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Clinical Trials in Canada / NCT04750200
Active, not recruiting Not applicable

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

NCT04750200 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2021-08-01
Last updated
2026-04-28

Condition(s) studied

Chronic Subdural Hematoma

Investigational drug(s) / intervention(s)

Embolization of the Middle Meningeal Artery

Embolization of the Middle Meningeal Artery: EMMA is performed inside of the blood vessels where tiny catheters are used to deliver a liquid embolic agent (Onyx) to block small blood vessels supplying the brain coverings.

Study 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 of care treatment (surgical drainage) of chronic subdural hematoma (CSDH) compared to surgical treatment alone.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Premorbid Modified Rankin Scale of ≤2; 2. Patients with unilateral symptomatic primary or recurrent CSDH \>10 mm in thickness on CT head undergoing surgical drainage; 3. CT Angiogram of head and neck which favors vascular access for EMMA and lacks dangerous anatomic variations; 4. Patients over 18 years of age; no upper age limit. Exclusion Criteria: 1. If informed consent cannot be obtained from the patients or their substitute decision makers; 2. Patients with bilateral symptomatic CSDH; 3. CTA showing persistent communication between branches of middle meningeal artery and that of internal carotid arteries; 4. Contraindication to the embolization procedure such as severe renal dysfunction (eGFR\<30), or pregnancy; 5. Life expectancy \< 6 months; 6. Known allergy to Onyx; 7. Acute subdural hematoma with homogenous hyperdensity on CT scan; 8. 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; 9. Patients needing treatment with 2 weeks of dexamethasone or tranexamic acid will be contraindicated in the study patients to avoid confounding.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of Manitoba Winnipeg Manitoba

More University of Manitoba trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04750200 on ClinicalTrials.gov ↗ ← All trials in Canada