i-STAT Alinity whole-blood test for adults with head injury in the emergency department
Effectiveness of the Traumatic Brain Injury Whole Blood Test on Improving Assessment and Triage for Patients With GCS 13-15 Presenting to Emergency Departments
This project will try the i-STAT Alinity whole-blood test in adults with recent mild head injuries (GCS 13–15) to see if it helps decide who needs a head CT.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07373509 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older who present to a participating ED within 24 hours of blunt head trauma, have a Glasgow Coma Scale of 13–15, and meet the DoD definition of mild TBI are the intended participants.
Not a fit: Patients with more severe injuries (GCS <13), those for whom the treating clinician already decides a CT is unnecessary, or cases where the i-STAT Alinity result cannot be obtained in a timely manner are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, using this blood test could reduce unnecessary head CTs, shorten ED stays, and help clinicians make faster, safer decisions after mild head injury.
How similar studies have performed: Preliminary data and prior biomarker research suggest similar test performance (about 21% of non-elevated tests paired with CT scans), but routine ED implementation of this whole-blood platform is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.