Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma (BRAIN-CT)

Emory University

Status: Enrolling

Conditions: Brain Injuries; Head Injury

Treatments: Diagnostic Test: Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06932588

2025P010295 (Other Identifier)

STUDY00008711

Details and patient eligibility

About

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).

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups

Published Biomarker Group

Experimental group

Description:

Biomarker results are provided to the ED provider immediately and before the decision to order a head CT is made. A print-out of the results will be handed to the provider or uploaded to the epic platform.

Treatment:

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

Blinded Biomarker Group

Active Comparator group

Description:

Biomarker results are not disclosed during the decision-making process for cranial imaging.

Treatment:

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