Health TrialsbyHealthPanel

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

ConditionSubdural Hematoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

If informed consent cannot be obtained from the patient or their substitute decision maker.

Known allergy to liquid embolic agent

Trial design

Design model

Single group

Treatments tested in this trial

  • Embolization of the middle meningeal artery

    Procedure/Surgery

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

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Embolization of Middle Meningeal Artery for Subdural HematomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Radiographic recurrence

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

Time frame
up to 90-days for EMMA
2

Symptomatic recurrence

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

Time frame
up to 90-days from EMMA

Secondary outcomes

1

Size

Change in size of the CSDH

Time frame
30 days and 90 days
2

Mortality within 90-days

Peri-procedural mortality related to EMMA.

Time frame
up to 90-days
3

90 day Modified Rankin Score </=3

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

Time frame
90-days
4

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

Time frame
90-days

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Health Sciences centreRecruitingR3A 1R9, Winnipeg MB, ManitobaCanadaCanada

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manitoba

Lead sponsor

Source ClinicalTrials.gov
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