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Comparing embolization and surgery for chronic subdural hematoma treatment

Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

NA · The University of Texas Medical Branch, Galveston · NCT06347796

This study is testing if a new procedure called middle meningeal artery embolization can be a safer and more effective option than traditional surgery for people with chronic subdural hematomas.

Quick facts

PhaseNA
Study typeInterventional
Enrollment520 (estimated)
Ages40 Years to 90 Years
SexAll
SponsorThe University of Texas Medical Branch, Galveston (other)
Locations31 sites (Phoenix, Arizona and 30 other locations)
Trial IDNCT06347796 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of middle meningeal artery embolization (MMAE) as an alternative to conventional open surgery for patients with moderately symptomatic chronic subdural hematoma (CSDH). Participants will undergo medical assessments, including CT scans and questionnaires, and will be randomized to receive either MMAE or surgery. The study will compare outcomes between the two groups, focusing on the need for rescue surgery and safety profiles. The goal is to determine if MMAE can reduce complications and improve patient outcomes compared to traditional surgical methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-90 with specific types of chronic subdural hematoma as confirmed by CT scans.

Not a fit: Patients with secondary causes of subdural hematoma or those who have previously undergone craniotomy for this condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with chronic subdural hematoma.

How similar studies have performed: While the use of MMAE is a novel approach in this context, similar studies have shown promise in other conditions, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 and the contralateral side is asymptomatic and \< 5 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. 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.

Where this trial is running

Phoenix, Arizona and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Subdural Hematoma, chronic subdural hematoma, middle meningeal artery embolization

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.