Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada (EMMA Can) (EMMA-Can)

Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada -EMMA-Can

EMMA-Can is a prospective cohort study to assess the safety and effectiveness of MMA-embolization for the treatment of CSDH.

Hypothesis- EMMA reduces the recurrence rate of CSDH with or without concomitant surgical evacuation.

Study Overview

• Status: Recruiting
• Conditions: Subdural Hematoma
• Intervention / Treatment: Procedure: Embolization of the middle meningeal artery

Detailed Description

The purpose of our study is to conduct a prospective cohort study to assess the safety and effectiveness of MMA embolization for the treatment of CSDH. All patients with CSDH presenting to the emergency room or to neurosurgical outpatient clinic will be screened for potential enrollment. If the subject is willing to participate an informed consent will be obtained.

All patients presenting to the emergency room or in neurosurgery clinic with CSDH diagnosed on CT scan will be considered for the study. If the patient needs emergent evacuation for clinical reasons, patient will be taken for surgical evacuation before consideration of EMMA. Patients that are more likely to have recurrence after surgical evacuation are those with recurrent CSDH, on antiplatelet or antithrombotic treatment. The EMMA could be used as primary treatment or in conjunction with surgery in these patients or in patients who may not be good surgical candidate.

Follow up - All patients will be followed after discharge from the hospital at 1, 3, 6 and 12 months interval. The follow up at 3 months will include plain CT head of the patient, which is standard of care for most patients. The follow up at 6 and 12 months will be only clinical follow up.

Patients will be assessed for recurrence of CSDH on CT scan of head. Symptoms associated with the recurrence will be recorded. The size of the CSDH will be measured and compared to previous scans and peri-procedural morbidity and mortality related to EMMA will be sought. This will be done at 3 months post EMMA.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jai Shankar, MD; Phone Number: 4313734164; Email: shivajai1@gmail.com
• Study Contact Backup: Name: Susan Alcock, RN; Phone Number: 2047893669; Email: susan.alcock@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg MB, Manitoba, Canada, R3A 1R9
      • Recruiting
      • Health Sciences Centre
      • Contact: Jai Shankar, MD FRCPC; Phone Number: 431 373 4164; Email: shivajai1@gmail.com
      • Principal Investigator: Jai Shankar, MD FRCPC
      • Contact: Susan Alcock; Phone Number: 204 789 3996; Email: susan.alcock@umanitoba.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic.

Exclusion Criteria:

• If informed consent cannot be obtained from the patient or their substitute decision maker.
• Known allergy to liquid embolic agent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embolization of Middle Meningeal Artery for Subdural Hematoma; All patients with CSDH will undergo embolization of Middle Meningeal artery	Procedure: Embolization of the middle meningeal artery; embolization of the middle meningeal artery with an embolic agent (Microparticles, liquid embolic agents, SwiftPAC coils or others).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic recurrence	Recurrence of CSDH on imaging (CT scan or MRI) of head .	up to 90-days for EMMA
Symptomatic recurrence	Symptomatic recurrence attributable to the side of the CSDH on imaging (CT scan or MRI) of head	up to 90-days from EMMA

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size	Change in size of the CSDH	30 days and 90 days
Mortality within 90-days	Peri-procedural mortality related to EMMA.	up to 90-days
90 day Modified Rankin Score </=3	Percentage of patients with a Modified Rankin score </=3	90-days
Reduction of CSDH size at 90-days	Reduction of the size of the CSDH on CT scan of the head at 90-days from EMMA	90-days
Morbidity within 90-days	peri-procedural morbidity related to EMMA such as puncture site hematoma, arterial dissection or stroke	up to 90-days
90-day MOCA and EQ-5D-5L health score	score on the Montreal Cognitive Assessment test and score on the EQ-5D-5L assessment	Day 90
Discharge destination	discharge location from acute care	up to 100 weeks
Length of hospital stay	number of days of acute care hospitalization	up to 100 weeks

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Jai Shankar, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Embolization; Chronic Subdural Hematoma; Middle Meningeal Artery
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Pathological Conditions, Signs and Symptoms; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: HS24152(B2020-077)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No