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Recruiting NCT06932588

Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma

Trial Parameters

Condition Brain Injuries
Sponsor Emory University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 350
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-05-31
Completion 2026-06
Interventions
Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT

Brief Summary

This study aims to determine whether a blood test can help doctors decide when to use a head CT scan for patients with a mild head injury. Researchers are investigating whether the results from this blood test can aid in making better decisions about patient care and potentially reduce the need for imaging. In this study, researchers will collect blood samples to assess whether this specific blood test can help doctors decide when head imaging is necessary following a head injury. The goal is to determine whether the use of this test can reduce the number of head imaging procedures performed in the emergency department (ED).

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 years and older * Mild TBI, defined as Glasgow Coma Scale (GCS) score 13-15, presenting within 24 hours of injury * No prior head imaging for the same incident * Presenting within 24 hours of onset of injury Exclusion Criteria: * Patients with penetrating head injury * History of known brain abnormality including tumor, cerebrovascular malformation, recent brain surgery (within 6 months), prior head injury (within 6 months) * Need for emergent surgical intervention for brain or alternate body organ injury * Need for emergent bedside procedures for hemodynamic or orthopedic stabilization * Patients deemed at higher risk for decline by the provider prohibit the 15-minute delay in obtaining imaging needed for biomarker testing.

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