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

NCT04750200 | Active Not Recruiting DMC

• 1 other identifier: HS24435 (B2020:120)
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

EMMA-Can is a prospective randomized open-label, blinded end point (PROBE) study, that will assess the recurrence risk and safety of embolization of the middle meningeal (EMMA) when added to standard of care treatment (surgical drainage) of chronic subdural hematoma (CSDH) compared to surgical treatment alone.

Conditions

Chronic Subdural Hematoma

Keywords

chronic subdural hematoma, Embolization of Middle Meningeal artery (EMMA)

Outcome Measures

Primary Outcomes (1)

• Chronic Subdural Hematoma (CSDH) recurrence at 90-days on CT scan

  Symptomatic recurrence of the CSDH on CT scan of head within 90-days from EMMA

  90-days

Secondary Outcomes (7)

• 90 day mRs ≤3

  90-days

• Reduction of CSDH size at 90-days

  90-days

• Mortality within 90-days

  "up to 90-days"

• Morbidity within 90-days

  " up to 90-days"

• 90-day MOCA and EQ-5D-5L health score

  " Day 90"

Study Arms (2)

Control Arm

NO INTERVENTION

Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage) for the CSDH.

Interventional Arm

EXPERIMENTAL

Patients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage) for the CSDH followed by EMMA within 72 hours of surgical drainage. The embolization will be done using a liquid embolic agent (Onyx) and will be done under a general anesthesia or conscious sedation as per the operator's preference. 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.

Procedure: Embolization of the Middle Meningeal Artery

Interventions

Embolization of the Middle Meningeal Artery PROCEDURE

EMMA is performed inside of the blood vessels where tiny catheters are used to deliver a liquid embolic agent (Onyx) to block small blood vessels supplying the brain coverings.

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Premorbid Modified Rankin Scale of ≤2;
• Patients with unilateral symptomatic primary or recurrent CSDH \>10 mm in thickness on CT head undergoing surgical drainage;
• CT Angiogram of head and neck which favors vascular access for EMMA and lacks dangerous anatomic variations;
• Patients over 18 years of age; no upper age limit.

You may not qualify if:

• If informed consent cannot be obtained from the patients or their substitute decision makers;
• Patients with bilateral symptomatic CSDH;
• CTA showing persistent communication between branches of middle meningeal artery and that of internal carotid arteries;
• Contraindication to the embolization procedure such as severe renal dysfunction (eGFR\<30), or pregnancy;
• Life expectancy \< 6 months;
• Known allergy to Onyx;
• Acute subdural hematoma with homogenous hyperdensity on CT scan;
• 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;
• Patients needing treatment with 2 weeks of dexamethasone or tranexamic acid will be contraindicated in the study patients to avoid confounding.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 3P5, Canada

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Jai JS Shankar, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Radiology, Neuro-Interventional Radiologist

Model Details: open-label randomized control trial

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 11, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)