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Middle Meningeal Artery Embolization for Subdural Hematoma (MEMBRANE Trial)

Q: To what extent is the clinical trial being populated with participants?

Affirmative. According to the information featured on clinicaltrials.gov, this trial is currently recruiting patients and has done since it was first posted in May 2021. This study aims to admit 376 people across two sites before its last update on November 28th 2022.

Q: Are there any opportunities to participate in this research endeavor at the moment?

The research study, which was formally posted on May 27th 2021, is still actively seeking participants. The last time the trial details were updated was November 28th 2022.

Q: Is enrollment open to elderly individuals who are 85 years old or older?

The study is open to <a href="https://www.withpower.com/clinical-trials/all">all</a> participants aged 18-90, with a separate trial available for minors and another specifically dedicated to seniors above 65.

Q: Could I be eligible to join this research endeavor?

This clinical trial is searching for 376 patients aged 18-90 who suffer from hematoma and subdural chronic. To be eligible, <a href="https://www.withpower.com/clinical-trials/all">all</a> applicants must have a pre-randomization Modified Rankin Scale score of 3 or lower.

N/A

Waitlist Available

Led By Ansaar Rai, MD

Research Sponsored by Cerenovus, Part of DePuy Synthes Products, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of chronic subdural hematoma

Pre-randomization mRS </= 3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days post procedure

Awards & highlights

MEMBRANE Trial Summary

This trial is testing a new treatment for chronic subdural hematomas, which are bleedings in the brain. The new treatment is compared to the standard of care.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, embolization procedures like this can generally cause discomfort at the injection site, bleeding complications, risk of stroke if particles block off unintended vessels and possible allergic reactions to materials used.

MEMBRANE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with chronic subdural hematoma.

Select...

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

MEMBRANE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~365 days post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Effectiveness

Safety: Change in mRS

Other outcome measures

Health Economics

MEMBRANE Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Experimental: Observational Cohort: Treatment ArmExperimental Treatment1 Intervention

Standard of Care Medical Management + Embolization

Group II: Experimental: Interventional Cohort: Treatment ArmExperimental Treatment1 Intervention

Standard of Care Surgery + Embolization

Group III: Active Comparator: Observational Cohort: Control ArmActive Control1 Intervention

Medical Management Only

Group IV: Active Comparator: Interventional Cohort: Control ArmActive Control1 Intervention

Standard of Care Surgery Only

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

7 Previous Clinical Trials

5,023 Total Patients Enrolled

Ansaar Rai, MDPrincipal InvestigatorWest Virginia University

1 Previous Clinical Trials

150 Total Patients Enrolled

Christopher Kellner, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

1 Previous Clinical Trials

500 Total Patients Enrolled

Media Library

Experimental: Interventional Cohort: Treatment Arm Clinical Trial Eligibility Overview. Trial Name: NCT04816591 — N/A

Subdural Hematoma Research Study Groups: Experimental: Observational Cohort: Treatment Arm, Active Comparator: Observational Cohort: Control Arm, Active Comparator: Interventional Cohort: Control Arm, Experimental: Interventional Cohort: Treatment Arm

Subdural Hematoma Clinical Trial 2023: Experimental: Interventional Cohort: Treatment Arm Highlights & Side Effects. Trial Name: NCT04816591 — N/A

Experimental: Interventional Cohort: Treatment Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT04816591 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the clinical trial being populated with participants?

"Affirmative. According to the information featured on clinicaltrials.gov, this trial is currently recruiting patients and has done since it was first posted in May 2021. This study aims to admit 376 people across two sites before its last update on November 28th 2022."

Answered by AI

Are there any opportunities to participate in this research endeavor at the moment?

"The research study, which was formally posted on May 27th 2021, is still actively seeking participants. The last time the trial details were updated was November 28th 2022."

Answered by AI

Is enrollment open to elderly individuals who are 85 years old or older?

"The study is open to all participants aged 18-90, with a separate trial available for minors and another specifically dedicated to seniors above 65."

Answered by AI

Could I be eligible to join this research endeavor?

"This clinical trial is searching for 376 patients aged 18-90 who suffer from hematoma and subdural chronic. To be eligible, all applicants must have a pre-randomization Modified Rankin Scale score of 3 or lower."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA

2021. "Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04816591.