RecruitingChronic Subdural Hematoma

Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

Eligible age

40–90 yrs

Accepts

All genders

Locations

16 states

Healthy volunteers

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About this study

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.

Sponsor: The University of Texas Medical Branch, Galveston

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.