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

Last updated: January 10, 2025
Sponsor: University of Manitoba
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Injury

Treatment

Embolization of the middle meningeal artery

Clinical Study ID

NCT04923984
HS24152(B2020-077)
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients with subdural hematoma coming to the emergency room or to neurosurgicaloutpatient clinic

Exclusion

Exclusion Criteria:

  • When informed consent is not possible

  • Known allergy to liquid embolic agent

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Embolization of the middle meningeal artery
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Health Sciences centre

    Winnipeg MB, Manitoba R3A 1R9
    Canada

    Active - Recruiting

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