Clinical trial NCT04750200: Management of CSDH With or Without EMMA- a Randomized Control Trial
Official title: Management of Chronic Subdural Hematoma With or Without Embolization of Middle Meningeal Artery in Canada (EMMA-Can)- A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: chronic subdural hematoma, Middle Meningeal embolization
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open-label randomized control trial
Primary purpose: TREATMENT

Brief 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).

Detailed description: All patients in clinical need of surgical drainage or medical management for the CSDH will be randomized in our study. Patients that present in the Emergency Department (ED) or neurosurgery clinic will be assessed for standard of care treatment options based on their presenting symptoms; this may include surgical drainage or medical management. Patients will then by screened for study eligibility based on the study inclusion and exclusion criteria. After screening and consenting patients will be randomized in to the control arm or interventional arm.

Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage and/or medical management) of the CSDH.

Patients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage and/or medical management) of 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 anaesthesia versus 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. The risk of recurrence at 90-days in patients who undergo standard of care treatment (surgical and/or medical management) of CSDH with or without EMMA will be observed.

Eligibility criteria: Inclusion Criteria:

1. Modified Rankin Scale of ≤2 at baseline
2. 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.
3. CT Angiogram of head and neck which favors vascular access for EMMA and lacks dangerous anatomic variations.

Exclusion Criteria:

1. If informed consent can not be obtained from the patients or their substitute decision makers.
2. CT Angiogram showing dangerous communication between middle meningeal artery and branches of internal carotid arteries.
3. Contraindication to the embolization procedure such as severe renal dysfunction, or pregnancy
4. Life expectancy \< 6 months.
5. Known allergy to embolic agent
6. Acute subdural hematoma with homogenous hyperdensity on CT scan.
7. 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.

Primary outcomes:
measure: Chronic Subdural Hematoma (CSDH) recurrence at 90-days
timeFrame: 90-days
Secondary outcomes:
measure: Mortality
timeFrame: 1 day of Discharge, 30-days, and 90-days
measure: Reduction of CSDH size at 90-days
timeFrame: 90-days
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Jai JS Shankar, MD
role: PRINCIPAL_INVESTIGATOR
References: