Randomized Controlled Trial Comparing Unilateral and Bilateral Coil Embolization for Treatment of Chronic Subdural Hematomas

What this Trial Is About

Researchers are conducting a prospective, multicenter, randomized controlled trial to evaluate the treatment of unilateral chronic subdural hematomas cSDH using coil embolization of the middle meningeal artery MMA. The study compares unilateral versus bilateral MMA embolization in patients with cSDH and aims to assess the impact on hematoma size and patient functional outcomes over a follow-up period of 1 to 3 months. Participants will be randomly assigned to receive either unilateral embolization of the MMA on the side of the hematoma or bilateral embolization of both MMAs regardless of hematoma location. Two cohorts exist one undergoing embolization as part of medical management, and another receiving embolization in addition to standard surgical treatment. Imaging guidance, including pre- and post-procedure scans, is used to ensure accurate coil placement and vessel occlusion. During the study, participants will have baseline assessments and follow-up evaluations including non-contrast head CT scans at baseline, 1 month, and 3 months to measure changes in hematoma thickness. Functional status will be assessed using the modified Rankin scale at the same intervals. Researchers will monitor the need for additional surgical interventions and record any procedure-related serious adverse events. The total participation duration is up to 3 months, with monitoring focused on treatment effects and safety.

Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas