Status:
COMPLETED
Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
United States Department of Defense
InfraScan, Inc.
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
15+ years
Brief Summary
MOBI-1 is a multicenter clinical trial that will evaluate the use of the Infrascanner for the monitoring of traumatic intracranial hematomas.
Detailed Description
MOBI-1 is a single-arm, multi-center derivation / validation study that will evaluate the use of the Infrascanner for monitoring traumatic intracranial hematomas. All patients will receive standard ca...
Eligibility Criteria
Inclusion
- Age 15 or older
- Admission CT Scan shows intracranial hemorrhage
- Glasgow Coma Scale less than 15
- Neurosurgery service determines initial care is nonoperative
- Admitted for observation for TBI, to either step-down unit or intensive care unit
Exclusion
- Inability to provide informed consent or lack of a legally authorized representative (LAR)
- Admitted and observed for \>2 hours prior to screening (i.e., has already received second neurological check)
- Other injuries deemed non-survivable
- Diagnosed with hemorrhagic shock or receives a large volume transfusion (\>3 units of any blood product within any 1 hour)
- Planned surgical interventions/ procedures during study period (before the second CT scan)
- Known prisoner
Key Trial Info
Start Date :
April 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 25 2025
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT04893837
Start Date
April 18 2022
End Date
August 25 2025
Last Update
September 2 2025
Active Locations (2)
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1
UAB Hospital
Birmingham, Alabama, United States, 35233
2
University of Arizona
Tucson, Arizona, United States, 85724