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Clinical Trial Summary

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 SDH with or without concomitant surgical evacuation.


Clinical Trial Description

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 and 6 months interval. The follow up at 1 and 3 months will include plain CT head of the patient, which is standard of care for most patients. The follow up at 6 months will be only clinical follow up. Patients will be assessed for recurrence of CSDH on CT scan of head. 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 1 and 3 months post EMMA. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04923984
Study type Interventional
Source University of Manitoba
Contact Jai Shankar, MD
Phone 4313734164
Email shivajai1@gmail.com
Status Recruiting
Phase N/A
Start date May 1, 2021
Completion date December 1, 2024

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