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

Chronic Subdural Hematoma Clinical Trial

— EMMA-Can  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04750200
• Other study ID #: HS24435 (B2020:120)
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Manitoba
• Contact: Jai Shankar, MD
• Phone: 1-431-373-4164
• Email: shivajai1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Modified Rankin Scale of =2 at baseline

2. Patients requiring surgery or has at least 10 mm of CSDH on CT head and has one or more symptoms attributable to CSDH, including headache, cognitive impairment, ataxia, seizure, focal neurologic deficit, or decreased consciousness.

3. CT Angiogram of head and neck which favors vascular access for EMMA and lacks dangerous anatomic variations.

Exclusion Criteria:

1. If informed consent can not be obtained from the patients or their substitute decision makers.

2. CT Angiogram showing dangerous communication between middle meningeal artery and branches of internal carotid arteries.

3. Contraindication to the embolization procedure such as severe renal dysfunction, or pregnancy

4. Life expectancy < 6 months.

5. Known allergy to embolic agent

6. Acute subdural hematoma with homogenous hyperdensity on CT scan.

7. Secondary CSDH that may likely be due to the underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or prior craniotomy.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Embolization of the Middle Meningeal Artery
EMMA is performed inside of the blood vessels where tiny catheters are used to deliver polymer embolic agents to block small blood vessels supplying the brain coverings. A particulate polymer embolic agent (also called polyvinyl acrylate, PVA) or a liquid embolic agents (polymers of ethynyl vinyl alcohol, EVOH) can be used.

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	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	Chronic Subdural Hematoma (CSDH) recurrence at 90-days	Recurrence of the size of the CSDH on CT scan of head within 90-days from EMMA	90-days
Secondary	Mortality	Peri-procedural morbidity and mortality related to EMMA.	1 day of Discharge, 30-days, and 90-days
Secondary	Reduction of CSDH size at 90-days	Reduction of the size of the CSDH on CT scan of the head at 90 days from EMMA.	90-days