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Compares treatment options for Chronic Subdural Hematoma
Official title Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas
ClinicalTrials.gov ID: NCT07715656
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Candidates for this study must meet ALL of the following criteria:
- 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 a. Surgical Cohort: Assessment should reflect the subject's condition just prior to undergoing...
- Subdural Hematoma Size Medical Management Cohort:
You likely can't join if
- Candidates will be excluded from participation if ANY of the following apply:
- 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
- cSDH that developed with underlying conditions such as vascular lesions, brain tumor, arachnoid cyst, spontaneous intracranial hypotension, end stage...
See the full eligibility criteria
- Candidates for this study must meet ALL of the following criteria:
- 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 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.
- Subdural Hematoma Size Medical Management Cohort:
- Midline shift \ 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
- 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...
- Patient or designated Legal Authorized Representative, confirms the patient has the mental capacity, willingness and ability to comply with protocol and follow-up requirements
- 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.
- Candidates will be excluded from participation if ANY of the following apply:
- 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
- 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...
- Prior carotid stent placement that crosses the origin of the External Carotid Artery (ECA) ipsilateral to the subdural hematoma
- Presumed septic embolus, or suspicion of microbial superinfection
- CT or MRI evidence of intra-cranial tumor or mass lesion
- Significant contraindication to angiography (eg. kidney failure).
- Life expectancy of less than 1-year
- 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...
- Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. people in observational, natural history, and/or epidemiological studies not involving intervention are...
- Patient unwilling to follow SOC recommendations (e.g. refuses surgery or lifestyle modifications)
The study team makes the final eligibility decision.
Where it's taking place
- Burlington, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Burlington, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.