Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada -EMMA-Can
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Manitoba
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Radiographic recurrence
Study Overview
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 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic.
Exclusion Criteria
- •If informed consent cannot be obtained from the patient or their substitute decision maker.
- •Known allergy to liquid embolic agent
Arms & Interventions
Embolization of Middle Meningeal Artery for Subdural Hematoma
All patients with CSDH will undergo embolization of Middle Meningeal artery
Intervention: Embolization of the middle meningeal artery (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Size(30 days and 90 days)
- Mortality within 90-days(up to 90-days)
- 90 day Modified Rankin Score </=3(90-days)
- Reduction of CSDH size at 90-days(90-days)
- Morbidity within 90-days(up to 90-days)
- 90-day MOCA and EQ-5D-5L health score(Day 90)
- Discharge destination(up to 100 weeks)
- Length of hospital stay(up to 100 weeks)
Investigators
Jai Shankar
Professor
University of Manitoba