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

University of Alabama at Birmingham399 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

399

Conditions

Brain Injuries, Traumatic

Interventions

Standard care plus infrascansDEVICE

Hourly infrascans to detect expanding intracranial hematomas

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Locations (2)

UAB Hospital

Birmingham, Alabama, United States

University of Arizona

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Diagnostic performance of the infrascanner

Number of participants whose Infrascan results were accurate

Time frame: Month 24

Secondary Outcomes

Time to detection of an enlarging hematoma

Difference in time to detection of hematoma enlargement between Infrascan and second CT across the cohort

Time frame: 0-12 hours

Data from ClinicalTrials.gov

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