Evaluation of the Abbott i-STAT TBI Biomarker Test

Not Applicable

Recruiting

• Conditions: Traumatic Brain Injury

• Registration Number: NCT06766435
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-04
• Study First Submitted QC: 2025-01-04
• Study First Posted: 2025-01-09
• Study Start: 2025-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Head CT scans canceled	Within 24 hours of Traumatic Brain Injury	Number of head CTs canceled in patients not on anticoagulants as measurement of percentage of reduction in the number of canceled head CTs out of total head CTs ordered (total number and percentage)

Secondary Outcome Measures

Name	Time	Method
Subset of Number of Head CT scans completed	Within 24 hours of Traumatic Brain Injury	If the i-STAT TBI test results had been strictly adhered to by clinicians, subset of negative i-STAT TBI test results, Potential reduction in the number of completed head CTs (canceled) out of total head CTs ordered (total number and percentage)
ED Length of Stay	Day 1 after patient ED care visit has ended	Length of stay for the Emergency Department patient encounter
Number of cancellations of head CT scan order in patients on anticoagulants	Day 1 after patient ED care visit has ended	Number of cancellations in head CTs in patients on anticoagulation
Patient Satisfaction Scale	At 14 days after ED visit	Assessment of patient satisfaction with care during ED visit. Full scale from 1 (worst care possible) to 10 (best care possible)
Number of head CT scans completed	At 14 days after ED visit	Number of head CT scans completed for patients within 14 days after index ED visit
Stress of Uncertainty Scale (SUS)	Day 1 during patient ED care visit	Clinicians vary in their use of diagnostic testing and treatments, and stress of uncertainty may be one explanation for this variation. The stress of uncertainty scale measures clinician tolerance of uncertainty during patient care. SUS scores range from 15-90 with a higher score indicating greater fear of uncertainty.
Malpractice Fear Scale (MFS) Scores	Day 1 during patient ED care visit	Malpractice Fear Scale (MFS) scores. MFS scores range from 6 to 36 with a higher score indicating greater fear of malpractice.
Whole blood concentrations of GFAP (glial fibrillary acidic protein)	Day 1 during patient ED care visit	Whole blood concentrations for GFAP on the iSTAT device. Biomarker for use with mild TBI within 24 hours of injury to aid in determining the need for head CT imaging.
Whole blood concentrations of UCH-L1 (ubiquitin C-terminal hydrolase L1)	Day 1 during patient ED care visit	Whole blood concentrations for UCH-L1 on the iSTAT device. Biomarker for use with mild TBI within 24 hours of injury to aid in determining the need for head CT imaging.

Trial Locations

Locations (3)

Mount Sinai Morningside; 🇺🇸 New York, New York, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Mount Sinai West; 🇺🇸 New York, New York, United States