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RECRUITING
NCT05910567
NA

A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma

Sponsor: University of California, Davis

View on ClinicalTrials.gov

Summary

Bleeding from intra-abdominal injuries is a leading cause of traumatic deaths in children. Abdominal CT is the reference standard test for diagnosing intra-abdominal injuries. Compelling reasons exist, however, to both aggressively evaluate injured children for intra-abdominal injuries with CT and to limit abdominal CT evaluation to solely those at non-negligible risk. The focused assessment sonography for trauma (FAST) examination can help focus patient evaluation in just this manner by potentially safely decreasing abdominal CT use in low risk children. This research study is a multicenter, randomized, controlled trial to determine whether use of the FAST examination, a bedside abdominal ultrasound, impacts care in 3,194 hemodynamically stable children with blunt abdominal trauma. The overall objectives of this proposal are 1) to determine the efficacy of using the FAST examination during the initial evaluation of children with blunt abdominal trauma, and 2) to identify factors associated with abdominal CT use in children considered very low risk for IAI after a negative FAST examination. The long-term objective of the research is to determine appropriate evaluation strategies to optimize the care of injured children, leading to improved quality of care and a reduction in morbidity and mortality.

Official title: A Randomized Controlled Trial of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma

Key Details

Gender

All

Age Range

Any - 17 Years

Study Type

INTERVENTIONAL

Enrollment

4346

Start Date

2023-04-17

Completion Date

2027-04-30

Last Updated

2025-12-11

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Focused Assessment with Sonography for Trauma (FAST) Examination

A bedside Focused Assessment with Sonography for Trauma (FAST) Examination will be conducted on those participants who are randomized to the FAST arm.

OTHER

No Intervention: Standard of Care - Without the FAST Examination

Participants randomized to usual care will be evaluated per the standard operating procedures of the institution/site for the condition under study without the FAST exam.

Locations (6)

University of California, Davis Medical Center

Sacramento, California, United States

University of Colorado, Anschutz Medical Center and Children's Hospital Colorado

Aurora, Colorado, United States

Emory University Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States