Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada (EMMA Can)

Overview

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.

Full Title of Study: “Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada -EMMA-Can”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2022

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.

Interventions

  • Procedure: Embolization of the middle meningeal artery
    • embolization of the middle meningeal artery with an embolic agent.

Arms, Groups and Cohorts

  • Experimental: Embolization of Middle Meningeal Artery for Subdural Hematoma
    • All patients with CSDH will undergo embolization of Middle Meningeal artery

Clinical Trial Outcome Measures

Primary Measures

  • Subdural Hematoma recurrence at 3 months
    • Time Frame: 3 months
    • Recurrence of SDH on CT scan of head within 3 months from EMMA.

Secondary Measures

  • Size
    • Time Frame: 1 month and 3 months
    • Change in size of the CSDH
  • Mortality
    • Time Frame: 1month, 3months, 6months
    • Peri-procedural morbidity and mortality related to EMMA.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Manitoba
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jai Shankar, Professor – University of Manitoba
  • Overall Official(s)
    • Jai Shankar, MD, Principal Investigator, University of Manitoba
  • Overall Contact(s)
    • Jai Shankar, MD, 4313734164, shivajai1@gmail.com

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