Evaluation of the Abbott i-STAT TBI Biomarker Test

Recruiting now · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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 facts

Study ID: NCT06766435
Run by: Icahn School of Medicine at Mount Sinai
People needed: 450
Starts: 2025-01-30
Expected to finish: 2025-10-01
Last updated by the study team: 2025-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18 years
Head injury within 24 hours of research blood collection
CT head ordered as part of routine care, not yet completed.
Glasgow Coma Scale (GCS) 13 - 15

You may not qualify if…

Unknown whether head injury occurred, and signs of head injury are absent
Previously enrolled in this study in the past 30 days
Prisoner or in police custody or known pregnancy
Suspected current ischemic or hemorrhagic stroke
Suspected open or depressed skull fracture, or signs of skull base fracture
History of multiple sclerosis
Venipuncture not feasible

Where it is running

Mount Sinai Morningside — New York, New York, United States (enrolling)
Mount Sinai Hospital — New York, New York, United States (enrolling)
Mount Sinai West — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.