What side effects are associated with this type of intervention?

The most common side effects of embolization treatments for subdural hematoma, such as TRUFILL n-BCA MMA embolization, include headache, nausea, and localized pain at the catheter insertion site. There is also a risk of complications such as infection, bleeding, and, in rare cases, stroke or damage to surrounding blood vessels. These procedures are generally well-tolerated, but patients should be monitored for any adverse reactions.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for treatments of Subdural Hematoma that are similar to TRUFILL n-BCA MMA embolization. Generally, treatments for subdural hematomas have included surgical interventions such as craniotomy or burr hole drainage to remove the hematoma. Embolization techniques, like the one being studied with TRUFILL n-BCA, represent a newer approach aimed at blocking blood flow to reduce hematoma recurrence. This method is still under investigation and may offer a less invasive alternative to traditional surgical methods.

What other types of research exist?

Promising novel alternatives to TRUFILL n-BCA MMA embolization for subdural hematoma patients include middle meningeal artery (MMA) embolization using other embolic agents such as Onyx or Squid, and minimally invasive surgical techniques like endoscopic evacuation. These alternatives aim to reduce recurrence rates and improve patient outcomes.

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Middle Meningeal Artery Embolization for Subdural Hematoma (MEMBRANE Trial)

Q: What is the mechanism of action of this treatment?

Subdural hematomas are typically treated through surgical interventions such as craniotomy or burr hole drainage, which aim to remove the accumulated blood and relieve pressure on the brain. Another emerging treatment is embolization, specifically using agents like TRUFILL n-BCA, which involves blocking the middle meningeal artery to reduce blood flow to the hematoma site. This method helps prevent further bleeding and promotes the resolution of the hematoma. Understanding these mechanisms is crucial for patients as it informs them about how these treatments can effectively manage their condition, potentially leading to better outcomes and fewer complications.

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

Must not have

Prior treatment of target subdural hematoma

Acute subdural hematoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days post procedure

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with chronic subdural hematoma.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated for a subdural hematoma before.

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I have a recent brain bleed under its outer covering.

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I am not pregnant, breastfeeding, or planning to become pregnant during the study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effectiveness

Secondary study objectives

Safety: Change in mRS

Other study objectives

Health Economics

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Subdural hematomas are typically treated through surgical interventions such as craniotomy or burr hole drainage, which aim to remove the accumulated blood and relieve pressure on the brain. Another emerging treatment is embolization, specifically using agents like TRUFILL n-BCA, which involves blocking the middle meningeal artery to reduce blood flow to the hematoma site. This method helps prevent further bleeding and promotes the resolution of the hematoma. Understanding these mechanisms is crucial for patients as it informs them about how these treatments can effectively manage their condition, potentially leading to better outcomes and fewer complications.