Brain Injuries, Traumatic
Conditions
Keywords
traumatic brain injury, TBI, intracranial hematoma, ICH
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 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.
Interventions
DEVICEStandard care plus infrascans
Hourly infrascans to detect expanding intracranial hematomas
Sponsors
United States Department of Defense
InfraScan, Inc.
University of Alabama at Birmingham
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of the infrascanner | Month 24 | Number of participants whose Infrascan results were accurate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to detection of an enlarging hematoma | 0-12 hours | Difference in time to detection of hematoma enlargement between Infrascan and second CT across the cohort |
Countries
United States
Outcome results
None listed