Actively Recruiting
Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test
Led by Shawn Eagle · Updated on 2026-02-09
340
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
Sponsors
S
Shawn Eagle
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Presenting to an enrolling emergency department with a Glasgow Coma Score of 13-15 after a reported blunt head impact within 24 hours of injury
- Meets Department of Defense definition of mild traumatic brain injury, including at least one of the following immediately after the event: alteration of mental status (e.g., feeling dazed, disoriented, or confused), loss or decreased level of consciousness (up to 30 minutes loss or 24 hours alteration), or loss of memory for events immediately before or after injury (up to 1 day post-injury)
You will not qualify if you...
- Treating emergency department provider does not think a head CT scan is needed
- Unable to obtain i-STAT Alinity TBI test results 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 might affect peripheral GFAP levels or require a full body scan
- History of penetrating traumatic brain injury
- History of neurosurgical intervention for previous traumatic brain injury
- Penetrating traumatic brain injury for current injury
- Any history of brain surgery
- Any history of brain tumor
- Patients on psychiatric hold
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
S
Shawn Eagle, PhD
CONTACT
K
Kathryn Edelman, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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