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NCT05910567 · ClinicalTrials.gov registry record · NA
A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
A NA study of Wounds and Injuries and Abdominal Injury, sponsored by University of California, Davis.
- Recruiting
- Registry status
- NA
- Development phase
- 4,346
- Enrollment target
- 6
- Study locations
NCT05910567: Recruiting NA study of Wounds and Injuries and Abdominal Injury, sponsored by University of California, Davis.
NCT05910567 is a NA study of Wounds and Injuries and Abdominal Injury that is actively recruiting participants, run by University of California, Davis. The registered enrollment target is 4,346 participants, above the 343-participant average among 27 other Wounds and Injuries trials with a reported enrollment target (1167% higher). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05910567, a NA study of Wounds and Injuries and Abdominal Injury, is actively recruiting participants, sponsored by University of California, Davis.
- RECRUITING
- Registry status
- NA
- Development phase
- 4,346 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
The primary outcome is the rate of abdominal CT scanning in each study arm, measured for each patient categorically (yes/no) during the Emergency Department stay and initial hospitalization (up to 24 hours).
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Focused Assessment with Sonography for Trauma (FAST) Examination
- OTHER No Intervention: Standard of Care - Without the FAST Examination
Study Locations (6)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- The Research Institute at Nationwide Children's Hospital - Columbus
California
- University of California, Davis Medical Center - Sacramento
Colorado
- University of Colorado, Anschutz Medical Center and Children's Hospital Colorado - Aurora
Georgia
- Emory University Children's Healthcare of Atlanta - Atlanta
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,346 participants |
| Start Date | 2023-04-17 |
| Est. Completion | 2027-04-30 |
| Phase | NA |
What NCT05910567 shows while recruiting
NCT05910567 is an interventional study that assigns participants to a tested intervention. Its 4,346 participants enrollment target places it among the larger protocols in the corpus, above the 343-participant average among 27 other Wounds and Injuries trials with a reported enrollment target (1167% higher).
The record links to 5 conditions, with Wounds and Injuries appearing as the primary indexed condition, and to 2 interventions - of which Focused Assessment with Sonography for Trauma (FAST) Examination is the first listed.
NCT05910567 lists 6 locations in 5 states (Ohio, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT05910567 about?
NCT05910567 is a clinical study titled "A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma". 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 t...
What is the current status of trial NCT05910567?
This trial is currently recruiting. It is a NA study. The enrollment target is 4,346 participants. The study started on 2023-04-17. Estimated completion is 2027-04-30.
What conditions does trial NCT05910567 study?
This clinical trial studies the following conditions: Wounds and Injuries, Abdominal Injury, Blunt Trauma to Abdomen, Abdomen Injury, Abdomen, Acute.
What interventions are being tested in trial NCT05910567?
The interventions under investigation include: Focused Assessment with Sonography for Trauma (FAST) Examination (DIAGNOSTIC_TEST), No Intervention: Standard of Care - Without the FAST Examination (OTHER).
Who is sponsoring clinical trial NCT05910567?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05910567 being conducted?
This trial has 6 study locations across California, Colorado, Georgia, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05910567's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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