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:
-
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
-
Decreased level of consciousness (Glasgow Coma Scale (GCS) score 9-14 or below age-appropriate behavior) in association with blunt torso trauma
-
Blunt traumatic event with any of the following (regardless of the mechanism):
- Extremity paralysis
- Multiple long bone fractures (e.g., tibia and humerus fracture)
-
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:
-
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.
-
Penetrating trauma: Patients who are victims of stab or gunshot wounds
-
Traumatic injury occurring > 24 hours prior to the time of presentation to the ED
-
Transfer of the patient to the ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed
-
Transferred with FAST exam already performed at outside hospital
-
Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts
-
Initial GCS score ≤ 8 as it is standard for children with GCS scores ≤ 8 to undergo abdominal CT if blunt abdominal trauma is suspected
-
Known pregnancy
-
Known prisoner
-
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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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