Subdural Hematoma
Conditions
Keywords
Embolization, Middle Meningeal Artery, Chronic Subdural Hematoma
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.
Interventions
embolization of the middle meningeal artery with an embolic agent (Microparticles, liquid embolic agents, SwiftPAC coils or others).
Sponsors
University of Manitoba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic recurrence | up to 90-days for EMMA | Recurrence of CSDH on imaging (CT scan or MRI) of head . |
| Symptomatic recurrence | up to 90-days from EMMA | Symptomatic recurrence attributable to the side of the CSDH on imaging (CT scan or MRI) of head |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Size | 30 days and 90 days | Change in size of the CSDH |
| Mortality within 90-days | up to 90-days | Peri-procedural mortality related to EMMA. |
| 90 day Modified Rankin Score </=3 | 90-days | Percentage of patients with a Modified Rankin score \</=3 |
| Reduction of CSDH size at 90-days | 90-days | Reduction of the size of the CSDH on CT scan of the head at 90-days from EMMA |
| Morbidity within 90-days | up to 90-days | peri-procedural morbidity related to EMMA such as puncture site hematoma, arterial dissection or stroke |
| 90-day MOCA and EQ-5D-5L health score | Day 90 | score on the Montreal Cognitive Assessment test and score on the EQ-5D-5L assessment |
| Discharge destination | up to 100 weeks | discharge location from acute care |
| Length of hospital stay | up to 100 weeks | number of days of acute care hospitalization |
Countries
Canada
Contacts
CONTACTJai Shankar, MD
CONTACTSusan Alcock, RN
PRINCIPAL_INVESTIGATORJai Shankar, MD
University of Manitoba
Outcome results
None listed