Subdural HematomaEMMA-CanNCT04923984
Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada (EMMA Can)
A study testing Embolization of the middle meningeal artery in people with Subdural Hematoma, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subdural Hematoma
- What is being tested?
- Embolization of the middle meningeal artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2021to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic.
Who cannot join
- If informed consent cannot be obtained from the patient or their substitute decision maker.
- Known allergy to liquid embolic agent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Health Sciences centre
Winnipeg MB, Manitoba, R3A 1R9
Jai Shankar, MD FRCPC, 431 373 4164, shivajai1@gmail.com
Susan Alcock, 204 789 3996, susan.alcock@umanitoba.ca
About this study
Official title: 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.
Read the 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
- Being tested
- Embolization of the middle meningeal artery
- Keywords
- Embolization, Middle Meningeal Artery, Chronic Subdural Hematoma
- Medical subject headings
- Hematoma, Subdural, Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embolization of the middle meningeal arteryProcedure or surgery
embolization of the middle meningeal artery with an embolic agent (Microparticles, liquid embolic agents, SwiftPAC coils or others).
| Study group | Role | What they receive |
|---|---|---|
| Embolization of Middle Meningeal Artery for Subdural Hematoma | Experimental | All patients with CSDH will undergo embolization of Middle Meningeal artery Receives: Procedure: Embolization of the middle meningeal artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic recurrence
Recurrence of CSDH on imaging (CT scan or MRI) of head .
Measured: 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
Measured: up to 90-days from EMMA
Secondary outcomes (8)
Size
Change in size of the CSDH
Measured: 30 days and 90 days
Mortality within 90-days
Peri-procedural mortality related to EMMA.
Measured: up to 90-days
90 day Modified Rankin Score </=3
Percentage of patients with a Modified Rankin score </=3
Measured: 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
Measured: 90-days
Morbidity within 90-days
peri-procedural morbidity related to EMMA such as puncture site hematoma, arterial dissection or stroke
Measured: 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
Measured: Day 90
Discharge destination
discharge location from acute care
Measured: up to 100 weeks
Length of hospital stay
number of days of acute care hospitalization
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 May 2021
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subdural HematomaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jai Shankar, University of Manitoba
- Investigators
- Jai Shankar, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923984
- Sponsor's protocol ID
- HS24152(B2020-077)
- Acronym
- EMMA-Can
- Status last verified
- Feb 2026
- First submitted
- 7 Jun 2021
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada -EMMA-Can
- ClinicalTrials.gov ID
- NCT04923984
- Acronym / sponsor ID
- EMMA-Can / HS24152(B2020-077)
- Conditions
- Subdural Hematoma
- Keywords
- Embolization, Middle Meningeal Artery, Chronic Subdural Hematoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolization of Middle Meningeal Artery for Subdural Hematoma | Experimental | Procedure: Embolization of the middle meningeal arteryAll patients with CSDH will undergo embolization of Middle Meningeal artery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic.
Key exclusion criteria (2 listed)
- If informed consent cannot be obtained from the patient or their substitute decision maker.
- Known allergy to liquid embolic agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embolization of the middle meningeal arteryembolization of the middle meningeal artery with an embolic agent (Microparticles, liquid embolic agents, SwiftPAC coils or others). | Procedure or surgery | Embolization of Middle Meningeal Artery for Subdural Hematoma |
Primary outcome
Radiographic recurrence
Time frame: up to 90-days for EMMA
Recurrence of CSDH on imaging (CT scan or MRI) of head .
Symptomatic recurrence
Time frame: up to 90-days from EMMA
Symptomatic recurrence attributable to the side of the CSDH on imaging (CT scan or MRI) of head
8 secondary outcomes
Size
Time frame: 30 days and 90 days
Mortality within 90-days
Time frame: up to 90-days
90 day Modified Rankin Score </=3
Time frame: 90-days
Reduction of CSDH size at 90-days
Time frame: 90-days
Morbidity within 90-days
Time frame: up to 90-days
90-day MOCA and EQ-5D-5L health score
Time frame: Day 90
Discharge destination
Time frame: up to 100 weeks
Length of hospital stay
Time frame: up to 100 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jai Shankar, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization of the middle meningeal artery in people with Subdural Hematoma, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jai Shankar, MD (4313734164, shivajai1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic recurrence (time frame: up to 90-days for EMMA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.