Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada (EMMA Can) (EMMA-Can)
Primary Purpose
Subdural Hematoma
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Embolization of the middle meningeal artery
Sponsored by
About this trial
This is an interventional diagnostic trial for Subdural Hematoma focused on measuring Embolization, Middle Meningeal Artery, Chronic Subdural Hematoma
Eligibility Criteria
Inclusion Criteria:
- All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic
Exclusion Criteria:
- When informed consent is not possible
- Known allergy to liquid embolic agent
Sites / Locations
- Health Sciences centreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Embolization of Middle Meningeal Artery for Subdural Hematoma
Arm Description
All patients with CSDH will undergo embolization of Middle Meningeal artery
Outcomes
Primary Outcome Measures
Subdural Hematoma recurrence at 3 months
Recurrence of SDH on CT scan of head within 3 months from EMMA.
Secondary Outcome Measures
Size
Change in size of the CSDH
Mortality
Peri-procedural morbidity and mortality related to EMMA.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04923984
Brief Title
Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada (EMMA Can)
Acronym
EMMA-Can
Official Title
Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada -EMMA-Can
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (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
No
5. Study Description
Brief Summary
EMMA-Can is a prospective cohort study to assess the safety and effectiveness of MMA-embolization for the treatment of CSDH.
Hypothesis- EMMA reduces the recurrence rate of SDH with or without concomitant surgical evacuation.
Detailed Description
The purpose of our study is to conduct a prospective cohort study to assess the safety and effectiveness of MMA embolization for the treatment of CSDH. All patients with CSDH presenting to the emergency room or to neurosurgical outpatient clinic will be screened for potential enrollment. If the subject is willing to participate an informed consent will be obtained.
All patients presenting to the emergency room or in neurosurgery clinic with CSDH diagnosed on CT scan will be considered for the study. If the patient needs emergent evacuation for clinical reasons, patient will be taken for surgical evacuation before consideration of EMMA. Patients that are more likely to have recurrence after surgical evacuation are those with recurrent CSDH, on antiplatelet or antithrombotic treatment. The EMMA could be used as primary treatment or in conjunction with surgery in these patients or in patients who may not be good surgical candidate.
Follow up - All patients will be followed after discharge from the hospital at 1, 3 and 6 months interval. The follow up at 1 and 3 months will include plain CT head of the patient, which is standard of care for most patients. The follow up at 6 months will be only clinical follow up.
Patients will be assessed for recurrence of CSDH on CT scan of head. The size of the CSDH will be measured and compared to previous scans and peri-procedural morbidity and mortality related to EMMA will be sought. This will be done at 1 and 3 months post EMMA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subdural Hematoma
Keywords
Embolization, Middle Meningeal Artery, Chronic Subdural Hematoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Embolization of Middle Meningeal Artery for Subdural Hematoma
Arm Type
Experimental
Arm Description
All patients with CSDH will undergo embolization of Middle Meningeal artery
Intervention Type
Procedure
Intervention Name(s)
Embolization of the middle meningeal artery
Intervention Description
embolization of the middle meningeal artery with an embolic agent.
Primary Outcome Measure Information:
Title
Subdural Hematoma recurrence at 3 months
Description
Recurrence of SDH on CT scan of head within 3 months from EMMA.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Size
Description
Change in size of the CSDH
Time Frame
1 month and 3 months
Title
Mortality
Description
Peri-procedural morbidity and mortality related to EMMA.
Time Frame
1month, 3months, 6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic
Exclusion Criteria:
When informed consent is not possible
Known allergy to liquid embolic agent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jai Shankar, MD
Phone
4313734164
Email
shivajai1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Alcock, RN
Phone
2047893669
Email
salcock@hsc.mb.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jai Shankar, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences centre
City
Winnipeg MB
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jai Shankar, MD FRCPC
Phone
431 373 4164
Email
shivajai1@gmail.com
First Name & Middle Initial & Last Name & Degree
Susan Alcock
Phone
204 789 3996
Email
salcock@hsc.mb.ca
First Name & Middle Initial & Last Name & Degree
Jai Shankar, MD FRCPC
12. IPD Sharing Statement
Learn more about this trial
Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada (EMMA Can)
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