Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

Eligibility 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.
• 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.