Comparing treatments for chronic subdural hematoma with and without embolization

Management of Chronic Subdural Hematoma With or Without Embolization of Middle Meningeal Artery in Canada (EMMA-Can)- A Randomized Control Trial.

This study is testing if adding a special procedure to the usual treatment for chronic subdural hematoma can lower the chances of it coming back in patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Manitoba (Academic / other)
• Locations: 1 site (Winnipeg, Manitoba)
• Trial ID: NCT04750200 on ClinicalTrials.gov

What this trial studies

This trial evaluates the recurrence risk of chronic subdural hematoma (CSDH) in patients receiving standard treatment, either surgical drainage or medical management, with or without the addition of embolization of the middle meningeal artery (EMMA). Patients presenting to the Emergency Department or neurosurgery clinic will be assessed for eligibility and randomized into either the control group or the interventional group. The interventional group will receive standard care followed by EMMA within 48 hours. The study aims to track complications and changes in clinical status, focusing on the recurrence rate at 90 days post-treatment.

Who should consider this trial

Good fit: Ideal candidates are patients with chronic subdural hematoma requiring surgical intervention or medical management, presenting with specific symptoms and meeting eligibility criteria.

Not a fit: Patients with contraindications to embolization, severe renal dysfunction, or those with a life expectancy of less than six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could reduce the recurrence of chronic subdural hematoma, improving patient outcomes and quality of life.

How similar studies have performed: While the approach of using embolization in this context is innovative, similar studies have shown promise in reducing recurrence rates in related conditions.

Eligibility criteria

Inclusion Criteria:

1. Modified Rankin Scale of ≤2 at baseline
2. Patients requiring surgery or has at least 10 mm of CSDH on CT head and has one or more symptoms attributable to CSDH, including headache, cognitive impairment, ataxia, seizure, focal neurologic deficit, or decreased consciousness.
3. CT Angiogram of head and neck which favors vascular access for EMMA and lacks dangerous anatomic variations.

Exclusion Criteria:

1. If informed consent can not be obtained from the patients or their substitute decision makers.
2. CT Angiogram showing dangerous communication between middle meningeal artery and branches of internal carotid arteries.
3. Contraindication to the embolization procedure such as severe renal dysfunction, or pregnancy
4. Life expectancy \< 6 months.
5. Known allergy to embolic agent
6. Acute subdural hematoma with homogenous hyperdensity on CT scan.
7. Secondary CSDH that may likely be due to the underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or prior craniotomy.

Where this trial is running

Winnipeg, Manitoba

• University of Manitoba — Winnipeg, Manitoba, Canada (Recruiting)

Study contacts

• Principal investigator: Jai JS Shankar, MD — University of Manitoba
• Study coordinator: Jai Shankar, MD

Conditions Chronic Subdural Hematoma; chronic subdural hematoma, Middle Meningeal embolization