Monitoring traumatic brain injuries with the Infrascanner
Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)
This study is testing if the Infrascanner can help doctors quickly spot changes in brain bleeding for patients aged 15 and older who have traumatic brain injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 440 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT04893837 on ClinicalTrials.gov |
What this trial studies
MOBI-1 is a multicenter observational study that evaluates the effectiveness of the Infrascanner in monitoring traumatic intracranial hematomas. Patients aged 15 and older with intracranial hemorrhage will receive standard care along with hourly assessments using the Infrascanner. The study aims to determine if this non-invasive tool can detect the expansion of hematomas more quickly than standard monitoring methods. Data collected will be relayed to the medical team to enhance patient care.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 15 or older who have been admitted with an intracranial hemorrhage and a Glasgow Coma Scale score of less than 15.
Not a fit: Patients who have already received extensive neurological checks or have non-survivable injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster identification and management of expanding intracranial hematomas in patients with traumatic brain injuries.
How similar studies have performed: While the use of non-invasive monitoring tools is gaining traction, this specific application of the Infrascanner for traumatic brain injuries is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 1 other locations
- UAB Hospital — Birmingham, Alabama, United States (Recruiting)
- University of Arizona — Tucson, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Jan O Jansen, MBBS, PhD — University of Alabama at Birmingham, Center for Injury Science
- Study coordinator: Karen N Brown, MSHA
- Email: karenbrown@uabmc.edu
- Phone: 205-975-2393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.