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

Not Applicable

Recruiting

• Conditions: Subdural Hematoma
• Interventions: Procedure: Embolization of the middle meningeal artery

• Registration Number: NCT04923984
• Lead Sponsor: University of Manitoba

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.

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Embolization of Middle Meningeal Artery for Subdural Hematoma	Embolization of the middle meningeal artery	All patients with CSDH will undergo embolization of Middle Meningeal artery

Primary Outcome Measures

Name	Time	Method
Subdural Hematoma recurrence at 3 months	3 months	Recurrence of SDH on CT scan of head within 3 months from EMMA.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Health Sciences centre; 🇨🇦 Winnipeg MB, Manitoba, Canada