Evaluation of the Abbott i-STAT TBI Biomarker Test

NCT ID: NCT06766435

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2025-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

i-STAT TBI Test

Intervention Type: DEVICE

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

Non-Notification Arm (Control)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

i-STAT TBI Test

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

Intervention Type: DEVICE

Other Intervention Names

Abbott iSTAT Alinity

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Point of Care

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Shameeke Taylor

Assistant Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shameeke Taylor, MD, MPH, MSCR

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Morningside

New York, New York, United States

Site Status: RECRUITING

Mount Sinai Hospital

New York, New York, United States

Site Status: RECRUITING

Mount Sinai West

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mitali Pradhan, MS, CCRP

Role: CONTACT

Mitali.Pradhan@mountsinai.org

201-423-3585

Jonathan Schimmel, MD

Role: CONTACT

jonathan.schimmel@mountsinai.org

Facility Contacts

Shameeke Taylor, MD, MPH, MSCR

Role: primary

shameeke.taylor@mountsinai.org

Lauren Gordon, MPH

Role: backup

lauren.gordon@mountsinai.org

Jonathan Schimmel, MD

Role: primary

jonathan.schimmel@mountsinai.org

Mitali Pradhan, MS, CCRP

Role: backup

mitali.pradhan@mountsinai.org

Shameeke Taylor, MD, MPH, MSCR

Role: primary

shameeke.taylor@mountsinai.org

Lauren Gordon, MPH

Role: backup

lauren.gordon@mountsinai.org

Other Identifiers

CRS-2024-001-257

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY-24-01057

Identifier Type: -

Identifier Source: org_study_id