i-STAT Alinity whole-blood test for adults with head injury in the emergency department

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational implementation project uses the i-PARIHS framework to study use of the i-STAT Alinity whole-blood TBI test in emergency departments. About 140 adult patients with GCS 13–15 will be enrolled (roughly 47 per site) to compare test results with CT utilization and clinical outcomes. Key outcomes include the proportion of patients with non-elevated test results who still receive CT scans, differences in ED length of stay when the test is used, and the test's ability to predict return ED visits for the same injury. The study also measures implementation determinants such as acceptability, adoption, appropriateness, and feasibility at organizational and provider levels.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 or older
2. Presenting to an enrolling ED with ED Arrival GCS of 13-15 following reported head blunt impact within 24 hours of injury
3. 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:

1. Any alteration of mental status (e.g., feeling dazed, disoriented, or confused)
2. 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)
3. Any loss of memory for events immediately before or after the injury (post-traumatic amnesia up to 1-day post-injury)

Exclusion Criteria:

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

Where it's running

• University of Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Shawn Eagle, PhD — University of Pittsburgh
• Study coordinator: Shawn Eagle, PhD
• Email: eaglesr2@upmc.edu
• Phone: 412-624-2041

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.