Improving the Outcome of Chronic Subdural Hematoma by Embolization of Middle Meningeal Artery (ELIMINATE)

What this Trial Is About

Chronic subdural hematoma (cSDH) is a common brain condition especially affecting frail and elderly patients, characterized by bleeding between the dura mater and arachnoid. Surgery using burr hole craniostomy is the standard treatment but has a recurrence rate of 10-30%, which often leads to reoperations that are risky in this vulnerable group. Researchers are evaluating whether adding embolization of the middle meningeal artery after surgery can reduce the need for repeat surgery and improve outcomes in patients with symptomatic cSDH. In this multicenter randomized controlled trial, patients diagnosed with symptomatic cSDH requiring surgery are divided into two groups. One group receives standard surgical evacuation alone, while the other group receives embolization of the middle meningeal artery within 72 hours after surgery. The embolization procedure involves local anesthesia and catheter-based delivery of particles to block blood flow in the artery. Follow-up includes outpatient visits at 8, 16, and 24 weeks with CT scans and clinical assessments. Participants will be monitored during hospital admission and follow-up visits for complications and recovery. Assessments include neurological scales (mRS, mNIHSS, Markwalder score), cognitive testing (MOCA), quality of life questionnaires (SF-36, EQ-5D-5L), disability scores (ALDS), and health economic questionnaires (iMCQ, iPCQ). The main outcome is the number of patients needing repeat surgery within 24 weeks. The study also tracks changes in hematoma size, mortality, neurological impairment, and healthcare use over this period.

Embolization of Middle Meningeal Artery in Chronic Subdural Hematoma