Status:

RECRUITING

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

Lead Sponsor:

University of California, Davis

Collaborating Sponsors:

Pediatric Emergency Care Applied Research Network

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Conditions:

Blunt Trauma to Abdomen

Wounds and Injuries

Eligibility:

All Genders

Up to 17 years

Phase:

NA

Brief 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...

Detailed Description

Trauma is a leading cause of death in children in the US. Abdominal trauma accounts for 30% of all pediatric traumatic deaths, second only to traumatic brain injury. Although CT is the reference stand...

Eligibility Criteria

Children younger than 18 years of age (0 to 17.9999 years) with blunt abdominal trauma presenting to the participating EDs within 24 hours of the traumatic event will be eligible if the do not meet any exclusion criteria and meet any one of the following inclusion criteria.

Inclusion Criteria:

  1. Blunt torso trauma resulting from a significant mechanism of injury:

    • Motor vehicle collision: greater than 60 mph, ejection, or rollover
    • Automobile versus pedestrian/bicycle: automobile speed > 25 mph
    • Falls greater than 20 feet in height
    • Crush injury to the torso
    • Physical assault involving the abdomen
  2. Decreased level of consciousness (Glasgow Coma Scale (GCS) score 9-14 or below age-appropriate behavior) in association with blunt torso trauma

  3. Blunt traumatic event with any of the following (regardless of the mechanism):

    • Extremity paralysis
    • Multiple long bone fractures (e.g., tibia and humerus fracture)
  4. History and physical examination suggestive of blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)

Exclusion Criteria:

The following patients will be excluded from the study:

  1. Age-adjusted low blood pressure (Hemodynamic instability)

    • Patients will be excluded for prehospital or initial age-adjusted ED low blood pressure. This is because the standard evaluation of these patients involves immediate FAST based on prior work by our group. Low blood pressure is determined based upon the patient's age, and will be defined as a systolic blood pressure less than 70 mm Hg for patients younger than 1 month, less than 80 mm Hg for ages 1 month to 5 years, and less than 90 mm Hg for ages over 5 years.
  2. Penetrating trauma: Patients who are victims of stab or gunshot wounds

  3. Traumatic injury occurring > 24 hours prior to the time of presentation to the ED

  4. Transfer of the patient to the ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed

  5. Transferred with FAST exam already performed at outside hospital

  6. Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts

  7. Initial GCS score ≤ 8 as it is standard for children with GCS scores ≤ 8 to undergo abdominal CT if blunt abdominal trauma is suspected

  8. Known pregnancy

  9. Known prisoner

  10. Known intra-abdominal injury diagnosed within 30 days prior of this ED visit

Key Trial Info

Start Date :

April 17 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 30 2027

Estimated Enrollment :

4346 Patients enrolled

Trial Details

Trial ID

NCT05910567

Start Date

April 17 2023

End Date

April 30 2027

Last Update

December 11 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

University of California, Davis Medical Center

Sacramento, California, United States, 95817

2

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

Aurora, Colorado, United States, 80045

3

Emory University Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30322

4

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229