Management of Chronic Subdural Hematoma With or Without Embolization of Middle Meningeal Artery in Canada (EMMA-Can)- A Randomized Control Trial.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
EMMA-Can is an open-label randomized control trial comparing the recurrence risk in patients with chronic subdural hematoma (CSDH) undergoing standard of care treatment (surgical drainage and/or medical management) with or without embolization of the middle meningeal (EMMA).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Modified Rankin Scale of ≤2 at baseline
• Patients requiring surgery or has at least 10 mm of CSDH on CT head and has one or more symptoms attributable to CSDH, including headache, cognitive impairment, ataxia, seizure, focal neurologic deficit, or decreased consciousness.
• CT Angiogram of head and neck which favors vascular access for EMMA and lacks dangerous anatomic variations.
Locations
Other Locations
Canada
University of Manitoba
RECRUITING
Winnipeg
Contact Information
Primary
Jai Shankar, MD
shivajai1@gmail.com
1-431-373-4164
Backup
Susan Alcock, RN
salcock@hsc.mb.ca
1-204-789-3996
Time Frame
Start Date: 2021-08-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 200
Treatments
No_intervention: Control Arm
Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage and/or medical management for the CSDH.
Experimental: Interventional Arm
Patients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage and/or medical management for the CSDH as per the standard of care in the institution. These patients will then undergo EMMA within 48 hours after finishing the surgical drainage. The embolic agent and use of general anesthesia vs conscious sedation will be left to operators' preference and the institutional protocol. All patients will be followed as per the institutional standard of the care. Any peri-procedural complications and change in clinical status will be recorded.
Related Therapeutic Areas
Sponsors
Leads: University of Manitoba