Evaluating the i-STAT Alinity Blood Test to Improve Traumatic Brain Injury Assessment and CT Scan Decisions in Emergency Departments for Adults with Mild Brain Injury
Led by Shawn Eagle · Updated on 2026-07-06
340
Participants Needed
1
Research Sites
56 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the i-STAT Alinity whole blood test for patients with traumatic brain injury TBI who have a Glasgow Coma Score GCS of 13-15 in emergency departments. The study aims to identify factors influencing the adoption of this FDA-approved test, which measures brain injury biomarkers, and to assess its potential effects on clinical decisions and patient outcomes, such as the need for head CT scans, emergency department length of stay, and return visits.
The study observes patients suspected of mild TBI who present to emergency departments within 24 hours of head injury. The i-STAT Alinity device is used to measure blood biomarkers related to brain injury, while the study assesses how often patients with low biomarker levels still receive CT scans. It also evaluates organizational and physician factors affecting the routine use of the test and develops a site-specific plan to implement the test effectively.
Participants are evaluated during their emergency department visit and followed up remotely after two weeks. Assessments include clinical scales like the Military Acute Concussion Evaluation-2 and symptom inventories, as well as surveys measuring knowledge and decision-making. The study tracks outcomes such as CT scan rates within 5 hours, length of stay in the emergency department, and return visits over two weeks. Implementation success is also monitored through questionnaires over the study period lasting until 2030.
CONDITIONS
Brief Title
Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test
Research Team
S
Shawn Eagle, PhD
K
Kathryn Edelman, MS
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Presenting to an enrolling emergency department with Glasgow Coma Score of 13-15 within 24 hours following head blunt impact
Meets Department of Defense definition of mild traumatic brain injury indicated by alteration of mental status, loss or decreased level of consciousness, or memory loss immediately after 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 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 affecting biomarker levels or requiring 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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation and Observation
Duration - Up to 5 hours
Participants receive evaluation in the emergency department including the i-STAT Alinity blood test and clinical assessments to determine the need for a head CT scan and to gather information on symptoms and injury severity.
1 emergency department visit
Remote Follow-up
Duration - Up to 2 weeks
Participants complete follow-up assessments remotely approximately two weeks after the emergency department visit to evaluate symptoms and any return visits to the emergency department.
1 remote follow-up visit
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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Published Research Related To This Trial
Implementing whole blood TBI point-of-care testing in Level 1 trauma centers: protocol for emergency department implementation for TBI (EDI for TBI) hybrid type II effectiveness-implementation trial.