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

Recruiting

• Conditions: Brain Injuries, Traumatic
• Interventions: Device: Standard care plus infrascans

• Registration Number: NCT04893837
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-14
• Study First Submitted QC: 2021-05-14
• Study First Posted: 2021-05-20
• Study Start: 2022-04-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard care plus infrascans	Standard care plus infrascans	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of the infrascanner	Month 24	Number of participants whose Infrascan results were accurate

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

UAB Hospital; 🇺🇸 Birmingham, Alabama, United States