Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

Launched by THE UNIVERSITY OF TEXAS MEDICAL BRANCH, GALVESTON · Mar 29, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients with chronic subdural hematoma (CSDH), a condition where blood collects on the brain's surface, usually due to previous head injuries. The study is comparing a procedure called middle meningeal artery embolization (MMAE) with traditional open surgery to see if MMAE could be a safer and more effective alternative. Researchers want to find out if MMAE reduces the need for further surgeries or deaths compared to surgery and assess how safe both treatments are.

To participate, individuals must be between 40 and 90 years old and have specific types of CSDH that meet the trial's criteria. Participants will undergo various assessments, including medical history reviews, blood tests, and CT scans. Depending on the random assignment, they will receive either the MMAE procedure or traditional surgery. Throughout the trial, participants will be monitored for any side effects or complications. This study is currently looking for volunteers, and their input could help determine the best way to treat this condition in the future.

Gender

ALL

Eligibility 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 48 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. Previous craniotomy for the treatment of CSDH if the craniotomy exceeds 7 cm at the maximal dimension on the baseline CT.
• • 4. mRS of 5 or higher.
• • 5. Emergent surgical evacuation such as open craniotomy, burr hole drainage, or Subdural Evacuating Port System (SEPS) is required for the patient.
• • 6. Unable to withhold all antiplatelet agents or OACs for the first 7 days after randomization.
• • 7. Indication that withdrawal of care will be implemented for the qualifying SDH.
• • 8. Prior surgical treatment for CSDH if the surgery is less than 30 days prior to randomization.
• • 9. On tranexamic acid.
• • 10. Platelet count of \<100,000 per microliter refractory to transfusion.
• • 11. Coagulopathy that cannot be corrected to an INR of ≤1.5.
• • 12. Known contraindications to angiography.
• • 13. Known intolerance to occlusion procedures.
• • 14. 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.
• • 15. Known presence of collateral vessel pathways potentially endangering normal territories or cranial nerves during embolization.
• • 16. 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.
• • 17. Patient has a known active systemic infection or sepsis.
• • 18. Patient is pregnant, planning to become pregnant, or lactating.
• • 19. Life expectancy of less than 6 months due to comorbid terminal conditions.
• • 20. Concurrent participation in another research protocol for investigation of an experimental therapy.
• • 21. Known or suspected to not be able to comply with the study protocol.
• • 22. No measurable deficit on the Timed Up and Go \[TUG\], Aphasia Severity Rating \[ASR\], or MRC.