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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day of discharge, 30-days, and 90-days
Awards & highlights

EMMA-Can Trial Summary

This trial is testing whether a new treatment, embolization of the middle meningeal, is better than the standard of care treatment for chronic subdural hematoma.

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.Check my eligibility
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.See study design
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.

EMMA-Can Trial 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.

EMMA-Can Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Chronic Subdural Hematoma (CSDH) recurrence at 90-days
Secondary outcome measures
Mortality
Reduction of CSDH size at 90-days

EMMA-Can 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

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor
593 Previous Clinical Trials
199,188 Total Patients Enrolled
Jai JS Shankar, MDPrincipal InvestigatorUniversity of Manitoba

Media Library

Embolization of the Middle Meningeal Artery Clinical Trial Eligibility Overview. Trial Name: NCT04750200 — N/A
Subdural Hematoma Research Study Groups: Control Arm, Interventional Arm
Subdural Hematoma Clinical Trial 2023: Embolization of the Middle Meningeal Artery Highlights & Side Effects. Trial Name: NCT04750200 — N/A
Embolization of the Middle Meningeal Artery 2023 Treatment Timeline for Medical Study. Trial Name: NCT04750200 — N/A

Frequently Asked Questions

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

Is recruitment for this experimentation still taking place?

"Clinicaltrials.gov reflects that this research is actively looking for participants, having first been posted on August 1st 2021 and most recently modified on September 13th 2021."

Answered by AI

How many participants are undergoing this trial?

"Affirmative. Clinicaltrials.gov has information that this clinical trial is still actively recruiting patients, which began on August 1st of 2021 and was last amended on September 13th 2021. 200 participants are being recruited at a single site for the study."

Answered by AI
~81 spots leftby Dec 2025