Management of CSDH With or Without EMMA- a Randomized Control Trial (EMMA-Can)
Chronic Subdural Hematoma
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring chronic subdural hematoma, Middle Meningeal embolization
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- If informed consent can not be obtained from the patients or their substitute decision makers.
- CT Angiogram showing dangerous communication between middle meningeal artery and branches of internal carotid arteries.
- Contraindication to the embolization procedure such as severe renal dysfunction, or pregnancy
- Life expectancy < 6 months.
- Known allergy to embolic agent
- Acute subdural hematoma with homogenous hyperdensity on CT scan.
- Secondary CSDH that may likely be due to the underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or prior craniotomy.
Sites / Locations
- University of ManitobaRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control Arm
Interventional Arm
Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage and/or medical management for the CSDH.
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.