemorrhage, or combination)
- Received andexanet alfa for anticoagulation reversal
Key exclusion criteria (6 listed)
- Glasgow Coma Scale <7 or GCS 16 (i.e., GCS 3-6 indicating severe TBI or GCS 16 indicating no significant TBI)
- Anticoagulation with agents other than direct factor Xa inhibitors (e.g., dabigatran, warfarin)
- Concurrent use of other reversal agents (e.g., four-factor prothrombin complex concentrate) in the same treatment episode
- No follow-up CT imaging available
- Incomplete medical records precluding primary outcome assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemostatic Efficacy
Time frame: Within 24 hours of andexanet alfa administration
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
4 secondary outcomes
All-Cause Mortality during the hospital stay
Time frame: From enrollment to the hospital discharge
Thrombotic Complications
Time frame: Up to 30 days after andexanet alfa administration
Anti-Factor Xa Activity Reduction
Time frame: Up to three days after andexanet application
Hospital Length of Stay
Time frame: Up to hospital discharge (estimated up to 90 days after admission)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 35743469Rauch 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.
- Background: PubMed 37133623Frol 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.
- Background: PubMed 36802876Milling 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.
- Background: PubMed 38749032Connolly 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Intracranial Hemorrhages, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostatic Efficacy (time frame: Within 24 hours of andexanet alfa administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07898982, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.