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Coil Embolization for Chronic Subdural Hematomas

This study is looking at two ways to treat chronic subdural hematomas (cSDH), which are collections of blood on the brain's surface. Researchers want to see if blocking blood flow to the hematoma using coils in one artery (unilateral embolization therapy) is as effective as blocking it in two arteries (bilateral embolization therapy). You could be eligible if you are 18 or older, have a chronic subdural hematoma causing symptoms, and have a modified Rankin Score (mRS) of 3 or less, which measures your level of disability. The main goal is to see how much the hematoma shrinks over 1 to 3 months. The current status of this study is unclear.

Study design
This is a randomized controlled trial involving up to 400 participants. You would be randomly assigned to receive either unilateral or bilateral embolization therapy.
What's involved
You would undergo either a unilateral or bilateral embolization procedure. Your hematoma size and functional outcomes will be checked at baseline, 1 month, and 3 months after the procedure.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 3 months after the treatment to assess changes in hematoma thickness.

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NCT07715656

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

Recruiting
NAAges 18+InterventionalTreatment
Lahey Clinic
~400 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:embolization therapy Bilateralembolization therapy Unilateral

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in cSDH Maximum thickness From Baseline on Non-contrast Head CT
Measured over Baseline, 1 month (3-6 weeks), and 3 months (10-14 weeks)

Conditions

Chronic Subdural Hematoma

Explore related trials

Chronic intracranial subdural hematoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Jonathan Pace, MD · PRINCIPAL_INVESTIGATOR · Lahey Hospital & Medical Center

Who to contact

Sandy L Alvarez, MD
[email protected]
7865800186
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Midline shift \< 10mm and hematoma thickness \> 10 mm as measured on coronal imaging perpendicular to the skull.
No focal deficit related to the chronic subdural hematoma requiring surgical intervention

Exclusion

Candidates will be excluded from participation if ANY of the following apply:

What this trial measures

  • Change in cSDH Maximum thickness From Baseline on Non-contrast Head CTBaseline, 1 month (3-6 weeks), and 3 months (10-14 weeks)

    Change in maximum hematoma thickness (mm) and Volume (mL) measured on non-contrast head CT compared with baseline. Measurements will be performed using standardized imaging review.