RecruitingNot ApplicableNCT06932588

Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma

Sponsor

Emory University

Enrollment

350 participants

Start Date

May 31, 2025

Study Type

INTERVENTIONAL

Conditions

Brain Injuries Head Injury

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria5

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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Interventions

DIAGNOSTIC_TESTBiomarker 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.