Evaluation of the Abbott i-STAT TBI Biomarker Test

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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: i-STAT TBI Test

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mitali Pradhan, MS, CCRP; Phone Number: 201-423-3585; Email: Mitali.Pradhan@mountsinai.org
• Study Contact Backup: Name: Jonathan Schimmel, MD; Email: jonathan.schimmel@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Jonathan Schimmel, MD; Email: jonathan.schimmel@mountsinai.org
      • Contact: Mitali Pradhan, MS, CCRP; Email: mitali.pradhan@mountsinai.org
    • New York, New York, United States, 10025
      • Recruiting
      • Mount Sinai Morningside
      • Contact: Lauren Gordon, MPH; Email: lauren.gordon@mountsinai.org
      • Contact: Shameeke Taylor, MD, MPH, MSCR; Email: shameeke.taylor@mountsinai.org
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai West
      • Contact: Lauren Gordon, MPH; Email: lauren.gordon@mountsinai.org
      • Contact: Shameeke Taylor, MD, MPH, MSCR; Email: shameeke.taylor@mountsinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: i-STAT TBI Test; The Abbott i-STAT TBI test result is shared with the enrolled patient and treating clinicians.; Other Names: Abbott iSTAT Alinity
No Intervention: Non-Notification Arm (Control); Clinicians and enrolled patients do not receive the TBI blood test result.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Head CT scans canceled	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)	Within 24 hours of Traumatic Brain Injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subset of Number of Head CT scans completed	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)	Within 24 hours of Traumatic Brain Injury
ED Length of Stay	Length of stay for the Emergency Department patient encounter	Day 1 after patient ED care visit has ended
Number of cancellations of head CT scan order in patients on anticoagulants	Number of cancellations in head CTs in patients on anticoagulation	Day 1 after patient ED care visit has ended
Number of head CT scans completed	Number of head CT scans completed for patients within 14 days after index ED visit	At 14 days after ED visit
Stress of Uncertainty Scale (SUS)	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.	Day 1 during patient ED care visit
Malpractice Fear Scale (MFS) Scores	Malpractice Fear Scale (MFS) scores. MFS scores range from 6 to 36 with a higher score indicating greater fear of malpractice.	Day 1 during patient ED care visit
Whole blood concentrations of GFAP (glial fibrillary acidic protein)	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.	Day 1 during patient ED care visit
Whole blood concentrations of UCH-L1 (ubiquitin C-terminal hydrolase L1)	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.	Day 1 during patient ED care visit
Patient Satisfaction Scale	Assessment of patient satisfaction with care during ED visit. Full scale from 1 (worst care possible) to 10 (best care possible)	At 14 days after ED visit

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Abbott Point of Care
• Investigators: Principal Investigator: Shameeke Taylor, MD, MPH, MSCR, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: January 4, 2025
• First Submitted That Met QC Criteria: January 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Point of Care Testing; Emergency Care; Clinical Decision Making; Head Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Brain Injuries
• Other Study ID Numbers: STUDY-24-01057; CRS-2024-001-257 (Other Grant/Funding Number: Abbott Point of Care)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes