Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas: A Randomized Controlled Trial.
Lahey Clinic
Summary
This is a pragmatic, prospective, multicenter, randomized controlled trial with intention to treat analysis. In which subjects will receive either unilateral or bilateral middle meningeal artery (MMA) embolization using coils for the treatment of unilateral chronic subdural hematomas (cSDH).
Description
This study will enroll up to 400 subjects who will be randomized to receive either unilateral or bilateral coil MMA embolization. The study will assess the effect of the procedures on hematoma size and patient functional outcomes over 1 to 3 months of follow-up.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Candidates for this study must meet ALL of the following criteria: 1. Subject is 18 years of age or older. 2. Subject has a diagnosis of chronic subdural hematoma with mass effect Determined by brain imaging (CT or MRI) and correlated clinical symptoms. 3. Pre-randomization modified Rankin Score (mRS) ≤3 a. Surgical Cohort: Assessment should reflect the subject's condition just prior to undergoing surgery. Assessment may be performed post-surgery using pre-surgical data. 4. Subdural Hematoma Size Medical Management Cohort: * Midline shift \< 10mm and hematoma t…
Interventions
- Deviceembolization therapy Bilateral
In the bilateral approach, both middle meningeal arteries are accessed and embolized using coils, regardless of hematoma location. Imaging guidance is used throughout the procedure to ensure proper coil placement, and post-procedure imaging confirms that both vessels are fully occluded.
- Deviceembolization therapy Unilateral
In the unilateral approach, the middle meningeal artery (MMA) on the side of the hematoma is accessed via a catheter and occluded using coils under imaging guidance. The procedure targets only the affected side, and follow-up imaging is used to confirm successful embolization and vessel occlusion.
Location
- Lahey Hospital & Medical CenterBurlington, Massachusetts