Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

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.