Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923984
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2021-06-07
Brief Title:
Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada EMMA Can
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada -EMMA-Can
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMMA-Can
Brief 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
Hypothesis- EMMA reduces the recurrence rate of SDH with or without concomitant surgical evacuation
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None