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

Recruiting now

Conditions studied: TBI (Traumatic Brain Injury), Implementation Research

In brief

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

Key facts

Study ID

NCT07373509

Run by

Shawn Eagle

People needed

340

Starts

2026-01-13

Expected to finish

2030-04-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 or older
• Presenting to an enrolling ED with ED Arrival GCS of 13-15 following reported head blunt impact within 24 hours of injury
• Meets Department of Defense (DoD) definition of mTBI:
• A traumatically induced physiological disruption of brain function as a result of an external force that is indicated by new onset or worsening of at least one of the following clinical signs immediately following the event:
• Any alteration of mental status (e.g., feeling dazed, disoriented, or confused)
• Any period of loss of or a decreased level of consciousness, observed or self-report (loss of consciousness 30 minutes or less, an alteration of consciousness up to 24 hours)
• Any loss of memory for events immediately before or after the injury (post-traumatic amnesia up to 1-day post-injury)

You may not qualify if…

• Treating emergency department provider does not think a head CT scan is needed
• Inability to obtain results for iSTAT Alinity TBI test within 24 hours of injury
• Treating emergency department attending physician is not willing to participate
• Pre-existing neurologic condition
• Contraindication or inability to complete blood draw
• Significant polytrauma that, in the opinion of the principal investigators, could impact peripheral GFAP levels or require a full body scan
• History of penetrating TBI
• History of neurosurgical intervention for previous TBI
• Penetrating TBI for current injury
• Any history of brain surgery
• Any history of brain tumor
• Patients on psychiatric hold

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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