Clinical trial NCT04893837: Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)
Official title: Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Injuries, Traumatic
Keywords: traumatic brain injury, TBI, intracranial hematoma, ICH
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: InfraScan, Inc.
First posted: 2021-05-20
Enrollment: 440
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will enroll up to 440 patients over 14 months, at 10 trauma centers. Currently, there are no high quality published datasets or literature to document the mean or variability in time to the detection of hematoma expansion that could be used for meaningful sample size projections. Therefore, this study has been designed to provide reasonable estimates of the future study outcomes.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic performance of the infrascanner
timeFrame: Month 24
Secondary outcomes:
measure: Time to detection of an enlarging hematoma
timeFrame: 0-12 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Alabama at Birmingham, Center for Injury Science
name: Jan O Jansen, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: