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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Mount Sinai Hospital
RECRUITING
New York
Mount Sinai Morningside
RECRUITING
New York
Mount Sinai West
RECRUITING
New York
Contact Information
Primary
Mitali Pradhan, MS, CCRP
Mitali.Pradhan@mountsinai.org
201-423-3585
Backup
Jonathan Schimmel, MD
jonathan.schimmel@mountsinai.org
Time Frame
Start Date: 2025-01-30
Estimated Completion Date: 2025-10
Participants
Target number of participants: 450
Treatments
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.
No_intervention: Non-Notification Arm (Control)
Clinicians and enrolled patients do not receive the TBI blood test result.
Related Therapeutic Areas
Sponsors
Leads: Icahn School of Medicine at Mount Sinai
Collaborators: Abbott Point of Care

This content was sourced from clinicaltrials.gov