Coil treatment showdown: one side or both for brain bleed?
NCT ID NCT07715656
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This trial tests whether blocking the blood supply to a chronic subdural hematoma (a slow brain bleed) on one side or both sides works better. Adults with a unilateral hematoma will receive either unilateral or bilateral coil embolization. The study measures changes in hematoma size and the need for additional surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- coil embolization of the middle meningeal artery
- What this could lead to
- If successful, this could establish a standard approach for treating chronic subdural hematomas with fewer repeat surgeries.
- What could go wrong
- This is a mid-sized trial comparing two techniques; results may not show a clear advantage, and risks like bleeding or stroke remain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 thickness \> 10 mm as measured on coronal imaging perpendicular to the skull. * No focal deficit related to the chronic subdural hematoma requiring surgical intervention Surgical Cohort: • No requirement 5. A CT performed prior to randomization demonstrating stability of the hematoma. Stability is defined as no worsening of midline shift or increase in the size of the cSDH from the screening image that results in new or worsening clinical symptoms. 6. Patient or designated Legal Authorized Representative, confirms the patient has the mental capacity, willingness and ability to comply with protocol and follow-up requirements 7. In the opinion of the treating physician, MMA embolization is technically feasible, including evaluation of preoperative CTA, if available, or presence of a foramen spinosum bilaterally. Exclusion Criteria: * Candidates will be excluded from participation if ANY of the following apply: 1. Patients presenting with an acute SDH (e.g. patient with presenting with a SDH due to trauma); mixed density is permitted. 2. Subject presents with bilateral cSDHs requiring treatment (contralateral cSDH \<5mm and not requiring treatment is permitted. 3. Subject presents with Glasgow Coma Scale \< 9 4. Markwalder assessment \>4 5. cSDH that developed with underlying conditions such as vascular lesions, brain tumor, arachnoid cyst, spontaneous intracranial hypotension, end stage renal disease (ESRD) on hemodialysis, end stage liver disease or other comorbidities causing a coagulopathy 6. Prior carotid stent placement that crosses the origin of the External Carotid Artery (ECA) ipsilateral to the subdural hematoma 7. Presumed septic embolus, or suspicion of microbial superinfection 8. CT or MRI evidence of intra-cranial tumor or mass lesion 9. Significant contraindication to angiography (eg. kidney failure). 10. Life expectancy of less than 1-year 11. Women who are pregnant, lactating, plan on becoming pregnant during the course of the clinical investigation. We routinely do pregnancy tests prior to this procedure, to avoid radiation exposure to the fetus including radiation on follow up CT scans 12. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Subjects in observational, natural history, and/or epidemiological studies not involving intervention are eligible 13. Patient unwilling to follow SOC recommendations (e.g. refuses surgery or lifestyle modifications)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lahey Hospital & Medical Center
RECRUITINGBurlington, Massachusetts, 01803, United States
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