Actively Recruiting
A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
Led by University of California, Davis · Updated on 2025-12-11
4346
Participants Needed
6
Research Sites
210 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
P
Pediatric Emergency Care Applied Research Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children younger than 18 years of age (0 to 17.9999 years) with blunt abdominal trauma presenting to participating emergency departments within 24 hours of injury
- Blunt torso trauma from significant events such as motor vehicle collision over 60 mph, ejection, or rollover
- Automobile versus pedestrian/bicycle collisions where the vehicle speed was over 25 mph
- Falls from a height greater than 20 feet
- Crush injury to the torso
- Physical assault involving the abdomen
- Decreased level of consciousness (Glasgow Coma Scale score 9-14 or below age-appropriate behavior) with blunt torso trauma
- Blunt trauma with extremity paralysis or multiple long bone fractures
- History and physical exam indicating blunt torso trauma regardless of injury severity
You will not qualify if you...
- Age-adjusted low blood pressure indicating hemodynamic instability at or before emergency department arrival
- Penetrating trauma such as stab or gunshot wounds
- Injury occurred more than 24 hours before emergency department presentation
- Transfer from another facility with prior abdominal CT scan, diagnostic peritoneal lavage, or laparotomy
- Transfer from another facility with FAST exam already performed
- Known diseases causing intraperitoneal fluid like liver failure or ventriculoperitoneal shunts
- Initial Glasgow Coma Scale score of 8 or less
- Known pregnancy
- Known prisoner status
- Known intra-abdominal injury diagnosed within 30 days before this emergency department visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
2
University of Colorado, Anschutz Medical Center and Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Emory University Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
5
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
6
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
J
James F Holmes, MD, MPH
CONTACT
N
Nathan Kuppermann, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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