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Compares treatment options for Chronic Subdural Hematoma
Official title Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
ClinicalTrials.gov ID: NCT06347796
What this study is testing
- What it's testing
- The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are: Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths?
- 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 40 to 90
You may be able to join if
- Age 40-90 years inclusively.
- Per CT of the head, (one of the following): Unilateral convexity CSDH measuring at least 10 mm in thickness OR Bilateral CSDH if only one side is...
- CSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying CSDH.
- Qualifying baseline head CT performed within the 7 days prior to randomization.
- Able to undergo assigned treatment within 72 hours after randomization.
You likely can't join if
- Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor.
- Tentorial or interhemispheric SDH.
- Secondary to CSDH, MRC of 0, 1, 2, or 3 in any muscle group contralateral to the side of the CSDH 4.
- Pre CSDH mRS of 5 or higher.
- Secondary to CSDH, patient is unable to complete TUG (i.e.,TUG \> 120 seconds, unable to walk, or tries TUG but quits in ≤ 120 seconds). Note: This...
- Secondary to CSDH, ASR of 0, 1, or 2.
See the full eligibility criteria
- Age 40-90 years inclusively.
- Per CT of the head, (one of the following): Unilateral convexity CSDH measuring at least 10 mm in thickness OR Bilateral CSDH if only one side is considered for treatment (at least 10 mm in thickness) and the...
- CSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying CSDH.
- Qualifying baseline head CT performed within the 7 days prior to randomization.
- Able to undergo assigned treatment within 72 hours after randomization.
- Patient or legally authorized representative agrees to be assigned by chance, and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor.
- Tentorial or interhemispheric SDH.
- Secondary to CSDH, MRC of 0, 1, 2, or 3 in any muscle group contralateral to the side of the CSDH 4.
- Pre CSDH mRS of 5 or higher.
- Secondary to CSDH, patient is unable to complete TUG (i.e.,TUG \> 120 seconds, unable to walk, or tries TUG but quits in ≤ 120 seconds). Note: This criterion does not apply if the patient does not complete TUG for...
- Secondary to CSDH, ASR of 0, 1, or 2.
- Emergent surgical evacuation such as open craniotomy, burr hole drainage, or Subdural Evacuating Port System (SEPS) is required for the patient.
- Unable to withhold all antiplatelet agents or OACs for the first 7 days after randomization.
- Indication that withdrawal of care will be implemented for the qualifying SDH.
- Prior surgical treatment for CSDH if the surgery is less than 30 days prior to randomization.
- On tranexamic acid.
- Platelet count of \<100,000 per microliter refractory to transfusion.
- Coagulopathy that cannot be corrected to an INR of ≤1.5.
- Known contraindications to angiography.
- Known intolerance to occlusion procedures.
- Known vascular anatomy (small artery size) or blood flow (high vascular resistance peripheral to the feeding arteries) that precludes catheter placement or embolic agent (Embosphere Microspheres or CONTOUR particles)...
- Known presence of collateral vessel pathways potentially endangering normal territories or cranial nerves during embolization.
- Known large diameter arteriovenous shunt, i.e., where the blood does not pass through an arterial/capillary/venous transition but directly from an artery to a vein or presence of patent extra-to-intracranial anastomoses...
- Patient has a known active systemic infection or sepsis.
- Patient is pregnant, planning to become pregnant, or lactating.
- Life expectancy of less than 6 months due to comorbid terminal conditions.
- Concurrent participation in another research protocol for investigation of an experimental therapy.
- Known or suspected to not be able to comply with the study protocol.
- For unilateral CSDH, no measurable deficit secondary to the CSDH on the Timed Up and Go [TUG], Aphasia Severity Rating [ASR], or MRC. At baseline, a measurable deficit on the TUG is defined as: time ≥10 seconds. At...
- For bilateral CSDH, no measurable deficit secondary to the treatment-eligible CSDH on the ASR or MRC. At baseline, a measurable deficit on the ASR is defined as: a score ≤4. At baseline, a measurable deficit on the MRC...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Columbia, Missouri, United States
- St Louis, Missouri, United States
- Camden, New Jersey, United States
- Edison, New Jersey, United States
- Newark, New Jersey, United States
- New York, New York, United States
- Syracuse, New York, United States
- The Bronx, New York, United States
- Valhalla, New York, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Toledo, Ohio, United States
+ 9 more site(s).
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, 40 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Kansas City, Kansas, United States and 23 more location(s). 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.