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

Last updated: July 3, 2024
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

Standard care plus infrascans

Clinical Study ID

NCT04893837
IRB-300007257
  • Ages > 15
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 15 or older

  2. Admission CT Scan shows intracranial hemorrhage

  3. Glasgow Coma Scale less than 15

  4. Neurosurgery service determines initial care is nonoperative

  5. Admitted for observation for TBI, to either step-down unit or intensive care unit

Exclusion

Exclusion Criteria:

  1. Inability to provide informed consent or lack of a legally authorized representative (LAR)

  2. Admitted and observed for >2 hours prior to screening (i.e., has already receivedsecond neurological check)

  3. Other injuries deemed non-survivable

  4. Diagnosed with hemorrhagic shock or receives a large volume transfusion (>3 units ofany blood product within any 1 hour)

  5. Planned surgical interventions/ procedures during study period (before the second CTscan)

  6. Known prisoner

Study Design

Total Participants: 440
Treatment Group(s): 1
Primary Treatment: Standard care plus infrascans
Phase:
Study Start date:
April 18, 2022
Estimated Completion Date:
June 30, 2025

Study 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 care plus hourly infrascanner assessments. This study will test the hypotheses that:

  1. The Infrascanner has sufficient diagnostic performance to detect the expansion of intracranial hematomas

  2. Patients who have expanding intracranial hematomas will be identified faster when monitored with hourly infrascanner assessments compared to standard care alone

  3. Clinical / research staff will be able to attain all data points and relay the assessments to the medical team.

Connect with a study center

  • UAB Hospital

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of Arizona

    Tucson, Arizona 85724
    United States

    Active - Recruiting

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