NCT06932588

Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma (BRAIN-CT) study aims to determine whether immediate access to blood biomarker data can help doctors decide when a CT scan is necessary for patients with mild traumatic brain injury (mTBI). The study will also explore how biomarker data influences clinical outcomes, such as hospital stay duration, costs, and recovery. Additionally, it will identify specific patient groups where biomarker results may alter imaging decisions, assess the ability of biomarkers to predict worsening symptoms and develop predictive models to improve the accuracy of these tests compared to CT scans. The study will enroll adults presenting with suspected mild traumatic brain injury (mTBI) in the emergency department at Grady Memorial Hospital. Minors, pregnant individuals, wards of the state, prisoners, and those with cognitive impairments will not be enrolled. Participants will undergo blood-based biomarker testing upon ED presentation. Healthcare providers will be randomly assigned to either be blinded to the biomarker results or receive the results to guide their decision on ordering head CT imaging.

Conditions

• Brain Injuries
• Head Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-31
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-04-17
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study