Actively Recruiting

Age: 18Years +
All Genders
ID07373509

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) in the emergency department

Diagnostic Evaluation

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

Long-term Monitoring

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

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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

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