Actively Recruiting
Effectiveness of the Traumatic Brain Injury Whole Blood Test on Improving Assessment and Triage for Patients With GCS 13-15 Presenting to Emergency Departments
Led by Shawn Eagle · Updated on 2026-02-09
340
Participants Needed
1
Research Sites
56 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
This research aims to identify factors that affect the use of the i-STAT Alinity whole blood test for traumatic brain injury (TBI) in emergency departments, focusing on patients with a Glasgow Coma Score (GCS) of 13-15. The study evaluates how well this test helps decide if a head CT scan is needed, assesses its impact on emergency department length of stay, and predicts return visits for the same injury. It also explores organizational, physician, and patient views on using the test and develops tailored plans to improve its implementation. The study involves assessing approximately 140 patients with suspected mild TBI across multiple sites. The i-STAT Alinity TBI test measures brain injury biomarkers from whole blood within 24 hours after injury. Researchers will observe current emergency department practices, including use of CT scans, and pilot an implementation plan designed to reduce unnecessary CT scans in patients with negative i-STAT results. The study gathers data from healthcare providers, patients, and community advisory boards to understand challenges and acceptance of the test. Participants will be evaluated during their emergency department visit, including tests like the i-STAT Alinity TBI test, Glasgow Coma Score assessment, and concussion-related questionnaires. Researchers will track rates of CT scans completed within 5 hours, emergency department length of stay, and patient return visits within two weeks. Surveys and implementation tools will be used at enrollment and study conclusion to measure adoption and feasibility. The total study duration spans from enrollment through a 39-month observation period for implementation outcomes.
CONDITIONS
Brief 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...
- Aged 18 or older
- Presenting to an enrolling emergency department with Glasgow Coma Score of 13-15 after a reported blunt head injury within 24 hours
- Meets Department of Defense definition of mild traumatic brain injury, including altered mental status, loss or decreased consciousness up to 24 hours, or memory loss up to 1 day post-injury
You will not qualify if you...
- Emergency department provider does not think a head CT scan is needed
- Unable to obtain i-STAT Alinity test results within 24 hours of injury
- Treating emergency department attending physician unwilling to participate
- Pre-existing neurologic condition
- Contraindication or inability to complete blood draw
- Significant polytrauma possibly affecting test results or requiring full body scan
- History of penetrating traumatic brain injury
- History of neurosurgical intervention for previous TBI
- Penetrating TBI for current injury
- Any history of brain surgery
- Any history of brain tumor
- Patients currently on psychiatric hold
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) in the emergency department
Duration - Up to 5 hours
Participants undergo the i-STAT Alinity Traumatic Brain Injury whole blood test to assess the need for a head CT scan and other clinical assessments in the emergency department.
1 visit (in-person) in the emergency department
Duration - Up to two weeks
Participants are followed remotely to assess outcomes such as return visits to the emergency department and symptom inventories related to traumatic brain injury.
1 remote follow-up visit
Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
S
Shawn Eagle, PhD
K
Kathryn Edelman, MS
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here