Evaluation of the Abbott i-STAT TBI Biomarker Test

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06766435
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • i-STAT TBI Test — DEVICE
    The Abbott i-STAT TBI test result is shared with the enrolled patient and treating clinicians.

Study Details

According to the Centers for Disease Control and Prevention, approximately 200,000 hospitalizations occurred in 2020 related to Traumatic Brain Injury (TBI), which does not include many TBIs treated only in emergency departments, urgent care, primary care, or that are not evaluated by a clinician. Head CT is a critical component of care for severe TBI, however in mild TBI there is practice variation with a wider risk to benefit estimation for obtaining head CT imaging. Potential disadvantages of head CT include longer Emergency Department (ED) length of stay (LOS), higher costs, and diagnostic radiation exposure. The i-STAT TBI test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in whole blood and a semi-quantitative interpretation of test results derived from these measurements, using the i-STAT Alinity instrument. This biomarker test is cleared for use in adults with mild TBI (Glasgow Coma Scale 13-15) within 24 hours of injury, to aid in determining the need for head CT imaging. Currently, CT head imaging for adults with suspected mild TBI is obtained based on clinicians' usual practice patterns and beliefs about patient expectations. Prior research has demonstrated the blood TBI test may reduce unnecessary CT scans by up to 40%, however the impact on head CT ordering has not yet been studied prospectively. It is important to understand the extent to which a negative TBI biomarker result empowers a clinician to cancel a previously ordered head CT. Given that adult patients with mild TBI often present to EDs, which have access to CT scanners, this is a key setting to assess real-world impact of the i-STAT TBI test on CT head utilization.

Key Dates

Start date
Jan 30, 2025
Status verified
Feb 2025
Primary completion
Sep 30, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Notification Arm (Abbott iSTAT TBI test)
    The ED clinicians caring for the enrolled patient, along with the patient, receive the TBI blood test result with just-in-time education on the TBI test to aid in clinical decision making.
  • No Intervention: Non-Notification Arm (Control)
    Clinicians and enrolled patients do not receive the TBI blood test result.

Primary Outcome Measure

Number of Head CT scans canceled [ Time Frame: Within 24 hours of Traumatic Brain Injury ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Jonathan Schimmel, MD
[email protected]
Mitali Pradhan, MS, CCRP
[email protected]
Mount Sinai MorningsideNew YorkNew York10025
Shameeke Taylor, MD, MPH, MSCR
[email protected]
Lauren Gordon, MPH
[email protected]
Mount Sinai WestNew YorkNew York10029
Shameeke Taylor, MD, MPH, MSCR
[email protected]
Lauren Gordon, MPH
[email protected]

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Mount Sinai Hospital· New York, NYMount Sinai Morningside· New York, NYMount Sinai West· New York, NY

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