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Management of CSDH With or Without EMMA- a Randomized Control Trial

Chronic Subdural Hematoma

EMMA-Can is an open-label randomized control trial comparing the recurrence risk in patients with chronic subdural hematoma (CSDH) undergoing standard of care treatment (surgical drainage and/or medical management) with or without embolization of the middle meningeal (EMMA).

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation 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.

Study Location

University of Manitoba
University of Manitoba
Winnipeg, Manitoba
Canada

Contact Study Team

Primary Contact

Jai Shankar, MD

[email protected]
431 373 4164
Backup Contact

Susan Alcock, MN

[email protected]
204 789 3996
Study Sponsored By
University of Manitoba
Participants Required
More Information
Study ID: NCT04750200