What is this study trying to find out about blunt abdominal trauma in children?

This study is evaluating whether using a bedside ultrasound called the FAST examination can reduce the need for abdominal CT scans in children with blunt abdominal trauma. Researchers want to see if this approach safely decreases CT use and helps identify injuries while improving care. The study is led by the University of California, Davis.

Who may be eligible for this blunt abdominal trauma clinical trial?

Children under 18 years who have experienced blunt abdominal trauma within 24 hours, without penetrating injuries or low blood pressure, may be eligible. The study includes both boys and girls and excludes those with certain medical conditions like liver failure. Please review eligibility criteria for more details.

Is there any cost to participate in this blunt abdominal trauma clinical trial?

Study-related care, including the ultrasound and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 0 - 17Years

All Genders

ID05910567

Study of Abdominal Ultrasound FAST to Evaluate Blunt Torso Trauma in Children Under 18

Led by University of California, Davis · Updated on 2025-12-11

4346

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Trauma is a leading cause of death in children in the US, with abdominal trauma accounting for 30% of pediatric traumatic deaths, second only to brain injury. This research evaluates the use of the Focused Assessment with Sonography for Trauma FAST examination, a bedside abdominal ultrasound, to determine if it can safely reduce abdominal CT scans in hemodynamically stable children with blunt abdominal trauma. The study aims to improve care quality and reduce morbidity and mortality by identifying appropriate evaluation strategies for injured children. The trial is a multicenter, randomized, controlled study involving 3,194 children under 18 years presenting within 24 hours of blunt abdominal trauma. Participants are assigned to either the FAST examination arm, where a bedside ultrasound is performed to detect blood in the abdomen, or to the standard care arm without FAST. The FAST exam is quick, radiation-free, and performed by emergency or trauma physicians. The study compares CT scan rates and tracks delayed or missed diagnoses of intra-abdominal injuries over up to 30 days. Throughout the emergency department stay and initial hospitalization up to 24 hours, participants undergo assessments including FAST or standard evaluation, CT scan monitoring, and tracking of injuries for up to 30 days if hospitalized. Outcomes measured include CT scan frequency, missed injuries, emergency department length of stay, hospitalization rates, physician suspicion of injury, and surgery rates. The study also examines factors influencing CT use in low-risk patients after a negative FAST exam, aiming to optimize diagnostic care in pediatric trauma.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Children younger than 18 years of age (0 to 17.9999 years) with blunt abdominal trauma presenting within 24 hours of injury
Blunt torso trauma from significant injury mechanisms such as high-speed motor vehicle collisions, automobile versus pedestrian/bicycle injuries at speeds over 25 mph, falls greater than 20 feet, crush injuries to the torso, or physical assaults involving the abdomen
Decreased level of consciousness with Glasgow Coma Scale score 9-14 or age-appropriate behavior changes related to blunt torso trauma
Blunt trauma with signs such as extremity paralysis or multiple long bone fractures
History and physical exam suggestive of blunt torso trauma regardless of injury mechanism severity

You will not qualify if you...

Age-adjusted low blood pressure indicating hemodynamic instability
Penetrating trauma such as stab or gunshot wounds
Injury occurring more than 24 hours before emergency department presentation
Transfer from outside hospital with prior abdominal CT, diagnostic peritoneal lavage, or laparotomy
Transfer from outside hospital 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 visit

Research Team

James F Holmes, MD, MPH

Nathan Kuppermann, MD, MPH

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