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

The University of Alabama at Birmingham

Status: Completed

Conditions: Brain Injuries, Traumatic

Treatments: Device: Standard care plus infrascans

Study type: Observational

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT04893837

20-15-TBI-008 (Other Grant/Funding Number)

IRB-300007257

Details and patient eligibility

About

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

Full 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.

Enrollment: 399 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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 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 received second neurological check)
3. Other injuries deemed non-survivable
4. Diagnosed with hemorrhagic shock or receives a large volume transfusion (>3 units of any blood product within any 1 hour)
5. Planned surgical interventions/ procedures during study period (before the second CT scan)
6. Known prisoner

Trial design

399 participants in 1 patient group

Standard care plus infrascans

Description:

All participants will receive regular clinical neurological assessments as ordered by the clinical care team. In addition, a research team member will perform an infrascan. This process will be repeated hourly at the same timepoint as the clinical neurological assessments. If a patient's neurological status deteriorates at any time point, and the medical team orders an early (unplanned) CT scan, the neurological data collection will cease once the patient is sent to CT. Infrascan results will not be shared with the clinical care team, and will not guide the participants' care in any way.

Treatment:

Device: Standard care plus infrascans