Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma

NCT06932588 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY000087112025P010295
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Brain Injuries; Head Injury

Keywords

Biomarkers; Brain imaging; Brain trauma; Head CT scan; Mild traumatic brain injury (mTBI)

Outcome Measures

Primary Outcomes (1)

• Proportion of participants having a CT head scan from biomarker positive

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

  During hospital admission (average 15 days).

Secondary Outcomes (4)

• Length of hospital stay

  Hospital admission (average 15) days.

• Number of participants with intracranial findings predicted by biomarker findings

  Hospital admission (average 15) days.

• Number of readmissions for TBI-related symptoms

  up to 6 months after hospital discharge

• Glasgow Outcome Scale-Extended (GOS-E)

  6 months after hospital discharge

Study Arms (2)

Published Biomarker Group

EXPERIMENTAL

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.

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

Blinded Biomarker Group

ACTIVE COMPARATOR

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

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

Interventions

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.

Also known as: i-STAT TBI

Blinded Biomarker Group; Published Biomarker Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Abbott: collaborator

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

Related Publications (1)

• Tfaily A, Chacon A, Ma T, Ratcliff J, Smith R, Saad H, Reisner A, Gimbel D, Wang K, Kobeissy F, Grossberg JA, Alawieh AM. Biomarker role in assessing imaging needs for mild cranial trauma (BRAIN-CT): study protocol for a single-center, randomized controlled trial. Front Neurol. 2026 Jan 9;16:1692163. doi: 10.3389/fneur.2025.1692163. eCollection 2025.

  PMID: 41586091 DERIVED

MeSH Terms

Conditions

Brain Injuries; Craniocerebral Trauma; Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Jonathan Grossberg, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Tfaily, MS

CONTACT

404-616-1000; ali.tfaily@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: May 31, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be shared starting 12 months and ending 3 years after the article's publication.
• Access Criteria: Investigators with approved data use by an Institutional Review Board may submit proposals up to 3 years after the article's publication.

Locations

US (1)