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New hope for brain bleed patients: could a simple embolization replace surgery?

NCT ID NCT06347796

Disease control Sponsor: The University of Texas Medical Branch, Galveston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares a minimally invasive procedure called middle meningeal artery embolization (MMAE) to standard open surgery for treating chronic subdural hematoma, a type of brain bleed. About 520 moderately symptomatic adults aged 40-90 will be randomly assigned to one of the two treatments. The main goal is to see if MMAE reduces the need for additional rescue surgery or death, while also checking its safety.

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

About 520 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Feb 2029

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

40 to 90 years

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. Age 40-90 years inclusively. 2. Per CT of the head, (one of the following): Unilateral convexity CSDH measuring at least 10 mm in thickness OR Bilateral CSDH if only one side is considered for treatment (at least 10 mm in thickness) and the contralateral side is asymptomatic and \< 10 mm in thickness. 3. CSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying CSDH. 4. Qualifying baseline head CT performed within the 7 days prior to randomization. 5. Able to undergo assigned treatment within 72 hours after randomization. 6. Patient or legally authorized representative agrees to be randomized, and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization. Exclusion Criteria: 1. Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor. 2. Tentorial or interhemispheric SDH. 3. Secondary to CSDH, MRC of 0, 1, 2, or 3 in any muscle group contralateral to the side of the CSDH 4. 4. Pre CSDH mRS of 5 or higher. 5. Secondary to CSDH, patient is unable to complete TUG (i.e.,TUG \> 120 seconds, unable to walk, or tries TUG but quits in ≤ 120 seconds). Note: This criterion does not apply if the patient does not complete TUG for reason other than CSDH. 6. Secondary to CSDH, ASR of 0, 1, or 2. 7. Emergent surgical evacuation such as open craniotomy, burr hole drainage, or Subdural Evacuating Port System (SEPS) is required for the patient. 8. Unable to withhold all antiplatelet agents or OACs for the first 7 days after randomization. 9. Indication that withdrawal of care will be implemented for the qualifying SDH. 10. Prior surgical treatment for CSDH if the surgery is less than 30 days prior to randomization. 11. On tranexamic acid. 12. Platelet count of \<100,000 per microliter refractory to transfusion. 13. Coagulopathy that cannot be corrected to an INR of ≤1.5. 14. Known contraindications to angiography. 15. Known intolerance to occlusion procedures. 16. Known vascular anatomy (small artery size) or blood flow (high vascular resistance peripheral to the feeding arteries) that precludes catheter placement or embolic agent (Embosphere Microspheres or CONTOUR particles) injection. 17. Known presence of collateral vessel pathways potentially endangering normal territories or cranial nerves during embolization. 18. Known large diameter arteriovenous shunt, i.e., where the blood does not pass through an arterial/capillary/venous transition but directly from an artery to a vein or presence of patent extra-to-intracranial anastomoses (where study embolization devices could pass directly into the internal carotid artery, vertebral artery, or intracranial vasculature) that cannot be addressed with coil embolization. 19. Patient has a known active systemic infection or sepsis. 20. Patient is pregnant, planning to become pregnant, or lactating. 21. Life expectancy of less than 6 months due to comorbid terminal conditions. 22. Concurrent participation in another research protocol for investigation of an experimental therapy. 23. Known or suspected to not be able to comply with the study protocol. 24. For unilateral CSDH, no measurable deficit secondary to the CSDH on the Timed Up and Go \[TUG\], Aphasia Severity Rating \[ASR\], or MRC. At baseline, a measurable deficit on the TUG is defined as: time ≥10 seconds. At baseline, a measurable deficit on the ASR is defined as: a score ≤4. At baseline, a measurable deficit on the MRC is defined as: a score \< 5 in any muscle group contralateral to the site of the CSDH. 25. For bilateral CSDH, no measurable deficit secondary to the treatment-eligible CSDH on the ASR or MRC. At baseline, a measurable deficit on the ASR is defined as: a score ≤4. At baseline, a measurable deficit on the MRC is defined as: a score \< 5 in any muscle group contralateral to the treatment-eligibile CSDH side.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baptist Medical Center Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cooper University Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Good Samaritan Hospital

    RECRUITING

    Cincinnati, Ohio, 45220, United States

  • Ichan School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • JFK Neuroscience Institute, JFK University Medical Center

    RECRUITING

    Edison, New Jersey, 08820, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mercy Health St. Vincent Medical Center

    NOT_YET_RECRUITING

    Toledo, Ohio, 43608, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Philadelphia Neurological Institute

    RECRUITING

    Upland, Pennsylvania, 19013, United States

  • Rutgers, The State University of New Jersey

    RECRUITING

    Newark, New Jersey, 07101, United States

  • SUNY Upstate Medical University

    ACTIVE_NOT_RECRUITING

    Syracuse, New York, 13210, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 61660, United States

  • University of Miami Miller School of Medicine

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Minnesota

    WITHDRAWN

    Minneapolis, Minnesota, 55455, United States

  • University of Missouri Healthcare

    RECRUITING

    Columbia, Missouri, 65212, United States

  • University of Pennyslvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33617, United States

  • University of Texas Health Science Center-Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Texas Health Science Center-San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Texas Medical Branch

    RECRUITING

    Galveston, Texas, 77555, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98104, United States

  • Wake Forest University

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University, St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Westchester Medical Center

    RECRUITING

    Valhalla, New York, 10595, United States

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