CompletedNot Applicable

Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)

United States399 participantsStarted 2022-04-18

Plain-language summary

MOBI-1 is a multicenter clinical trial that will evaluate the use of the Infrascanner for the monitoring of traumatic intracranial hematomas.

Age range15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Diagnostic performance of the infrascanner

Timeframe: Month 24

NCT IDNCT04893837

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-17