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RECRUITING
NCT06932588
NA

Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma

Sponsor: Emory University

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2025-05-31

Completion Date

2026-06

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT

The i-STAT TBI cartridge is a point-of-care, whole-blood, biomarker-based assay that measures the level of biomarkers associated with brain injury in the bloodstream 24 hours after injury. Blood samples (5-10cc of whole blood) will be collected upon admission during a routine blood drawing in the ED. These samples will be tested using the iSTAT system for mild TBI biomarkers. In a subset of admitted patients, serial blood draws and iSTAT testing will be performed at 4, 8, 16, and 24 hours, depending on the patient's length of stay.

Locations (1)

Grady Health System

Atlanta, Georgia, United States