Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04923984

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

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 CSDH with or without concomitant surgical evacuation.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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, 6 and 12 months interval. The follow up at 3 months will include plain CT head of the patient, which is standard of care for most patients. The follow up at 6 and 12 months will be only clinical follow up.

Patients will be assessed for recurrence of CSDH on CT scan of head. Symptoms associated with the recurrence will be recorded. 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 3 months post EMMA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic.

Exclusion criteria

  • If informed consent cannot be obtained from the patient or their substitute decision maker.
  • Known allergy to liquid embolic agent

Treatment and study plan

Embolization of the middle meningeal artery

Procedure

embolization of the middle meningeal artery with an embolic agent (Microparticles, liquid embolic agents, SwiftPAC coils or others).

Primary outcomes

  1. Radiographic recurrence

    Time frame: up to 90-days for EMMA

    Recurrence of CSDH on imaging (CT scan or MRI) of head .

  2. Symptomatic recurrence

    Time frame: up to 90-days from EMMA

    Symptomatic recurrence attributable to the side of the CSDH on imaging (CT scan or MRI) of head

Secondary outcomes

  1. Size

    Time frame: 30 days and 90 days

    Change in size of the CSDH

  2. Mortality within 90-days

    Time frame: up to 90-days

    Peri-procedural mortality related to EMMA.

  3. 90 day Modified Rankin Score </=3

    Time frame: 90-days

    Percentage of patients with a Modified Rankin score </=3

  4. Reduction of CSDH size at 90-days

    Time frame: 90-days

    Reduction of the size of the CSDH on CT scan of the head at 90-days from EMMA

  5. Morbidity within 90-days

    Time frame: up to 90-days

    peri-procedural morbidity related to EMMA such as puncture site hematoma, arterial dissection or stroke

  6. 90-day MOCA and EQ-5D-5L health score

    Time frame: Day 90

    score on the Montreal Cognitive Assessment test and score on the EQ-5D-5L assessment

  7. Discharge destination

    Time frame: up to 100 weeks

    discharge location from acute care

  8. Length of hospital stay

    Time frame: up to 100 weeks

    number of days of acute care hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Jai Shankar, MD

CONTACT

[email protected]

4313734164

Susan Alcock, RN

CONTACT

[email protected]

2047893669

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Acronym: EMMA-Can

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Jun 11, 2021
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.