EMMA-Can: Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada (EMMA Can)
Study Details
Study Description
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 SDH with or without concomitant surgical evacuation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 and 6 months interval. The follow up at 1 and 3 months will include plain CT head of the patient, which is standard of care for most patients. The follow up at 6 months will be only clinical follow up.
Patients will be assessed for recurrence of CSDH on CT scan of head. 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 1 and 3 months post EMMA.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Embolization of Middle Meningeal Artery for Subdural Hematoma 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.
|
Outcome Measures
Primary Outcome Measures
- Subdural Hematoma recurrence at 3 months [3 months]
Recurrence of SDH on CT scan of head within 3 months from EMMA.
Secondary Outcome Measures
- Size [1 month and 3 months]
Change in size of the CSDH
- Mortality [1month, 3months, 6months]
Peri-procedural morbidity and mortality related to EMMA.
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic
Exclusion Criteria:
-
When informed consent is not possible
-
Known allergy to liquid embolic agent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Health Sciences centre | Winnipeg MB | Manitoba | Canada | R3A 1R9 |
Sponsors and Collaborators
- University of Manitoba
Investigators
- Principal Investigator: Jai Shankar, MD, University of Manitoba
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS24152(B2020-077)