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NCT Number: NCT06932588

Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grady Health System

Atlanta, Georgia, 30303, United States

Location status: Recruiting

Location contact

Ali Alawieh, MD PhD

SUB_INVESTIGATOR

Ali Tfaily

CONTACT

[email protected]

404-616-1000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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.

Other names: i-STAT TBI

Primary outcomes

  1. Proportion of participants having a CT head scan from biomarker positive

    Time frame: During 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.

Secondary outcomes

  1. Length of hospital stay

    Time frame: Hospital admission (average 15) days.

    Length of hospital stay until discharge

  2. Number of participants with intracranial findings predicted by biomarker findings

    Time frame: Hospital admission (average 15) days.

    In participants undergoing CT head imaging, the proportion of participants with intracranial findings between biomarker-positive and biomarker-negative groups will be compared.

  3. Number of readmissions for TBI-related symptoms

    Time frame: up to 6 months after hospital discharge

    Data will be taken from electronic medical records (EMR) and participant's interviews.

  4. Glasgow Outcome Scale-Extended (GOS-E)

    Time frame: 6 months after hospital discharge

    Functional outcome measured by the GOS-E. The Glasgow Outcome Scale-Extended (GOS-E) is one of the most widely used outcome instruments to assess global disability and recovery after traumatic brain injury. The patient's overall rating is based on the lowest outcome category indicated on the scale. The overall rating is the lowest outcome category indicated by the person's answers (after discounting limitations or problems before injury). Deaths are taken from records, and on the GOS-E rating schema, a vegetative state (VS) or a score of 2 is the lowest category, and Upper Good Recovery (Upper GR) or a score of 8 is the highest. If the person has no limitations or impaired symptoms, their GOS-E rating is Upper GR (8).

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Tfaily, MS

CONTACT

[email protected]

404-616-1000

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Abbott

Registry information

Acronym: BRAIN-CT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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