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Brain bleed breakthrough? new procedure aims to stop clots from returning

NCT ID NCT04750200

Disease control Sponsor: University of Manitoba Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether blocking a specific artery in the brain (middle meningeal artery embolization) can lower the chance of a chronic subdural hematoma coming back after standard surgical drainage. About 192 adults with a large, symptomatic hematoma will be randomly assigned to get surgery alone or surgery plus the artery-blocking procedure. The main goal is to see if the hematoma returns within 90 days.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

192 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural, Chronic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic subdural hematoma

Contacts and locations

Locations

  • University of Manitoba

    Winnipeg, Manitoba, R3E 3P5, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.