Health Sciences centre
Winnipeg MB, Manitoba, R3A 1R9, Canada
Location status: Recruiting
Location contact
Jai Shankar, MD FRCPC
CONTACT
Jai Shankar, MD FRCPC
PRINCIPAL_INVESTIGATOR
Susan Alcock
CONTACT
NCT Number: NCT04923984
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Winnipeg MB, Manitoba, R3A 1R9, Canada
Location status: Recruiting
Jai Shankar, MD FRCPC
CONTACT
Jai Shankar, MD FRCPC
PRINCIPAL_INVESTIGATOR
Susan Alcock
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
embolization of the middle meningeal artery with an embolic agent (Microparticles, liquid embolic agents, SwiftPAC coils or others).
Time frame: up to 90-days for EMMA
Recurrence of CSDH on imaging (CT scan or MRI) of head .
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
Time frame: 30 days and 90 days
Change in size of the CSDH
Time frame: up to 90-days
Peri-procedural mortality related to EMMA.
Time frame: 90-days
Percentage of patients with a Modified Rankin score </=3
Time frame: 90-days
Reduction of the size of the CSDH on CT scan of the head at 90-days from EMMA
Time frame: up to 90-days
peri-procedural morbidity related to EMMA such as puncture site hematoma, arterial dissection or stroke
Time frame: Day 90
score on the Montreal Cognitive Assessment test and score on the EQ-5D-5L assessment
Time frame: up to 100 weeks
discharge location from acute care
Time frame: up to 100 weeks
number of days of acute care hospitalization
Contact information is provided by the study sponsor or research team.
Jai Shankar, MD
CONTACT
Susan Alcock, RN
CONTACT
University of Manitoba
Other
Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada -EMMA-Can
Acronym: EMMA-Can
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.
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