Management of CSDH With or Without EMMA- a Randomized Control Trial (NCT04750200) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Chronic Subdural Hematoma (CSDH) recurrence at 90-days on CT scan
. 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;