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

Primary Purpose

Chronic Subdural Hematoma

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Embolization of the Middle Meningeal Artery
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring chronic subdural hematoma, Middle Meningeal embolization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of ManitobaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Arm

Interventional Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Chronic Subdural Hematoma (CSDH) recurrence at 90-days
Recurrence of the size of the CSDH on CT scan of head within 90-days from EMMA

Secondary Outcome Measures

Mortality
Peri-procedural morbidity and mortality related to EMMA.
Reduction of CSDH size at 90-days
Reduction of the size of the CSDH on CT scan of the head at 90 days from EMMA.

Full Information

First Posted
February 8, 2021
Last Updated
September 13, 2021
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT04750200
Brief Title
Management of CSDH With or Without EMMA- a Randomized Control Trial
Acronym
EMMA-Can
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
chronic subdural hematoma, Middle Meningeal embolization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
open-label randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage and/or medical management for the CSDH.
Arm Title
Interventional Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Embolization of the Middle Meningeal Artery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chronic Subdural Hematoma (CSDH) recurrence at 90-days
Description
Recurrence of the size of the CSDH on CT scan of head within 90-days from EMMA
Time Frame
90-days
Secondary Outcome Measure Information:
Title
Mortality
Description
Peri-procedural morbidity and mortality related to EMMA.
Time Frame
1 day of Discharge, 30-days, and 90-days
Title
Reduction of CSDH size at 90-days
Description
Reduction of the size of the CSDH on CT scan of the head at 90 days from EMMA.
Time Frame
90-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jai Shankar, MD
Phone
1-431-373-4164
Email
shivajai1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Alcock, RN
Phone
1-204-789-3996
Email
salcock@hsc.mb.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jai JS Shankar, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jai Shankar, MD
Phone
431 373 4164
Email
jshankar@hsc.mb.ca
First Name & Middle Initial & Last Name & Degree
Susan Alcock, MN
Phone
204 789 3996
Email
salcock@hsc.mb.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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

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