Predicting outcomes for patients with brain bleeding on specific blood thinners
Forecast of Functional Outcome and Impact of Anti Factor Xa-levels in Patients With Intracerebral Haemorrhage Related to Direct Factor Xa Inhibitors - a Multi-center Cohort Study
Insel Gruppe AG, University Hospital Bern · NCT06383741
This study is testing how well certain blood thinners work for patients who have bleeding in the brain and whether specific treatments can help improve their recovery after 30 days.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT06383741 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the outcomes of patients who experience intracerebral hemorrhage (ICH) while on direct factor Xa inhibitors and dabigatran, which are commonly used for stroke prevention. It aims to assess the hemostatic efficacy of treatments like prothrombin complex concentrate and andexanet alfa, while also evaluating 30-day functional outcomes. The study will measure anti-FXa levels to guide treatment decisions and explore their relationship with hematoma expansion, particularly in patients presenting late after drug intake.
Who should consider this trial
Good fit: Ideal candidates include patients with imaging-proven intracerebral hemorrhage who have been on a factor Xa inhibitor without interruption for more than 48 hours prior to symptom onset.
Not a fit: Patients who have received additional treatment with Vitamin K antagonists or dabigatran will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients experiencing ICH while on anticoagulants, potentially leading to better recovery outcomes.
How similar studies have performed: While there are ongoing studies like ANNEXA-I assessing similar treatment strategies, direct comparative evidence remains limited, making this study's approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Imaging proven intracerebral haemorrhage * Prior therapy with a factor Xa-inhibitor (apixaban, edoxaban or rivaroxaban), not paused for medical/non-medical reasons for more than 48 hours prior to symptom onset * Drug-specific calibrated anti-FXa levels measured on admission * Informed consent (by patient, next-of-kin or deferred consent) Exclusion Criteria: * Additional treatment with Vitamin K antagonist or dabigatran
Where this trial is running
Bern
- Insel Gruppe AG, Inselspital Bern — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: David J. Seiffge — Insel Gruppe AG, University Hospital Bern
- Study coordinator: David J. Seiffge
- Email: david.seiffge@insel.ch
- Phone: +41 31 66 4 12 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intra Cerebral Hemorrhage