Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06932588
Status
Recruiting
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Conditions

  • Brain Injuries
  • Head Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
May 31, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Published Biomarker Group
    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.
  • Active Comparator: Blinded Biomarker Group
    Biomarker results are not disclosed during the decision-making process for cranial imaging.

Primary Outcome Measure

Proportion of participants having a CT head scan from biomarker positive [ Time Frame: During hospital admission (average 15 days). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Grady Health SystemAtlantaGeorgia30303
Ali Tfaily
[email protected]
404-616-1000
Ali Alawieh, MD PhD (SUB_INVESTIGATOR)

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By research site
Grady Health System· Atlanta, GA

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