Management of CSDH With or Without EMMA- a Randomized Control Trial
Chronic Subdural HematomaEMMA-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).
null
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 ManitobaWinnipeg, Manitoba
Canada
Contact Study Team
- Study Sponsored By
- University of Manitoba
- Participants Required
- More Information
- Study ID:
NCT04750200