An interventional study of Embolization of the middle meningeal artery in Subdural Hematoma, sponsored by University of Manitoba. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by University of Manitoba · Not applicable, Interventional, and Diagnostic
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.
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.
44 studies on the registry are indexed under Hematoma, Subdural; 15 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 105 across 30 interventional studies indexed under Hematoma, Subdural.
Browse Hematoma, Subdural studies →University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients with CSDH will undergo embolization of Middle Meningeal artery
Procedure: Embolization of the middle meningeal artery
embolization of the middle meningeal artery with an embolic agent (Microparticles, liquid embolic agents, SwiftPAC coils or others).
Radiographic recurrence
Recurrence of CSDH on imaging (CT scan or MRI) of head .
Time frame: 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
Time frame: up to 90-days from EMMA
Size
Change in size of the CSDH
Time frame: 30 days and 90 days
Mortality within 90-days
Peri-procedural mortality related to EMMA.
Time frame: up to 90-days
90 day Modified Rankin Score </=3
Percentage of patients with a Modified Rankin score \</=3
Time frame: 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
Time frame: 90-days
Morbidity within 90-days
peri-procedural morbidity related to EMMA such as puncture site hematoma, arterial dissection or stroke
Time frame: 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
Time frame: Day 90
Discharge destination
discharge location from acute care
Time frame: up to 100 weeks
Length of hospital stay
number of days of acute care hospitalization
Time frame: up to 100 weeks
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