Status:
ACTIVE_NOT_RECRUITING
Management of CSDH With or Without EMMA- a Randomized Control Trial
Lead Sponsor:
University of Manitoba
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
EMMA-Can is a prospective randomized open-label, blinded end point (PROBE) study, that will assess the recurrence risk and safety of embolization of the middle meningeal (EMMA) when added to standard ...
Detailed Description
All patients in clinical need of surgical drainage for the CSDH will be randomized in our study. Patients that present in the Emergency Department (ED) or neurosurgery clinic will be assessed for stan...
Eligibility Criteria
Inclusion
- Premorbid Modified Rankin Scale of ≤2;
- Patients with unilateral symptomatic primary or recurrent CSDH \>10 mm in thickness on CT head undergoing surgical drainage;
- CT Angiogram of head and neck which favors vascular access for EMMA and lacks dangerous anatomic variations;
- Patients over 18 years of age; no upper age limit.
Exclusion
- If informed consent cannot be obtained from the patients or their substitute decision makers;
- Patients with bilateral symptomatic CSDH;
- CTA showing persistent communication between branches of middle meningeal artery and that of internal carotid arteries;
- Contraindication to the embolization procedure such as severe renal dysfunction (eGFR\<30), or pregnancy;
- Life expectancy \< 6 months;
- Known allergy to Onyx;
- Acute subdural hematoma with homogenous hyperdensity on CT scan;
- 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;
- Patients needing treatment with 2 weeks of dexamethasone or tranexamic acid will be contraindicated in the study patients to avoid confounding.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT04750200
Start Date
August 1 2021
End Date
March 31 2026
Last Update
December 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 3P5