Embolization of the middle meningeal artery for chronic subdural hematoma treatment
Improving the Outcome of Chronic Subdural Hematoma by Embolization of Middle Meningeal Artery (ELIMINATE)
This study tests if blocking a specific artery can help older patients with chronic subdural hematomas avoid more surgeries and improve their daily lives after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT04511572 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of embolizing the middle meningeal artery as an additional treatment for patients undergoing surgery for chronic subdural hematomas (cSDH). The primary objective is to determine if this approach reduces the rate of recurrent surgeries, which can be particularly undesirable in elderly patients. Secondary objectives include assessing improvements in quality of life and daily living activities post-treatment. The study involves patients with CT-confirmed cSDH who are symptomatic and require surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are elderly patients with CT-confirmed chronic subdural hematomas who are symptomatic and require surgical treatment.
Not a fit: Patients with significant contraindications to angiography or structural causes for subdural hemorrhage may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of chronic subdural hematomas and improve the quality of life for affected patients.
How similar studies have performed: Previous case reports and larger series have shown promising results with similar embolization techniques, suggesting potential effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * · CT-confirmed diagnosis of chronic Subdural Hematoma; * Primary surgical treatment based on clinical symptoms (progressive neurological deficits). Exclusion Criteria: * · Significant contraindication to angiography (eg. allergy for contrast); * Structural causes for subdural hemorrhage, e.g. arachnoid cysts, cortical vascular malformations and a history of cranial surgery in the previous 365 days; * Inability to obtain informed consent from the patient or legal representative (when the patient has a depressed level of consciousness), including language barrier; * Monocular blindness on contralateral side of the hematoma;
Where this trial is running
Amsterdam
- Amsterdam university medical Centers — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Dagmar Verbaan, PhD
- Email: d.verbaan@amsterdamumc.nl
- Phone: +31205663316
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.