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Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma

NCT06932588 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-12-15

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

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.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Jonathan Grossberg, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06932588 on ClinicalTrials.gov