Active — Not RecruitingNot Applicable

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

Canada192 participantsStarted 2021-08-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

Chronic Subdural Hematoma (CSDH) recurrence at 90-days on CT scan

Timeframe: 90-days

Trial details

NCT IDNCT04750200

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

View on ClinicalTrials.gov More Chronic Subdural Hematoma trials