Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
CHESS
3 other identifiers
interventional
520
1 country
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
Longer than P75 for not_applicable
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2024
CompletedFirst Posted
Study publicly available on registry
April 4, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
March 12, 2026
March 1, 2026
4.3 years
March 22, 2024
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Need for Rescue Surgery or Death
Participants who need rescue surgery or die.
Within 180-210 days of randomization
Secondary Outcomes (1)
Safety of MMAE and Conventional Open Surgery
Within 180 days of randomization.
Study Arms (2)
Middle Menningeal Artery Embolization (MMAE)
EXPERIMENTALConventional Surgery (Craniotomy or Burr Holes)
ACTIVE COMPARATORInterventions
Conventional surgery is surgical drainage through burr holes or craniotomy.
Particle embolization of the middle meningeal artery with micron variants of the Embosphere Microspheres or CONTOUR Embolization Particles device.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor.
- Tentorial or interhemispheric SDH.
- Secondary to CSDH, MRC of 0, 1, 2, or 3 in any muscle group contralateral to the side of the CSDH 4.
- Pre CSDH mRS of 5 or higher.
- 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.
- Secondary to CSDH, ASR of 0, 1, or 2.
- Emergent surgical evacuation such as open craniotomy, burr hole drainage, or Subdural Evacuating Port System (SEPS) is required for the patient.
- Unable to withhold all antiplatelet agents or OACs for the first 7 days after randomization.
- Indication that withdrawal of care will be implemented for the qualifying SDH.
- Prior surgical treatment for CSDH if the surgery is less than 30 days prior to randomization.
- On tranexamic acid.
- Platelet count of \<100,000 per microliter refractory to transfusion.
- Coagulopathy that cannot be corrected to an INR of ≤1.5.
- Known contraindications to angiography.
- Known intolerance to occlusion procedures.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, 32207, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
University of South Florida
Tampa, Florida, 33617, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Kansas Medical Center
Kansas City, Kansas, 61660, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Missouri Healthcare
Columbia, Missouri, 65212, United States
Washington University, St. Louis
St Louis, Missouri, 63110, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
JFK Neuroscience Institute, JFK University Medical Center
Edison, New Jersey, 08820, United States
Rutgers, The State University of New Jersey
Newark, New Jersey, 07101, United States
Ichan School of Medicine at Mount Sinai
New York, New York, 10029, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, 43608, United States
University of Pennyslvania
Philadelphia, Pennsylvania, 19104, United States
Philadelphia Neurological Institute
Upland, Pennsylvania, 19013, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
University of Texas Health Science Center-Houston
Houston, Texas, 77030, United States
University of Texas Health Science Center-San Antonio
San Antonio, Texas, 78229, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
University of Washington
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2024
First Posted
April 4, 2024
Study Start
November 1, 2024
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
February 1, 2029
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share