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Search / Trial NCT04893837

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

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · May 14, 2021

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Traumatic Brain Injury, Tbi, Intracranial Hematoma, Ich

ClinConnect Summary

The MOBI-1 trial is a research study looking at how well the Infrascanner, a non-invasive device, can help monitor patients with brain injuries, specifically those who have bleeding inside the skull (intracranial hematomas). This study is currently recruiting participants who are 15 years or older, have a CT scan showing brain bleeding, and have a Glasgow Coma Scale score of less than 15, which means they may have some level of consciousness impairment. Participants must also be receiving non-surgical care and be admitted for observation in a step-down unit or intensive care unit.

If you or a family member qualify for this study, you can expect to be closely monitored using the Infrascanner without the need for any invasive procedures. The goal is to see if this device can accurately track the progress of brain injuries over time. It's important to note that individuals who cannot provide consent, have been in the hospital for more than two hours before screening, or have other serious health issues may not be eligible to participate. This study aims to improve how we monitor and treat patients with traumatic brain injuries, ultimately helping healthcare providers make better decisions about patient care.

Gender

ALL

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

About University Of Alabama At Birmingham

The University of Alabama at Birmingham (UAB) is a prominent academic institution and research hub dedicated to advancing healthcare through innovative clinical trials. Renowned for its commitment to medical discovery and education, UAB conducts cutting-edge research across a wide array of disciplines, including oncology, cardiology, neurology, and public health. With a robust infrastructure for clinical research, UAB fosters collaboration among interdisciplinary teams, leveraging state-of-the-art facilities and resources to enhance the translation of scientific findings into effective treatments and interventions. As a leader in clinical research, UAB aims to improve patient outcomes and contribute to the broader medical community through rigorous trial design and implementation.

Locations

Tucson, Arizona, United States

Birmingham, Alabama, United States

Patients applied

0 patients applied

Trial Officials

Jan O Jansen, MBBS, PhD

Principal Investigator

University of Alabama at Birmingham, Center for Injury Science

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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