NCT07373509

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

Effectiveness of the Traumatic Brain Injury Whole Blood Test on Improving Assessment and Triage for Patients With GCS 13-15 Presenting to Emergency Departments

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 340 (estimated)
• Sponsor: Shawn Eagle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Objective: The objective of this study is to utilize the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to identify determinants for implementing the 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. Specific Aims \& working hypotheses: Aim 1) Evaluate the effectiveness of the whole blood iSTAT Alinity test in determining the need for a head computed tomography (CT) scan in approximately 140 patients with a Glasgow Coma Score (GCS) 13-15 in the emergency department (ED) (approximately 47 per site) while assessing two novel outcomes with significant clinical implications (i.e., reduction in ED length of stay and predictive utility for ED revisits for the same injury). • The working hypotheses are that the rate of patients with non-elevated (i.e., below clinical cutoff) whole blood iSTAT Alinity tests who also receive CT scans will mirror the preliminary study results (21 percent), a reduction in ED length of stay will be observed (in comparison to also receiving a CT scan) of greater than 3 hours, and predictive utility for return ED visits from the same injury will be high (area under the curve greater than 0.80). Aim 2) Evaluate determinants for routine use of the whole blood iSTAT Alinity test by assessing acceptability, adoption, appropriateness and feasibility of the test at the organizational- and physician-level for each site and determine how these factors interplay with patient perspectives and knowledge to influence implementation of the test. • The working hypotheses are that organization-, physician-, and patient-level determinants will be identified and gaps in patient knowledge will be observed. A diverse Community Advisory Board (CAB) will be assembled to provide important context of how these varying perspectives impact the whole blood iSTAT Alinity test utilization. We will also obtain community knowledge and perspective on this test via the CAB. Aim 3) Develop a site-specific implementation blueprint for use of the whole blood iSTAT Alinity test in determining the need for a head CT scan and pilot test the blueprint in approximately 140 patients with GCS 13-15 in the ED (approximately 47 per site). • The working hypothesis is that an implementation blueprint that targets identified determinants in Aim 2 will lead to a reduction in the rate of patients with negative whole blood iSTAT tests who also receive CT scan to 5 percent or less.

Conditions

• TBI (Traumatic Brain Injury)
• Implementation Research

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-13
• Primary completion: 2029-03-01
• Completion: 2030-04-01
• First posted: 2026-01-28
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study