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Studies

Interventional Active not recruiting

NCT06932588 on ClinicalTrials.gov

Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma

  • Sponsor: Emory University
  • Collaborators: Abbott
  • Enrollment: 351 (Actual)
  • Study start: 2025-05-31 (Actual)
  • Primary completion: 2026-07-09 (Actual)
  • Study completion: 2027-07-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Double (Participant, Care Provider)
  • PrimaryPurpose: Diagnostic

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

Intervention / Treatment

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

Primary Outcome Measures

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

Countries

United States

Locations and Investigators

  • Grady Health System, Atlanta, United States

Study Officials