Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 90
Healthy Volunteers: f
View:

• Age 40-90 years inclusively.

• 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.

• CSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying CSDH.

• Qualifying baseline head CT performed within the 7 days prior to randomization.

• Able to undergo assigned treatment within 72 hours after randomization.

• Patient or legally authorized representative agrees to be randomized, and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Locations
United States
Arizona
Mayo Clinic Arizona
RECRUITING
Phoenix
Florida
Baptist Medical Center Jacksonville
RECRUITING
Jacksonville
University of Miami Miller School of Medicine
RECRUITING
Miami
University of South Florida
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Illinois
University of Illinois
RECRUITING
Chicago
North Shore University Health System
RECRUITING
Evanston
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Missouri
University of Missouri Healthcare
RECRUITING
Columbia
Washington University, St. Louis
RECRUITING
St Louis
North Carolina
Wake Forest University
RECRUITING
Winston-salem
New Jersey
Cooper University Hospital
RECRUITING
Camden
JFK Neuroscience Institute, JFK University Medical Center
NOT_YET_RECRUITING
Edison
Rutgers, The State University of New Jersey
RECRUITING
Newark
New York
Ichan School of Medicine at Mount Sinai
RECRUITING
New York
SUNY Upstate Medical University
RECRUITING
Syracuse
Montefiore Medical Center
NOT_YET_RECRUITING
The Bronx
Westchester Medical Center
RECRUITING
Valhalla
Ohio
Good Samaritan Hospital
RECRUITING
Cincinnati
Pennsylvania
University of Pennyslvania
RECRUITING
Philadelphia
Philadelphia Neurological Institute
NOT_YET_RECRUITING
Upland
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
University of Texas Medical Branch
RECRUITING
Galveston
University of Texas Health Science Center-Houston
RECRUITING
Houston
University of Texas Health Science Center-San Antonio
RECRUITING
San Antonio
Utah
University of Utah
RECRUITING
Salt Lake City
Virginia
University of Virginia
NOT_YET_RECRUITING
Charlottesville
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Jessica Spahn
jlspahn@utmb.edu
409-266-8859
Backup
Roberto Garcia
robgarci@utmb.edu
409-772-3182
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2029-02
Participants
Target number of participants: 520
Treatments
Experimental: Middle Menningeal Artery Embolization (MMAE)
Active_comparator: Conventional Surgery (Craniotomy or Burr Holes)
Sponsors
Leads: The University of Texas Medical Branch, Galveston
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov