Chronic Subdural HematomaEMMA-CanNCT04750200
Management of CSDH With or Without EMMA- a Randomized Control Trial
A study testing Embolization of the Middle Meningeal Artery in people with Chronic Subdural Hematoma, run by University of Manitoba at 1 site in Canada.
Trial summary
EMMA-Can is a prospective randomized open-label, blinded end point (PROBE) study, that will assess the recurrence risk and safety of embolization of the middle meningeal (EMMA) when added to standard of care treatment (surgical drainage) of chronic subdural hematoma (CSDH) compared to surgical treatment alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic 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
- 192 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2021to 31 Aug 2026
- 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
- Premorbid Modified Rankin Scale of ≤2;
- Patients with unilateral symptomatic primary or recurrent CSDH >10 mm in thickness on CT head undergoing surgical drainage;
- CT Angiogram of head and neck which favors vascular access for EMMA and lacks dangerous anatomic variations;
- Patients over 18 years of age; no upper age limit.
Who cannot join
- If informed consent cannot be obtained from the patients or their substitute decision makers;
- Patients with bilateral symptomatic CSDH;
- CTA showing persistent communication between branches of middle meningeal artery and that of internal carotid arteries;
- Contraindication to the embolization procedure such as severe renal dysfunction (eGFR<30), or pregnancy;
- Life expectancy < 6 months;
- Known allergy to Onyx;
Show all 9Show fewer
- Acute subdural hematoma with homogenous hyperdensity on CT scan;
- Secondary CSDH that may likely be due to the underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or prior craniotomy;
- Patients needing treatment with 2 weeks of dexamethasone or tranexamic acid will be contraindicated in the study patients to avoid confounding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Chronic Subdural Hematoma With or Without Embolization of Middle Meningeal Artery in Canada (EMMA-Can)- A Randomized Control Trial.
EMMA-Can is a prospective randomized open-label, blinded end point (PROBE) study, that will assess the recurrence risk and safety of embolization of the middle meningeal (EMMA) when added to standard of care treatment (surgical drainage) of chronic subdural hematoma (CSDH) compared to surgical treatment alone.
Read the detailed description
All patients in clinical need of surgical drainage for the CSDH will be randomized in our study. Patients that present in the Emergency Department (ED) or neurosurgery clinic will be assessed for standard of care treatment options based on their presenting symptoms. Patients will then by screened for study eligibility based on the study inclusion and exclusion criteria. After screening and consenting patients will be randomized in to the control arm or interventional arm.
Patients randomized to the control arm will receive institutional standard of care treatment (surgical drainage) of the CSDH.
Patients randomized to the interventional arm will receive institutional standard of care treatment (surgical drainage) of the CSDH followed by EMMA, with Onyx and under a general anesthetic within 72 hours of surgical drainage.
All patients will be followed as per the institutional standard of the care. Any peri-procedural complications and change in clinical status will be recorded. The risk of recurrence at 90-days will be assessed in all patients.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Embolization of the Middle Meningeal Artery
- Keywords
- chronic subdural hematoma, Embolization of Middle Meningeal artery (EMMA)
- Medical subject headings
- 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
EMMA is performed inside of the blood vessels where tiny catheters are used to deliver a liquid embolic agent (Onyx) to block small blood vessels supplying the brain coverings.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage) for the CSDH. |
| Interventional Arm | Experimental | Patients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage) for the CSDH followed by EMMA within 72 hours of surgical drainage. The embolization will be done using a liquid embolic agent (Onyx) and will be done under a general anesthesia or conscious sedation as per the operator's preference. All patients will be followed as per the institutional standard of the care. Any peri-procedural complications and change in clinical status will be recorded. 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.
Chronic Subdural Hematoma (CSDH) recurrence at 90-days on CT scan
Symptomatic recurrence of the CSDH on CT scan of head within 90-days from EMMA
Measured: 90-days
Secondary outcomes (7)
90 day mRs ≤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
Mortality within 90-days
Peri-procedural mortality related to EMMA
Measured: "up to 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: "Discharge Day"
Length of hospital stay
Number of days of acute care hospitalization
Measured: "Discharge Day"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Aug 2021
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-label randomized control trial
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
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 JS Shankar, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750200
- Sponsor's protocol ID
- HS24435 (B2020:120)
- Acronym
- EMMA-Can
- Status last verified
- Dec 2025
- First submitted
- 8 Feb 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shankar JJS, Alcock S, Kashani N, Darsaut T, Wang BH, Dos Santos MP, Milot G, O'Kelly C, Kelly ME, Iancu D, Cora A, Marotta T, van Adel B, Kishore K, Drake B, Lesiuk H, Carrondo-Cottin S, Rempel J, Ahmed U, Chaalala C, Silvaggio J, Kaderali Z, McEachern J, Salam MSA, Sinha N, Marin R, Leung YS, Balshaw R, Fleetwood I, Jiang D, Menon BK, Singh N, Zeiler FA; EMMA-Can investigators. Management of Chronic Subdural Hematoma With Adjunctive Embolization of Middle Meningeal Artery: The EMMA-Can Randomized Clinical Trial. JAMA. 2026 May 26;335(20):1787-1795. doi: 10.1001/jama.2026.4910.
