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Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test
Sponsor: Shawn Eagle
Summary
The objective of this study is to identify determinants for implementing the i-STAT Alinity whole blood traumatic brain injury (TBI) test for its Food and Drug Administration (FDA)-indicated use and to evaluate other potential outcomes with clinical implications. The main questions it aims to answer are: 1. Determine the number of patients with non-elevated (i.e., below clinical cutoff) whole blood iSTAT Alinity tests who also receive CT scans. 2. What are the obstacles for using the i-STAT Alinity for its FDA-indicated use
Official title: Effectiveness of the Traumatic Brain Injury Whole Blood Test on Improving Assessment and Triage for Patients With GCS 13-15 Presenting to Emergency Departments
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
340
Start Date
2026-01-13
Completion Date
2030-04
Last Updated
2026-02-09
Healthy Volunteers
No
Interventions
i-STAT Alinity TBI test
The i-STAT TBI cartridge is a point-of-care test that measures the level of biomarkers associated with brain injury in whole blood to help assess patients with suspected mTBI within 24 hours after injury.
Locations (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, United States