Clinical Trial

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

Study acronym: EDI
Recruiting
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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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-01-22; most recent amendment 2026-07-01.
Status change: Not Yet Recruiting → Recruiting 2026-02-04
Trial Details
NCT Number NCT07373509
Lead Sponsor Shawn Eagle
Collaborators: United States Department of Defense
Conditions TBI (Traumatic Brain Injury), Implementation Research
Enrollment 340 participants
Start Date 2026-01-13
Primary Completion 2029-03 (estimated)
Study Completion 2030-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-06