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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embolization of the Middle Meningeal Artery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90-days |
| Measure | Description | Time Frame |
|---|---|---|
| 90 day mRs ≤3 | Percentage of patients with a Modified Rankin score ≤3. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jai JS Shankar, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba | Winnipeg | Manitoba | R3E 3P5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42060283 | Derived | 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. |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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open-label randomized control trial
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| 90-days |
| Mortality within 90-days | Peri-procedural mortality related to EMMA | "up to 90-days" |
| Morbidity within 90-days | Peri-procedural morbidity related to EMMA such as, puncture site hematoma, arterial dissection or stroke | " 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 | " Day 90" |
| Discharge destination | Discharge location from acute care | "Discharge Day" |
| Length of hospital stay | Number of days of acute care hospitalization | "Discharge Day" |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |