Management of CSDH With or Without EMMA- a Randomized Control Trial — EMMA-Can  

Chronic Subdural Hematoma Clinical Trial

Official title: Management of Chronic Subdural Hematoma With or Without Embolization of Middle Meningeal Artery in Canada (EMMA-Can)- A Randomized Control Trial.

Status Recruiting

Clinical Trial Summary

EMMA-Can is an open-label randomized control trial comparing the recurrence risk in patients with chronic subdural hematoma (CSDH) undergoing standard of care treatment (surgical drainage and/or medical management) with or without embolization of the middle meningeal (EMMA).

Clinical Trial Description

All patients in clinical need of surgical drainage or medical management for the CSDH will be randomized in our study. Patients that present in the Emergency Department (ED) or neurosurgery clinic will be assessed for standard of care treatment options based on their presenting symptoms; this may include surgical drainage or medical management. Patients will then by screened for study eligibility based on the study inclusion and exclusion criteria. After screening and consenting patients will be randomized in to the control arm or interventional arm.

Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage and/or medical management) of the CSDH.

Patients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage and/or medical management) of the CSDH as per the standard of care in the institution. These patients will then undergo EMMA within 48 hours after finishing the surgical drainage. The embolic agent and use of general anaesthesia versus conscious sedation will be left to operators' preference and the institutional protocol.

All patients will be followed as per the institutional standard of the care. Any peri-procedural complications and change in clinical status will be recorded. The risk of recurrence at 90-days in patients who undergo standard of care treatment (surgical and/or medical management) of CSDH with or without EMMA will be observed. ;

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

• NCT number: NCT04750200
• Study type: Interventional
• Source: University of Manitoba
• Contact: Jai Shankar, MD
• Phone: 1-431-373-4164
• Email: shivajai1@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Completion date: December 31, 2025