NCT05910567 · University of California, Davis
A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
(FAST)
What this study 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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Focused Assessment with Sonography for Trauma (FAST) Examination
A bedside Focused Assessment with Sonography for Trauma (FAST) Examination will be conducted on those participants who are randomized to the FAST arm.
OTHER
No Intervention: Standard of Care - Without the FAST Examination
Participants randomized to usual care will be evaluated per the standard operating procedures of the institution/site for the condition under study without the FAST exam.
Primary outcome measures
Rate of abdominal CT scanning
Time frame: For the duration of the subject's Emergency Department stay and initial hospitalization (up to 24 hours)
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).
Rate of delayed or missed or delayed intra-abdominal injuries
Time frame: In hospitalized participants, IAI collection will be captured from the time of assignment until discharge (up to 30 days). For participants discharged from the ED IAI collection will be captured from the time of assignment until 7 days after ED discharge
The rate of missed or delayed intra-abdominal injuries (IAI) will be identified and reported for any cases with a delay in diagnosis (i.e., patients diagnosed with IAI in the hospital after ED disposition) or missed IAI (IAI diagnosed after discharge from the ED/hospital).
Identifying variables associated with obtaining abdominal CT scans in very low risk patients with normal FAST examinations
Time frame: The binary indicator assessment of yes/no will occur upon discharge from the Emergency Department or admission to the hospital, an average of 6.5 hours
This primary outcome will be a binary indicator (yes/no) for whether the patient with a normal FAST examination who is thought by the clinician to have less than a 1% risk of intra-abdominal injury nonetheless undergoes abdominal CT (outcome of interest).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Sacramento, California
- Aurora, Colorado
- Atlanta, Georgia
- Cincinnati, Ohio
- Columbus, Ohio
- Dallas, Texas
Collaborators
Pediatric Emergency Care Applied Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 11, 2025 · Source of record for eligibility and locations