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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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