Embolization treatment for chronic subdural hematoma in Canada
Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada -EMMA-Can
This study is testing a new procedure to see if blocking a specific artery can help people with chronic subdural hematoma avoid having it come back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Locations | 1 site (Winnipeg MB, Manitoba) |
| Trial ID | NCT04923984 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of embolizing the middle meningeal artery as a treatment for chronic subdural hematoma (CSDH). Patients presenting with CSDH to the emergency room or neurosurgical outpatient clinic will be screened for enrollment. Those who consent will undergo the embolization procedure, and their outcomes will be monitored through follow-up CT scans and clinical assessments at 1, 3, and 6 months post-treatment. The study aims to determine if this approach reduces the recurrence rate of CSDH, especially in patients at higher risk of recurrence.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with chronic subdural hematoma who present to the emergency room or neurosurgical clinic.
Not a fit: Patients who cannot provide informed consent or have a known allergy to the embolic agent will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of chronic subdural hematoma in patients.
How similar studies have performed: While embolization techniques have been explored in other studies, this specific approach for chronic subdural hematoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic. Exclusion Criteria: * If informed consent cannot be obtained from the patient or their substitute decision maker. * Known allergy to liquid embolic agent
Where this trial is running
Winnipeg MB, Manitoba
- Health Sciences centre — Winnipeg MB, Manitoba, Canada (Recruiting)
Study contacts
- Principal investigator: Jai Shankar, MD — University of Manitoba
- Study coordinator: Jai Shankar, MD
- Email: shivajai1@gmail.com
- Phone: 4313734164
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.