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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Procedure: Embolization of the Middle Meningeal Artery

Detailed Description

All patients in clinical need of surgical drainage 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. 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 receive institutional standard of care treatment (surgical drainage) of the CSDH.

Patients randomized to the interventional arm will receive institutional standard of care treatment (surgical drainage) of the CSDH followed by EMMA, with Onyx and under a general anesthetic within 72 hours of surgical drainage.

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 will be assessed in all patients.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P5
      • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. If informed consent cannot be obtained from the patients or their substitute decision makers;
2. Patients with bilateral symptomatic CSDH;
3. CTA showing persistent communication between branches of middle meningeal artery and that of internal carotid arteries;
4. Contraindication to the embolization procedure such as severe renal dysfunction (eGFR<30), or pregnancy;
5. Life expectancy < 6 months;
6. Known allergy to Onyx;
7. Acute subdural hematoma with homogenous hyperdensity on CT scan;
8. 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;
9. Patients needing treatment with 2 weeks of dexamethasone or tranexamic acid will be contraindicated in the study patients to avoid confounding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage) for the CSDH.
Experimental: Interventional Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
90 day mRs ≤3	Percentage of patients with a Modified Rankin score ≤3.	90-days
Mortality within 90-days	Peri-procedural mortality related to EMMA	"up to 90-days"
Morbidity within 90-days	Peri-procedural morbidity related to EMMA such as, puncture site hematoma, arterial dissection or stroke	" up to 90-days"
90-day MOCA and EQ-5D-5L health score	Score on the Montreal Cognitive Assessment test and score on the EQ-5D-5L assessment	" Day 90"
Discharge destination	Discharge location from acute care	"Discharge Day"
Length of hospital stay	Number of days of acute care hospitalization	"Discharge Day"

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Jai JS Shankar, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: chronic subdural hematoma, Embolization of Middle Meningeal artery (EMMA)
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Pathological Conditions, Signs and Symptoms; Hematoma, Subdural; Hematoma; Hematoma, Subdural, Chronic
• Other Study ID Numbers: HS24435 (B2020:120)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No