Evaluation of the Abbott i-STAT TBI Biomarker Test

NCT06766435 | Recruiting FDA Device

• 2 other identifiers: STUDY-24-01057CRS-2024-001-257
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 3

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.

Conditions

Traumatic Brain Injury

Keywords

Point of Care Testing; Emergency Care; Clinical Decision Making; Head Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Subset of Number of Head CT scans completed

  Within 24 hours of Traumatic Brain Injury

• ED Length of Stay

  Day 1 after patient ED care visit has ended

• Number of cancellations of head CT scan order in patients on anticoagulants

  Day 1 after patient ED care visit has ended

• Patient Satisfaction Scale

  At 14 days after ED visit

• Number of head CT scans completed

  At 14 days after ED visit

Study Arms (2)

Notification Arm (Abbott iSTAT TBI test)

EXPERIMENTAL

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

Non-Notification Arm (Control)

NO INTERVENTION

Clinicians and enrolled patients do not receive the TBI blood test result.

Interventions

i-STAT TBI Test DEVICE

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

Also known as: Abbott iSTAT Alinity

Notification Arm (Abbott iSTAT TBI test)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Abbott Point of Care: collaborator

Study Sites (3)

Mount Sinai Morningside

New York, New York, 10025, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Mount Sinai West

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Shameeke Taylor, MD, MPH, MSCR

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitali Pradhan, MS, CCRP

CONTACT

201-423-3585; Mitali.Pradhan@mountsinai.org

Jonathan Schimmel, MD

CONTACT

jonathan.schimmel@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patient is randomized to the intervention or control arm after consent is obtained. There is no masking for the treatment arm assignment. In the non-notification arm (control arm) participants and care providers will not learn the results of the i-STAT TBI test.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Model Details: Multisite randomized controlled clinical trial

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 9, 2025
• Study Start: January 30, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)