Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study (CHESS)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Device: Middle Meningeal Artery Embolization (MMAE); Procedure: Conventional Surgery

• Study Type: Interventional
• Enrollment (Estimated): 520
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberto Garcia; Phone Number: 409-772-3182; Email: robgarci@utmb.edu
• Study Contact Backup: Name: Jessica Spahn; Phone Number: 409-266-8859; Email: jlspahn@utmb.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Arizona
      • Principal Investigator: Bernard Bendok, MD
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist Medical Center Jacksonville
      • Principal Investigator: Ricardo Hanel, MD
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Miller School of Medicine
      • Principal Investigator: Robert Starke, MD
    • Tampa, Florida, United States, 33617
      • Recruiting
      • University Of South Florida
      • Principal Investigator: Maxim Mokin, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Principal Investigator: Jonathan Grossberg
  • Kansas
    • Kansas City, Kansas, United States, 61660
      • Recruiting
      • University of Kansas Medical Center
      • Principal Investigator: Koji Ebersole, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Principal Investigator: Nirav Patel, MD
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Christopher Stapleton, MD
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Principal Investigator: Philip Taussky, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Withdrawn
      • University of Minnesota
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • University of Missouri Healthcare
      • Contact: Brooke Hoffman
      • Principal Investigator: Steven Carr
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University, St. Louis
      • Principal Investigator: Joshua Osbun, MD
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper University Hospital
      • Contact: Sean Behnke
      • Principal Investigator: Daniel Tonetti, MD
    • Edison, New Jersey, United States, 08820
      • Recruiting
      • JFK Neuroscience Institute, JFK University Medical Center
      • Principal Investigator: Brian Jankowitz, MD
    • Newark, New Jersey, United States, 07101
      • Recruiting
      • Rutgers, The State University of New Jersey
      • Principal Investigator: Amit Singla, MD
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Ichan School of Medicine at Mount Sinai
      • Principal Investigator: Christopher Kellner, MD
    • Syracuse, New York, United States, 13210
      • Active, not recruiting
      • SUNY Upstate Medical University
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Principal Investigator: David Altschul, MD
    • Valhalla, New York, United States, 10595
      • Recruiting
      • Westchester Medical Center
      • Principal Investigator: Chirag Gandhi, MD
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University
      • Principal Investigator: Stacey Wolfe, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Recruiting
      • Good Samaritan Hospital
      • Principal Investigator: Andrew Ringer, MD
    • Toledo, Ohio, United States, 43608
      • Not yet recruiting
      • Mercy Health St. Vincent Medical Center
      • Principal Investigator: Osama Zaidat, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennyslvania
      • Principal Investigator: Jan Burkhardt, MD
    • Upland, Pennsylvania, United States, 19013
      • Recruiting
      • Philadelphia Neurological Institute
      • Principal Investigator: Mandy Binning, MD
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT southwestern Medical Center
      • Principal Investigator: Babu Welch, MD
    • Galveston, Texas, United States, 77555
      • Recruiting
      • University of Texas Medical Branch
      • Principal Investigator: Peter Kan, MD
      • Contact: Jessica L Spahn; Phone Number: 409-266-8859; Email: jlspahn@utmb.edu
      • Contact: Lauren Dawson; Phone Number: 409-354-9792; Email: lndawson@utmb.edu
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas Health Science Center-Houston
      • Principal Investigator: Sunil Sheth, MD
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center-San Antonio
      • Principal Investigator: Justin Mascitelli, MD
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah
      • Principal Investigator: Ramesh Grandhi, MD
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Principal Investigator: Andrew Carlson, MD
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • University of Washington
      • Principal Investigator: Michael Levitt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 40-90 years inclusively.
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 (at least 10 mm in thickness) and the contralateral side is asymptomatic and < 10 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:

1. Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor.
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. For unilateral CSDH, 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.
25. For bilateral CSDH, no measurable deficit secondary to the treatment-eligible CSDH on the ASR or MRC. 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 treatment-eligibile CSDH side.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Middle Menningeal Artery Embolization (MMAE)	Device: Middle Meningeal Artery Embolization (MMAE); Particle embolization of the middle meningeal artery with micron variants of the Embosphere Microspheres or CONTOUR Embolization Particles device.
Active Comparator: Conventional Surgery (Craniotomy or Burr Holes)	Procedure: Conventional Surgery; Conventional surgery is surgical drainage through burr holes or craniotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for Rescue Surgery or Death	Participants who need rescue surgery or die.	Within 180-210 days of randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of MMAE and Conventional Open Surgery	The proportion of subjects with symptomatic ischemic stroke, serious/life threatening adverse events, worsening of neurological status (a decline of 1 point on the Markwalder scale) or development of new disabling neurological symptoms, seizures, and/or cranial neuropathy.	Within 180 days of randomization.

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: chronic subdural hematoma (CSDH); middle meningeal artery embolization (MMAE)
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Pathological Conditions, Signs and Symptoms; Hematoma, Subdural; Hematoma; Hematoma, Subdural, Chronic
• Other Study ID Numbers: 23-0160; UG3NS128397 (U.S. NIH Grant/Contract); UH3NS128397 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes