Trial · NCT07898982
Andexanet Alfa for Reversal of Factor Xa Inhibitors in Traumatic Brain Injury: A Retrospective Single-Centre Study
NCT07898982, Completed, University Medical Centre Ljubljana
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Andexanet Alfa for Reversal of Factor Xa Inhibitors in Traumatic Brain Injury: A Retrospective Single-Centre Study. Trials, record NCT07898982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07898982
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Andexanet Alfa for Reversal of Factor Xa Inhibitors in Traumatic Brain Injury: A Retrospective Single-Centre Study
- NCT number
- NCT07898982
- Status
- Completed
- Enrollment
- 34 participants, actual
- Lead sponsor
- University Medical Centre Ljubljana
- Conditions
- Traumatic Brain Injury, Intracranial Hemorrhages
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hemostatic Efficacy | 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 |
| Secondary | All-Cause Mortality during the hospital stay | From enrollment to the hospital discharge | Proportion of patients who died from any cause within hospital stay |
| Secondary | Thrombotic Complications | Up to 30 days after andexanet alfa administration | Proportion of patients experiencing any thrombotic event within 30 days, including deep vein thrombosis (DVT), pulmonary embolism (PE), ischaemic stroke, and myocardial infarction (MI). |
| Secondary | Anti-Factor Xa Activity Reduction | Up to three days after andexanet application | 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. |
| Secondary | Hospital Length of Stay | Up to hospital discharge (estimated up to 90 days after admission) | Duration of hospital length of stay, measured in days from admission |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07898982
GET https://conductscience.org/api/trials/v1/NCT07898982/registered