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

NCT ID: NCT04923984

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2029-12-31

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.

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.

Conditions

Subdural Hematoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Embolization of Middle Meningeal Artery for Subdural Hematoma

All patients with CSDH will undergo embolization of Middle Meningeal artery

Group Type: EXPERIMENTAL

Embolization of the middle meningeal artery

Intervention Type: PROCEDURE

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

Interventions

Embolization of the middle meningeal artery

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Jai Shankar

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jai Shankar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Health Sciences centre

Winnipeg MB, Manitoba, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jai Shankar, MD

Role: CONTACT

shivajai1@gmail.com

4313734164

Susan Alcock, RN

Role: CONTACT

susan.alcock@umanitoba.ca

2047893669

Facility Contacts

Jai Shankar, MD FRCPC

Role: primary

shivajai1@gmail.com

431 373 4164

Susan Alcock

Role: backup

susan.alcock@umanitoba.ca

204 789 3996

Other Identifiers

HS24152(B2020-077)

Identifier Type: -

Identifier Source: org_study_id