Middle Meningeal Artery Embolization for Subdural Hematoma

(MEMBRANE Trial)

Recruiting at 32 trial locations

Overseen By Lillian Ma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.

Disqualifiers: Acute subdural hematoma, Intracranial tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Varies

376 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment for brain bleeds. It targets patients who may not fully benefit from standard care alone. The treatment works by using a glue-like substance to block blood vessels and stop bleeding.

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 data supports the effectiveness of the treatment TRUFILL n-BCA for subdural hematoma?

Research shows that middle meningeal artery embolization, which can use the n-BCA liquid embolic system, is becoming a popular and minimally invasive treatment for chronic subdural hematomas. Studies indicate it is effective in managing these conditions, with some reports highlighting its safety and ability to reduce hematoma size. ^{1 2 3 4 5}

Is middle meningeal artery embolization generally safe for humans?

Middle meningeal artery embolization is considered a safe treatment option for chronic subdural hematomas, though rare complications like pseudoaneurysms (abnormal bulging of an artery) can occur, especially with certain techniques. Overall, studies suggest it is a minimally invasive and safe procedure for managing these conditions. ^{1 3 6 7 8}

How does middle meningeal artery embolization differ from other treatments for subdural hematoma?

Middle meningeal artery embolization is a minimally invasive treatment that involves blocking the blood supply to the area of the brain affected by a subdural hematoma, which can help reduce the hematoma without the need for open surgery. This approach is particularly useful for patients who are elderly or have other health issues that make traditional surgery riskier. ^{1 2 3 8 9}

Research Team

Christopher Kellner, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Ansaar Rai, MD

Principal Investigator

West Virginia University

Eligibility Criteria

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

Completed informed consent

I have been diagnosed with chronic subdural hematoma.

My disability level allows me to walk and take care of myself.

Exclusion Criteria

Suspected additional infection by germs.

You have a tumor or mass in your brain shown on a CT or MRI scan.

Current involvement in another clinical trial that may confound study endpoints

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care and may undergo TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

180 days

Long-term follow-up

Participants are monitored for health economics outcomes such as hospital days

365 days

Treatment Details

Interventions

• TRUFILL n-BCA

Trial Overview The study compares standard care alone versus standard care plus TRUFILL n-BCA embolization for treating chronic subdural hematomas. Participants are divided into groups: some observe only while others receive interventions; they're assigned randomly to either continue usual treatments or get additional artery embolization.

Participant Groups

Group I: Experimental: Observational Cohort: Treatment Arm Experimental Treatment 1 Intervention

Standard of Care Medical Management + Embolization

Group II: Experimental: Interventional Cohort: Treatment Arm Experimental Treatment 1 Intervention

Standard of Care Surgery + Embolization

Group III: Active Comparator: Observational Cohort: Control Arm Active Control 1 Intervention

Medical Management Only

Group IV: Active Comparator: Interventional Cohort: Control Arm Active Control 1 Intervention

Standard of Care Surgery Only

Who Is Running the Clinical Trial?

Cerenovus, Part of DePuy Synthes Products, Inc.

Lead Sponsor

Trials

10

Recruited

5,600+

Findings from Research

Middle meningeal artery embolization is a safe and effective treatment for chronic subdural hematomas, showing a low recurrence rate of 4.1% and a reoperation rate of 4.2% among 382 patients studied.

Using Onyx as the embolic agent resulted in the lowest rates of recurrence and complications, while a combination of polyvinyl alcohol and coils led to the best overall clinical outcomes, suggesting that the choice of embolic agent can significantly impact treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embolic Agent Choice in Middle Meningeal Artery Embolization as Primary or Adjunct Treatment for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. Ku, JC., Dmytriw, AA., Essibayi, MA., et al.[2023]

MMA embolization is a safe and effective treatment for chronic subdural hematoma (CSDH), with a low recurrence rate of 3.6% and no reported complications in a review of 15 studies involving 193 procedures.

In our clinical experience with 8 patients treated using Onyx, all experienced symptom relief and significant reduction in hematoma size, further supporting the efficacy of this minimally invasive approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Embolization for Chronic Subdural Hematoma: Systematic Review and Case Series. Waqas, M., Vakhari, K., Weimer, PV., et al.[2020]

Middle meningeal artery embolization is increasingly recognized as a primary treatment for chronic subdural hematomas, with a growing body of literature supporting its use.

The authors present a case series of 11 patients undergoing this procedure, contributing to the understanding of its advantages and technical aspects in the context of existing studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Middle meningeal artery embolization for chronic subdural haematoma. Case series and literature review]. Stanishevskiy, AV., Babichev, KN., Vinogradov, EV., et al.[2021]

In a study of 61 patients with recurrent subdural hematoma, MMA embolization using diluted n-butyl cyanoacrylate (n-BCA) achieved complete obliteration of the targeted arteries in 100% of cases, demonstrating high efficacy in preventing further bleeding.

The procedure showed a low complication rate, with only 5% of patients experiencing recurrence of subdural hematoma and minimal risks of serious side effects such as cranial nerve palsy or stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma Using N-Butyl Cyanoacrylate With D5W Push Technique. Majidi, S., Matsoukas, S., De Leacy, RA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization Using Combined Particle Embolization and n-BCA with the Dextrose 5% in Water Push Technique for Chronic Subdural Hematomas: A Prospective Safety and Feasibility Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Embolic Agent Choice in Middle Meningeal Artery Embolization as Primary or Adjunct Treatment for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Embolization for Chronic Subdural Hematoma: Systematic Review and Case Series. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Recurrence and Coniglobus Volumetric Resolution of Subacute and Chronic Subdural Hematoma Post-Middle Meningeal Artery Embolization. [2021]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Middle meningeal artery embolization for chronic subdural haematoma. Case series and literature review]. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Iatrogenic pseudoaneurysm of the middle meningeal artery during embolization of bilateral chronic subdural hematomas. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization with Liquid Embolic Agents for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Transradial middle meningeal artery embolization for chronic subdural hematoma using Onyx: case series. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma Using N-Butyl Cyanoacrylate With D5W Push Technique. [2022]