Preventing repeat bleeding in patients with chronic subdural hematoma
Official title: Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)
Run by Unfallkrankenhaus Berlin · NCT05327933 · Data updated 2026-11-12
This study is testing if a special procedure to block blood vessels can help adults who have had surgery for chronic subdural hematoma avoid getting bleeding again.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 154 (estimated) |
| Sponsor | Unfallkrankenhaus Berlin Academic / other |
| Locations | 1 site (Berlin, State of Berlin) |
| Status | Recruiting |
| Started | May 26, 2022 |
| Main results expected | October 2025 |
| Study ends | October 2025 |
| Registry record updated | March 30, 2025 |
| Trial ID | NCT05327933 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have undergone burr hole trepanation for chronic subdural hematoma.
✕Probably not a fit
Patients who have not undergone surgical treatment for cSDH or those with acute or other types of hematomas may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of middle meningeal artery embolization in preventing recurrences of chronic subdural hematoma (cSDH) in adult patients who have already undergone initial surgery. Participants will be randomly assigned to either a control group receiving standard treatment or a treatment group undergoing additional embolization to block small blood vessels in the skull. The procedure involves using X-rays and a contrast medium to guide a fine tube into the affected vessels. The goal is to determine if this additional intervention can significantly reduce the risk of recurrent bleeding.
Why it matters
Potential benefit: If successful, this approach could significantly lower the recurrence rates of chronic subdural hematoma, improving patient outcomes and reducing the need for repeat surgeries.
How similar studies have gone: While the approach of embolization in this context is relatively novel, similar studies have shown promise in other vascular conditions, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who have undergone surgery by means of one or more burr hole trepanations during the first manifestation of a cSDH (unihemispherical or bihemispherical) detected by computed tomography or magnetic resonance tomography 2. Age ≥18 years 3. Sufficient compliance and ability to consent 4. Patient's informed consent for surgical as well as endovascular interventional procedure and participation in the study Exclusion Criteria: 1. Conservatively treated cSDH 2. Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma 3. Surgical technique: craniotomy, craniectomy, bilateral burr hole trepanation 4. Angiography cannot be performed within 72 hours after surgery 5. Age \<18 years 6. Supervisory relationship 7. Pregnancy 8. Lack of informed consent 9. Lack of compliance 10. Homozygous factor XIII deficiency with residual activity \<10%
Where it's running
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Unfallkrankenhaus Berlin
Berlin, State of Berlin, Germany Recruiting
Study contacts
- Study coordinator: Johannes Lemcke, PD Dr. med.
- Email: johannes.lemcke@ukb.de
- Phone: 00493056813701
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using Tranexamic Acid to Prevent Surgery for Chronic Subdural Hematoma
This study is testing if tranexamic acid can help older patients with chronic subdural hematoma avoid surgery and improve their overall health.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.