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NCT06347796NARecruiting

Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

The University of Texas Medical Branch, Galveston

Start Date

11/1/2024

Completion Date

2/1/2029

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 Criteria

Age Range: 40 years to 90 years

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.

Interventions

PROCEDURE

Conventional Surgery

DEVICE

Middle Meningeal Artery Embolization (MMAE)

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Conditions

Chronic Subdural Hematoma

Locations

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