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

This study is looking at whether a blood test called the Alinity Whole-blood TBI biomarker i-STAT can help doctors decide if you need a head CT scan after a mild head injury. Researchers will collect a small blood sample (5-10cc) when you arrive at the hospital. The goal is to see if using this blood test can help reduce the number of head CT scans performed and improve patient care. You could be eligible if you are an adult (18 or older) with a mild head injury (Glasgow Coma Scale score 13-15) and arrive at the hospital within 24 hours of your injury. The main thing they are measuring is how many people who test positive with the biomarker still get a head CT scan.

Study design
This is an interventional study planning to enroll 350 participants. Healthcare providers will be randomly assigned to either know or not know the biomarker test results when deciding on a CT scan.
What's involved
You would have a blood sample (5-10cc) collected upon admission during a routine blood drawing.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured during hospital admission (average 15 days).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06932588

Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma

Active, Not Recruiting
NAAges 18+InterventionalDiagnostic
Emory University
~351 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants having a CT head scan from biomarker positive
Measured over During hospital admission (average 15 days).

Conditions

Brain Injuries
Head Injury

Explore related trials

Brain InjuryConcussion

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Jonathan Grossberg, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proportion of participants having a CT head scan from biomarker positiveDuring hospital admission (average 15 days).

    The impact of biomarker results will be measured by the decision to obtain CT head imaging for patients presenting with mild TBI.