Evaluation of the Abbott i-STAT TBI Biomarker Test

Mount Sinai Health System

Status: Enrolling

Conditions: Traumatic Brain Injury

Treatments: Device: i-STAT TBI Test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06766435

CRS-2024-001-257 (Other Grant/Funding Number)

STUDY-24-01057

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Notification Arm (Abbott iSTAT TBI test)

Experimental group

Description:

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.

Treatment:

Device: i-STAT TBI Test

Non-Notification Arm (Control)

No Intervention group

Description:

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