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

Subdural Hematoma Clinical Trial

— EMMA-Can  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923984
• Other study ID #: HS24152(B2020-077)
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: University of Manitoba
• Contact: Jai Shankar, MD
• Phone: 4313734164
• Email: shivajai1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematoma
• Subdural Hematoma

Intervention

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

Locations

Country	Name	City	State
Canada	Health Sciences centre	Winnipeg MB	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subdural Hematoma recurrence at 3 months	Recurrence of SDH on CT scan of head within 3 months from EMMA.	3 months
Secondary	Size	Change in size of the CSDH	1 month and 3 months
Secondary	Mortality	Peri-procedural morbidity and mortality related to EMMA.	1month, 3months, 6months