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

NCT07373509 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 340

Last updated 2026-02-09

No results posted yet for this study

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

Conditions

  • TBI (Traumatic Brain Injury)
  • Implementation Research

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Shawn Eagle

    lead OTHER

Principal Investigators

  • Shawn Eagle, PhD · University of Pittsburgh

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2029-03-31
Completion
2030-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07373509 on ClinicalTrials.gov