Embolization of Middle Meningeal Artery for Subdural Hema... | NCT04923984

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

NCT04923984

Sponsor

University of Manitoba

Status

Recruiting

Last Update Posted

Feb 3, 2026Actual

Enrollment

1,000Estimated

Phase

Not Applicable

Conditions

Subdural Hematoma

Interventions

Embolization of the middle meningeal artery

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2021Actual

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Jun 7, 2021

First Submission Date that Met QC Criteria

Jun 7, 2021

First Posted Date

Jun 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2026

Last Update Posted Date

Feb 3, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jai Shankar, Professor, University of ManitobaPrincipal Investigator

Lead Sponsor

University of ManitobaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jai Shankar, MD	Contact	4313734164		shivajai1@gmail.com
Susan Alcock, RN	Contact	2047893669		susan.alcock@umanitoba.ca

Overall Officials

Name	Affiliation	Role
Jai Shankar, MD	University of Manitoba	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Sciences centre	Recruiting	Winnipeg MB	Manitoba	R3A 1R9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D006408	Hematoma, Subdural
D020200	Hematoma, Subdural, Chronic

Ancestor Terms

ID	Term
D020198	Intracranial Hemorrhage, Traumatic
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided