Status:

RECRUITING

Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma

Lead Sponsor:

Emory University

Collaborating Sponsors:

Abbott

Conditions:

Brain Injuries

Head Injury

Eligibility:

All Genders

18+ years

Phase:

NA

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 b...

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 nece...

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.

Key Trial Info

Start Date :

May 31 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

350 Patients enrolled

Trial Details

Trial ID

NCT06932588

Start Date

May 31 2025

End Date

June 1 2026

Last Update

December 15 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Grady Health System

Atlanta, Georgia, United States, 30303