Actively Recruiting
Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
Led by The University of Texas Medical Branch, Galveston · Updated on 2026-05-22
520
Participants Needed
31
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The University of Texas Medical Branch, Galveston
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates whether middle meningeal artery embolization (MMAE) can be a safe and effective alternative to conventional open surgery for patients with moderately symptomatic chronic subdural hematoma (CSDH). The study aims to determine if MMAE reduces the need for additional rescue surgery or deaths compared to standard surgery and to assess the safety of both treatments in this patient group. Participants will be randomly assigned to receive either MMAE, which involves particle embolization of the middle meningeal artery using specialized devices, or conventional surgery through burr holes or craniotomy to drain the hematoma. Treatments are delivered soon after randomization, and participants in both groups are monitored closely for outcomes. During the study, participants will share medical history, undergo physical exams, blood tests, and head CT scans. They will also complete questionnaires and report any adverse events. Researchers will follow participants for about 180 to 210 days after treatment to measure the need for rescue surgery or death and evaluate treatment safety. This process includes regular evaluations to track progress and health status.
CONDITIONS
Brief Title
Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 to 90 years inclusive
- Unilateral convexity chronic subdural hematoma (CSDH) at least 10 mm thick on CT scan or bilateral CSDH if only one side is treated and the other side is asymptomatic and less than 10 mm thick
- CSDH is at least two-thirds isodense or hypodense on CT
- Baseline head CT done within 7 days before randomization
- Able to undergo assigned treatment within 72 hours after randomization
- Patient or authorized representative agrees to randomization and provides informed consent and HIPAA authorization
You will not qualify if you...
- Subdural hematoma caused by other reasons than trauma, such as vascular abnormality or tumor
- Tentorial or interhemispheric subdural hematoma
- Muscle weakness on the opposite side of the CSDH as defined by MRC scores 0-3
- Modified Rankin Scale (mRS) score of 5 or higher before CSDH
- Unable to complete Timed Up and Go test (TUG) within 120 seconds due to CSDH
- Aphasia Severity Rating (ASR) score of 0-2
- Immediate need for surgical evacuation like craniotomy, burr hole drainage, or Subdural Evacuating Port System
- Cannot stop antiplatelet or oral anticoagulant medication for 7 days after randomization
- Plan to withdraw care for the CSDH
- Surgical treatment for CSDH less than 30 days before randomization
- Use of tranexamic acid
- Low platelet count (<100,000 per microliter) not corrected by transfusion
- Uncorrected coagulopathy with INR above 1.5
- Known contraindications to angiography or intolerance to occlusion procedures
- Blood vessel anatomy or flow problems preventing catheter placement or embolization
- Presence of collateral vessels risking normal brain areas during embolization
- Large arteriovenous shunts or direct artery-to-vein blood flow not treatable with coil embolization
- Active systemic infection or sepsis
- Pregnancy, planning pregnancy, or breastfeeding
- Life expectancy under 6 months due to other serious illnesses
- Participation in another experimental therapy study
- Unable or unlikely to comply with study protocol
- No measurable deficits on TUG, ASR, or MRC related to CSDH for unilateral or bilateral CSDH as defined by specific scores
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 72 hours after randomization
Participants undergo treatment with either middle meningeal artery embolization or conventional surgery for chronic subdural hematoma.
1 treatment visit (in-person)
Duration - 180 to 210 days
Participants are monitored for safety and need for rescue surgery or death for up to 180 to 210 days after randomization.
Periodic visits during follow-up
Trial Site Locations
Total: 31 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
3
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
4
University of South Florida
Tampa, Florida, United States, 33617
Actively Recruiting
5
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
University of Kansas Medical Center
Kansas City, Kansas, United States, 61660
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
9
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Withdrawn
11
University of Missouri Healthcare
Columbia, Missouri, United States, 65212
Actively Recruiting
12
Washington University, St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
13
Cooper University Hospital
Camden, New Jersey, United States, 08103
Actively Recruiting
14
JFK Neuroscience Institute, JFK University Medical Center
Edison, New Jersey, United States, 08820
Actively Recruiting
15
Rutgers, The State University of New Jersey
Newark, New Jersey, United States, 07101
Actively Recruiting
16
Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
17
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Active, Not Recruiting
18
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
19
Westchester Medical Center
Valhalla, New York, United States, 10595
Actively Recruiting
20
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
21
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Actively Recruiting
22
Mercy Health St. Vincent Medical Center
Toledo, Ohio, United States, 43608
Not Yet Recruiting
23
University of Pennyslvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
24
Philadelphia Neurological Institute
Upland, Pennsylvania, United States, 19013
Actively Recruiting
25
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
26
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Actively Recruiting
27
University of Texas Health Science Center-Houston
Houston, Texas, United States, 77030
Actively Recruiting
28
University of Texas Health Science Center-San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
29
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
30
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
31
University of Washington
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
J
Jessica Spahn
R
Roberto Garcia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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