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

Brain Injuries, Traumatic Clinical Trial

— MOBI-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04893837
• Other study ID #: IRB-300007257
• Status: Recruiting
• Start date: April 18, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: Karen N Brown, MSHA
• Phone: 205-975-2393
• Email: karenbrown[@]uabmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

Device:
• Standard care plus infrascans
Hourly infrascans to detect expanding intracranial hematomas

Locations

Country	Name	City	State
United States	UAB Hospital	Birmingham	Alabama
United States	University of Arizona	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	InfraScan, Inc., United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of the infrascanner	Number of participants whose Infrascan results were accurate	Month 24
Secondary	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