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

ConditionChronic Subdural Hematoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLahey Clinic

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is 18 years of age or older.

Subject has a diagnosis of chronic subdural hematoma with mass effect Determined by brain imaging (CT or MRI) and correlated clinical symptoms.

Pre-randomization modified Rankin Score (mRS) ≤3

Subdural Hematoma Size

Disqualifiers

Patients presenting with an acute SDH (e.g. patient with presenting with a SDH due to trauma); mixed density is permitted.

Subject presents with bilateral cSDHs requiring treatment (contralateral cSDH <5mm and not requiring treatment is permitted.

Subject presents with Glasgow Coma Scale < 9

Markwalder assessment >4

Trial design

Design model

Parallel

Treatments tested in this trial

  • embolization therapy Bilateral

    Device

    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.

  • embolization therapy Unilateral

    Device

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Medical ManagementActive comparator 2 interventions
Group B: SurgicalActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in cSDH Maximum thickness From Baseline on Non-contrast Head CT

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.

Time frame
Baseline, 1 month (3-6 weeks), and 3 months (10-14 weeks)

Secondary outcomes

1

Number of Participants Requiring Additional surgical Intervention

Number of participants requiring additional surgical treatment after randomization, including initial surgical evacuation in the medical management cohort or repeat hematoma evacuation in the surgical cohort.

Time frame
Through 3 months
2

Change from Baseline in Modified Rankin scale (mRS) Score

Functional outcome measured using the Modified Rankin Scale (range 0-6). change from baseline will be reported.

Time frame
Baseline, 1 month, and 3 months
3

Number of participants with Procedure-related Serious Adverse Events

Number of participants experiencing procedure related adverse events, including but not limited to ischemic stroke, intracranial hemorrhage, arterial dissection, vessel perforation, access-site complications requiring intervention, or death.

Time frame
through 3 months after embolization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lahey Clinic

Lead sponsor

Source ClinicalTrials.gov
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