Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
NCT ID: NCT06347796
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
520 participants
INTERVENTIONAL
2024-11-01
2029-02-28
Brief Summary
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* Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths?
* What is the safety of MMAE and conventional open surgery in these patients?
Participants will be asked to:
* Share their medical history and undergo physical examinations
* Have blood drawn
* Have CT scans of the head
* Answer questionnaires
* Undergo MMAE or conventional open surgery
* Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Middle Menningeal Artery Embolization (MMAE)
Middle Meningeal Artery Embolization (MMAE)
Particle embolization of the middle meningeal artery with micron variants of the Embosphere Microspheres or CONTOUR Embolization Particles device.
Conventional Surgery (Craniotomy or Burr Holes)
Conventional Surgery
Conventional surgery is surgical drainage through burr holes or craniotomy.
Interventions
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Conventional Surgery
Conventional surgery is surgical drainage through burr holes or craniotomy.
Middle Meningeal Artery Embolization (MMAE)
Particle embolization of the middle meningeal artery with micron variants of the Embosphere Microspheres or CONTOUR Embolization Particles device.
Eligibility Criteria
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Inclusion Criteria
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 and the contralateral side is asymptomatic and \< 5 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
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. 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.
40 Years
90 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Missouri Healthcare
Columbia, Missouri, United States
Washington University, St. Louis
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
JFK Neuroscience Institute, JFK University Medical Center
Edison, New Jersey, United States
Rutgers, The State University of New Jersey
Newark, New Jersey, United States
Ichan School of Medicine at Mount Sinai
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
University of Pennyslvania
Philadelphia, Pennsylvania, United States
Philadelphia Neurological Institute
Upland, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas Health Science Center-Houston
Houston, Texas, United States
University of Texas Health Science Center-San Antonio
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Brooke Hoffman
Role: primary
Sean Behnke
Role: primary
Other Identifiers
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