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

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ClinicalTrials.gov Identifier: NCT04750200
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
Jai Shankar, University of Manitoba

Study Description
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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).

Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Procedure: Embolization of the Middle Meningeal Artery Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open-label randomized control trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Chronic Subdural Hematoma With or Without Embolization of Middle Meningeal Artery in Canada (EMMA-Can)- A Randomized Control Trial.
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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Arm Intervention/treatment
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.
 Procedure: Embolization of the Middle Meningeal Artery
EMMA is performed inside of the blood vessels where tiny catheters are used to deliver polymer embolic agents to block small blood vessels supplying the brain coverings. A particulate polymer embolic agent (also called polyvinyl acrylate, PVA) or a liquid embolic agents (polymers of ethynyl vinyl alcohol, EVOH) can be used.


Outcome Measures
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Primary Outcome Measures :
  1. Chronic Subdural Hematoma (CSDH) recurrence at 90-days [ Time Frame: 90-days ]
    Recurrence of the size of the CSDH on CT scan of head within 90-days from EMMA


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 1 day of Discharge, 30-days, and 90-days ]
    Peri-procedural morbidity and mortality related to EMMA.

  2. Reduction of CSDH size at 90-days [ Time Frame: 90-days ]
    Reduction of the size of the CSDH on CT scan of the head at 90 days from EMMA.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750200


Contacts
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Contact: Jai Shankar, MD 1-431-373-4164 shivajai1@gmail.com
Contact: Susan Alcock, RN 1-204-789-3996 salcock@hsc.mb.ca

Locations
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Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 3P5
Contact: Jai Shankar, MD    431 373 4164    jshankar@hsc.mb.ca   
Contact: Susan Alcock, MN    204 789 3996    salcock@hsc.mb.ca   
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Jai JS Shankar, MD University of Manitoba
More Information
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Responsible Party: Jai Shankar, Professor, Department of Radiology, Neuro-Interventional Radiologist, University of Manitoba
ClinicalTrials.gov Identifier: NCT04750200    
Other Study ID Numbers: HS24435 (B2020:120)
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jai Shankar, University of Manitoba:
chronic subdural hematoma, Middle Meningeal embolization
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries