Clinical trial NCT06766435: Evaluation of the Abbott i-STAT TBI Biomarker Test
Official title: Evaluation of the Abbott i-STAT TBI Biomarker Test for Effect on Decreasing CT Utilization Among Adult Emergency Department Patients With Suspected Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Point of Care Testing
Emergency Care
Clinical Decision Making
Head Injury
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Abbott Point of Care
First posted: 2025-01-09
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multisite randomized controlled clinical trial
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Head CT scans canceled
timeFrame: Within 24 hours of Traumatic Brain Injury
Secondary outcomes:
measure: Subset of Number of Head CT scans completed
timeFrame: Within 24 hours of Traumatic Brain Injury
measure: ED Length of Stay
timeFrame: Day 1 after patient ED care visit has ended
measure: Number of cancellations of head CT scan order in patients on anticoagulants
timeFrame: Day 1 after patient ED care visit has ended
measure: Patient Satisfaction Scale
timeFrame: At 14 days after ED visit
measure: Number of head CT scans completed
timeFrame: At 14 days after ED visit
measure: Stress of Uncertainty Scale (SUS)
timeFrame: Day 1 during patient ED care visit
measure: Malpractice Fear Scale (MFS) Scores
timeFrame: Day 1 during patient ED care visit
measure: Whole blood concentrations of GFAP (glial fibrillary acidic protein)
timeFrame: Day 1 during patient ED care visit
measure: Whole blood concentrations of UCH-L1 (ubiquitin C-terminal hydrolase L1)
timeFrame: Day 1 during patient ED care visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Morningside
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai West
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Shameeke Taylor, MD, MPH, MSCR
role: PRINCIPAL_INVESTIGATOR
References: