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

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

Detailed Description
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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: The Infrascanner has sufficient diagnostic performance to detect the expansion of intracranial hematomas Patients who have expanding intracranial hematomas will be identified faster when monitored with hourly infrascanner assessments compared to standard care alone Clinical / research staff will be able to attain all data points and relay the assessments to the medical team.

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

Conditions
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Brain Injuries, Traumatic

Intervention / Treatment
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* Device: Standard care plus infrascans


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard care plus infrascans<br>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. | Device: Standard care plus infrascans<br>* Hourly infrascans to detect expanding intracranial hematomas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of the infrascanner | Number of participants whose Infrascan results were accurate | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to detection of an enlarging hematoma | Difference in time to detection of hematoma enlargement between Infrascan and second CT across the cohort | 0-12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury, TBI, intracranial hematoma, ICH