Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada (EMMA Can)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Embolization of the middle meningeal artery.
- Who it may be relevant to
- Registry conditions: Subdural Hematoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada -EMMA-Can
Overview
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.
Interventions
- 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).
Primary outcome measures
- Radiographic recurrence [Time frame: up to 90-days for EMMA]
- Symptomatic recurrence [Time frame: up to 90-days from EMMA]
Secondary outcome measures (8)
- Size [Time frame: 30 days and 90 days]
- Mortality within 90-days [Time frame: up to 90-days]
- 90 day Modified Rankin Score </=3 [Time frame: 90-days]
- Reduction of CSDH size at 90-days [Time frame: 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: up to 100 weeks]
- Length of hospital stay [Time frame: up to 100 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- Health Sciences centre — Winnipeg MB
Identifiers
NCT: NCT04923984 · HS24152(B2020-077)