What side effects are associated with this type of intervention?

Common treatments for subdural hematoma, including surgical drainage, medical management, and embolization procedures like EMMA, have various side effects. Surgical drainage can result in infection, bleeding, and potential brain injury. Medical management with anticoagulants may cause bleeding and gastrointestinal issues. Embolization procedures, such as EMMA, can lead to vessel injury, non-target embolization causing ischemia, and allergic reactions to the embolic material.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments of Subdural Hematoma that are similar to the Embolization of the Middle Meningeal Artery (EMMA). Generally, the standard treatment for chronic subdural hematoma includes surgical drainage. The EMMA procedure, which aims to reduce blood flow to the area and potentially decrease the recurrence of hematoma, is currently being studied and is not yet a widely established treatment. Other related treatments that manage blood flow and reduce hematoma recurrence are still under investigation.

What other types of research exist?

Promising novel alternatives to EMMA for Subdural Hematoma patients include: 1) Minimally invasive surgical techniques such as endoscopic evacuation, which allows for precise removal of hematoma with minimal disruption to surrounding tissues. 2) The use of pharmacological agents like tranexamic acid, which helps in reducing rebleeding by stabilizing blood clots. 3) Advanced imaging-guided interventions that improve the accuracy of hematoma evacuation and reduce recurrence rates. These alternatives are being explored to enhance patient outcomes and reduce the need for repeat procedures.

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Middle Meningeal Artery Embolization for Subdural Hematoma (EMMA-Can Trial)

N/A

Recruiting

Led By Jai JS Shankar, MD

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

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

Must have

Modified Rankin Scale of ≤2 at baseline

Patients requiring surgery or has at least 10 mm of CSDH on CT head and has one or more symptoms attributable to CSDH, including headache, cognitive impairment, ataxia, seizure, focal neurologic deficit, or decreased consciousness.

Must not have

Contraindication to the embolization procedure such as severe renal dysfunction, or pregnancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day of discharge, 30-days, and 90-days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether an additional procedure can help prevent brain bleeds in patients who have already received usual care. The goal is to see if this extra step can reduce the risk of the brain bleed coming back.

Who is the study for?

This trial is for patients with chronic subdural hematoma (CSDH) who can function independently (Modified Rankin Scale ≤2), have a CT scan that allows vascular access for the procedure, and symptoms like headache or cognitive issues due to CSDH. It's not for those with CSDH from conditions like tumors, severe kidney problems, pregnancy, or life expectancy under 6 months.

What is being tested?

The EMMA-Can study tests if adding embolization of the middle meningeal artery (EMMA) to standard treatments reduces recurrence in CSDH patients. Participants are randomly chosen to receive either just standard care or standard care plus EMMA.

What are the potential side effects?

Potential side effects may include reactions related to the embolic agent used during EMMA, complications from invasive vascular procedures, and typical risks associated with surgical drainage when applicable.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can carry out all my usual duties with slight disability.

Select...

I need surgery for a brain condition causing symptoms like headaches or seizures.

Exclusion Criteria

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

Select...

I am not pregnant and do not have severe kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day of discharge, 30-days, and 90-days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day of discharge, 30-days, and 90-days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day of discharge, 30-days, and 90-days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Chronic Subdural Hematoma (CSDH) recurrence at 90-days

Secondary study objectives

Mortality

Reduction of CSDH size at 90-days

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional ArmExperimental Treatment1 Intervention

Patients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage and/or medical management for the CSDH as per the standard of care in the institution. These patients will then undergo EMMA within 48 hours after finishing the surgical drainage. The embolic agent and use of general anesthesia vs conscious sedation will be left to operators' preference and the institutional protocol. All patients will be followed as per the institutional standard of the care. Any peri-procedural complications and change in clinical status will be recorded.

Group II: Control ArmActive Control1 Intervention

Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage and/or medical management for the CSDH.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Embolization of the Middle Meningeal Artery

2020

N/A

~40

0 / 3Eligibility 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

The most common treatments for Subdural Hematoma (SDH) include surgical drainage, medical management, and embolization of the middle meningeal artery (EMMA). Surgical drainage physically removes the hematoma to relieve pressure on the brain. Medical management involves medications to control symptoms and prevent complications. The EMMA treatment reduces blood flow to the area by embolizing the middle meningeal artery, potentially decreasing the recurrence of the hematoma. This is crucial for SDH patients as it targets the underlying issue of ongoing bleeding, reducing the risk of recurrence and associated complications.