Actively Recruiting
Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
Led by The University of Texas Medical Branch, Galveston · Updated on 2026-03-12
520
Participants Needed
31
Research Sites
221 weeks
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
The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are: * 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.
CONDITIONS
Official Title
Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 90 years inclusive
- Unilateral convexity chronic subdural hematoma (CSDH) at least 10 mm thick on head CT OR bilateral CSDH with only one side treated and the other side asymptomatic and less than 5 mm thick
- CSDH is at least two-thirds isodense or hypodense on axial CT slice
- Baseline qualifying head CT performed within 7 days before randomization
- Able to undergo assigned treatment within 72 hours after randomization
- Patient or authorized representative agrees to randomization and provides written informed consent and HIPAA authorization
You will not qualify if you...
- Secondary cause of subdural hematoma other than trauma, such as vascular abnormality or tumor
- Tentorial or interhemispheric subdural hematoma
- Muscle strength rating of 0 to 3 in any muscle group opposite the side of the chronic subdural hematoma
- Modified Rankin Scale score of 5 or higher before CSDH
- Unable to complete Timed Up and Go (TUG) test due to CSDH (taking more than 120 seconds, unable to walk, or quitting the test early)
- Aphasia Severity Rating (ASR) of 0 to 2
- Emergent surgical evacuation required (open craniotomy, burr hole drainage, or Subdural Evacuating Port System)
- Unable to stop all antiplatelet agents or oral anticoagulants for 7 days after randomization
- Indication that withdrawal of care will be implemented for the qualifying subdural hematoma
- Prior surgical treatment for CSDH within 30 days before randomization
- Currently taking tranexamic acid
- Platelet count below 100,000 per microliter that does not respond to transfusion
- Coagulopathy that cannot be corrected to an INR of 1.5 or less
- Known contraindications to angiography or intolerance to occlusion procedures
- Vascular anatomy or blood flow preventing catheter placement or embolic agent injection
- Presence of collateral vessel pathways risking normal brain areas during embolization
- Large diameter arteriovenous shunt or patent extracranial to intracranial anastomoses that cannot be treated with coil embolization
- Active systemic infection or sepsis
- Pregnant, planning pregnancy, or lactating
- Life expectancy less than 6 months due to other terminal conditions
- Participation in another research study for experimental therapy
- Unable or suspected to be unable to comply with the study protocol
- No measurable deficit related to the chronic subdural hematoma on functional tests at baseline (Timed Up and Go, Aphasia Severity Rating, or muscle strength)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not Yet 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
CONTACT
R
Roberto Garcia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here