Management of CSDH With or Without EMMA- a Randomized Control Trial

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    200
  • sponsor
    University of Manitoba
Updated on 1 October 2021

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).

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.

Details
Condition Chronic subdural hematoma
Treatment Embolization of the Middle Meningeal Artery
Clinical Study IdentifierNCT04750200
SponsorUniversity of Manitoba
Last Modified on1 October 2021

Eligibility

Yes No Not Sure

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
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