NCT04923984

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 CSDH 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, 6 and 12 months interval. The follow up at 3 months will include plain CT head of the patient, which is standard of care for most patients. The follow up at 6 and 12 months will be only clinical follow up. Patients will be assessed for recurrence of CSDH on CT scan of head. Symptoms associated with the recurrence will be recorded. 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 3 months post EMMA.

Conditions

• Subdural Hematoma

Interventions

Type	Name	Description
PROCEDURE	Embolization of the middle meningeal artery	embolization of the middle meningeal artery with an embolic agent (Microparticles, liquid embolic agents, SwiftPAC coils or others).

Timeline

• Start date: 2021-05-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2021-06-11
• Last updated: 2026-02-03

Locations

1 site across 1 country: Canada