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

NCT04923984 | Recruiting

• 1 other identifier: HS24152(B2020-077)
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subdural Hematoma

Keywords

Embolization; Middle Meningeal Artery; Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Size

  30 days and 90 days

• Mortality within 90-days

  up to 90-days

• 90 day Modified Rankin Score </=3

  90-days

• Reduction of CSDH size at 90-days

  90-days

• Morbidity within 90-days

  up to 90-days

Study Arms (1)

Embolization of Middle Meningeal Artery for Subdural Hematoma

EXPERIMENTAL

All patients with CSDH will undergo embolization of Middle Meningeal artery

Procedure: Embolization of the middle meningeal artery

Interventions

Embolization of the middle meningeal artery PROCEDURE

embolization of the middle meningeal artery with an embolic agent (Microparticles, liquid embolic agents, SwiftPAC coils or others).

Embolization of Middle Meningeal Artery for Subdural Hematoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences centre

Winnipeg MB, Manitoba, R3A 1R9, Canada

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural; Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Chronic Disease; Disease Attributes

Study Officials

• Jai Shankar, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jai Shankar, MD

CONTACT

4313734164; shivajai1@gmail.com

Susan Alcock, RN

CONTACT

2047893669; susan.alcock@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: May 1, 2021
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

CA (1)