Middle Meningeal Artery Embolization for Subdural Hematoma
(MEMBRANE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method for treating chronic subdural hematomas, which are persistent blood clots on the brain's surface. Researchers aim to determine if TRUFILL n-BCA embolization, combined with standard care, is more effective than standard care alone. The trial includes four groups: some will receive only standard surgery or medical care, while others will receive standard care plus the new treatment. Individuals diagnosed with chronic subdural hematoma who have not undergone previous treatment may be suitable candidates for this study. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance future treatment options.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that TRUFILL n-BCA embolization is safe for treating chronic subdural hematomas?
Research has shown that TRUFILL n-BCA, used in middle meningeal artery embolization, is generally safe. In one study, most patients did not experience serious side effects. The treatment was usually well-tolerated, and many patients showed positive results after three months.
Additionally, a review of this treatment method found it can be safely used in adults with chronic subdural hematomas (cSDH), with few complications reported. While no treatment is completely without risk, current evidence suggests that TRUFILL n-BCA is relatively safe for those considering this option.12345Why are researchers excited about this trial?
Researchers are excited about middle meningeal artery embolization for subdural hematoma because it offers a novel approach compared to traditional treatments like surgery and medical management. This technique involves using TRUFILL n-BCA, which is a liquid adhesive that blocks off the blood supply to the hematoma, potentially reducing its size and recurrence rates. Unlike standard surgical methods, which can be invasive, embolization is minimally invasive and could lead to quicker recovery times. Additionally, by directly targeting the blood vessels contributing to the hematoma, this method may decrease the need for repeat interventions, offering a promising alternative for patients.
What evidence suggests that TRUFILL n-BCA embolization is effective for treating chronic subdural hematomas?
Research has shown that using TRUFILL n-BCA for middle meningeal artery embolization can effectively treat chronic subdural hematomas (cSDH). In this trial, some participants will receive standard medical management or surgery alone, while others will receive standard care combined with embolization using TRUFILL n-BCA. One study found that this treatment outperforms standard care alone, leading to improved patient outcomes. The procedure involves blocking blood flow in specific brain vessels to help reduce the hematoma, a type of blood clot in the brain. Initial findings suggest that patients undergoing this treatment recover better and experience fewer complications. Experts generally agree that this method shows promise for managing cSDH.12567
Who Is on the Research Team?
Christopher Kellner, MD
Principal Investigator
MOUNT SINAI HOSPITAL
Ansaar Rai, MD
Principal Investigator
West Virginia University
Are You a Good Fit for This Trial?
This trial is for individuals with chronic subdural hematomas who have given informed consent, have a moderate or better ability to carry out daily activities (mRS ≤ 3), and a confirmed diagnosis. It excludes those with acute hematomas, severe consciousness impairment (Glasgow Coma Scale < 9), pregnant or lactating women, anyone planning pregnancy, participants in other trials that affect results, prior treatment of the hematoma, suspected infection within the brain, evidence of brain tumor/mass lesion, severe disability due to hematoma (Markwalder assessment ≥ 3), or life expectancy less than one year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care and may undergo TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for health economics outcomes such as hospital days
What Are the Treatments Tested in This Trial?
Interventions
- TRUFILL n-BCA
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cerenovus, Part of DePuy Synthes Products, Inc.
Lead Sponsor