PubMed 42060283
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Chronic Subdural Hematoma With or Without Embolization of Middle Meningeal Artery in Canada (EMMA-Can)- A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04750200
- Acronym / sponsor ID
- EMMA-Can / HS24435 (B2020:120)
- Conditions
- Chronic Subdural Hematoma
- Keywords
- chronic subdural hematoma, Embolization of Middle Meningeal artery (EMMA)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 11 Feb 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 randomized open-label, blinded end point (PROBE) study, that will assess the recurrence risk and safety of embolization of the middle meningeal (EMMA) when added to standard of care treatment (surgical drainage) of chronic subdural hematoma (CSDH) compared to surgical treatment alone.
Detailed description
All patients in clinical need of surgical drainage for the CSDH will be randomized in our study. Patients that present in the Emergency Department (ED) or neurosurgery clinic will be assessed for standard of care treatment options based on their presenting symptoms. Patients will then by screened for study eligibility based on the study inclusion and exclusion criteria. After screening and consenting patients will be randomized in to the control arm or interventional arm.
Patients randomized to the control arm will receive institutional standard of care treatment (surgical drainage) of the CSDH.
Patients randomized to the interventional arm will receive institutional standard of care treatment (surgical drainage) of the CSDH followed by EMMA, with Onyx and under a general anesthetic within 72 hours of surgical drainage.
All patients will be followed as per the institutional standard of the care. Any peri-procedural complications and change in clinical status will be recorded. The risk of recurrence at 90-days will be assessed in all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage) for the CSDH. |
| Interventional Arm | Experimental | Procedure: Embolization of the Middle Meningeal ArteryPatients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage) for the CSDH followed by EMMA within 72 hours of surgical drainage. The embolization will be done using a liquid embolic agent (Onyx) and will be done under a general anesthesia or conscious sedation as per the operator's preference. All patients will be followed as per the institutional standard of the care. Any peri-procedural complications and change in clinical status will be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Premorbid Modified Rankin Scale of ≤2;
- Patients with unilateral symptomatic primary or recurrent CSDH >10 mm in thickness on CT head undergoing surgical drainage;
- CT Angiogram of head and neck which favors vascular access for EMMA and lacks dangerous anatomic variations;
- Patients over 18 years of age; no upper age limit.
Key exclusion criteria (9 listed)
- If informed consent cannot be obtained from the patients or their substitute decision makers;
- Patients with bilateral symptomatic CSDH;
- CTA showing persistent communication between branches of middle meningeal artery and that of internal carotid arteries;
- Contraindication to the embolization procedure such as severe renal dysfunction (eGFR<30), or pregnancy;
- Life expectancy < 6 months;
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 ArteryEMMA is performed inside of the blood vessels where tiny catheters are used to deliver a liquid embolic agent (Onyx) to block small blood vessels supplying the brain coverings. | Procedure or surgery | Interventional Arm |
Primary outcome
Chronic Subdural Hematoma (CSDH) recurrence at 90-days on CT scan
Time frame: 90-days
Symptomatic recurrence of the CSDH on CT scan of head within 90-days from EMMA
7 secondary outcomes
90 day mRs ≤3
Time frame: 90-days
Reduction of CSDH size at 90-days
Time frame: 90-days
Mortality within 90-days
Time frame: "up to 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: "Discharge Day"
Length of hospital stay
Time frame: "Discharge Day"
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 28 Apr 2026.
- Derived from this study: PubMed 42060283Shankar JJS, Alcock S, Kashani N, Darsaut T, Wang BH, Dos Santos MP, Milot G, O'Kelly C, Kelly ME, Iancu D, Cora A, Marotta T, van Adel B, Kishore K, Drake B, Lesiuk H, Carrondo-Cottin S, Rempel J, Ahmed U, Chaalala C, Silvaggio J, Kaderali Z, McEachern J, Salam MSA, Sinha N, Marin R, Leung YS, Balshaw R, Fleetwood I, Jiang D, Menon BK, Singh N, Zeiler FA; EMMA-Can investigators. Management of Chronic Subdural Hematoma With Adjunctive Embolization of Middle Meningeal Artery: The EMMA-Can Randomized Clinical Trial. JAMA. 2026 May 26;335(20):1787-1795. doi: 10.1001/jama.2026.4910.
- Individual participant dataSharing planned: No
Related trials for Chronic Subdural Hematoma
RecruitingObservational study
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH)
Subdural Hematoma, Subdural Hematoma, Chronic
Recruiting
MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma
Subdural Hematoma
Active, not recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
RecruitingObservational study
Chronic Subdural Hematoma Embolization With Detachable Coils
Chronic Subdural Hemorrhage (cSDH)
RecruitingObservational study
Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)
Chronic Subdural Hematoma
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. This study is not recruiting at the moment.
Jai JS 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 Chronic 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Subdural Hematoma (CSDH) recurrence at 90-days on CT scan (time frame: 90-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04750200, which also lists 1 linked publication.
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 28 Apr 2026.