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RECRUITING
NCT07373509

Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test

Sponsor: Shawn Eagle

View on ClinicalTrials.gov

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

DEVICE

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