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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04893837
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : July 8, 2022
Sponsor:
Collaborators:
United States Department of Defense
InfraScan, Inc.
Information provided by (Responsible Party):
Jan O. Jansen, University of Alabama at Birmingham

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

Condition or disease Intervention/treatment
Brain Injuries, Traumatic Device: Standard care plus infrascans

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 440 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)
Actual Study Start Date : April 18, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.

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


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic performance of the infrascanner [ Time Frame: Month 24 ]
    Number of participants whose Infrascan results were accurate


Secondary Outcome Measures :
  1. Time to detection of an enlarging hematoma [ Time Frame: 0-12 hours ]
    Difference in time to detection of hematoma enlargement between Infrascan and second CT across the cohort


Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04893837


Contacts
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Contact: Karen N Brown, MSHA 205-975-2393 karenbrown@uabmc.edu
Contact: Shannon W Stephens, CCEMPT 205-934-5890 swstephens@uabmc.edu

Locations
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United States, Alabama
UAB Hospital Recruiting
Birmingham, Alabama, United States, 35233
Contact: Jan O Jansen, MBBS, PhD    205-975-2393    jjansen@uabmc.edu   
Contact: Shannon W Stephens    205-934-5890    swstephens@uabmc.edu   
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Bellal Joseph, MD    520-626-5056    bjoseph@surgery.arizona.edu   
Contact: Robin Carlson, PhD    520-626-2876    rscarlson@email.arizona.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
United States Department of Defense
InfraScan, Inc.
Investigators
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Principal Investigator: Jan O Jansen, MBBS, PhD University of Alabama at Birmingham, Center for Injury Science
More Information
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Responsible Party: Jan O. Jansen, Associate Professor and Director, UAB Center for Injury Science, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04893837    
Other Study ID Numbers: IRB-300007257
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This data will be uploaded to the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system, as a requirement of the funding agency. Only de-identified data will be shared.
Time Frame: Data will be uploaded to FITBIR annually.
Access Criteria: Access is through the FITBIR system, per their requirements.
URL: https://fitbir.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jan O. Jansen, University of Alabama at Birmingham:
traumatic brain injury, TBI, intracranial hematoma, ICH
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System