Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05910567

Conditions

Blunt Trauma to Abdomen

Wounds and Injuries

Abdomen Injury

Abdominal Injury

Abdomen, Acute

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Focused Assessment with Sonography for Trauma (FAST) Examination

No Intervention: Standard of Care - Without the FAST Examination

Study Details

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, 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.

Conditions

Blunt Trauma to Abdomen

Wounds and Injuries

Abdomen Injury

Abdominal Injury

Abdomen, Acute

Study ID

NCT05910567

Start date

Apr 17, 2023

Status verified date

Aug, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

4650 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Focused Assessment with Sonography for Trauma (FAST) Examination Arm

Patients in this arm will under the FAST examination (abdominal ultrasound) for diagnostic purposes to detect the presence of blood in injured patients with blunt abdominal trauma.

other: No Intervention - Standard of Care - Without the FAST Examination

Institution will use their standard operating procedures to deliver the usual care for injured patients with blunt abdominal/torso trauma.

Interventions

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.

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 measure

  • Rate of abdominal CT scanning [ Time Frame: For the duration of the subject's 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

James F Holmes, MD, MPH

916-734-1533jfholmes@ucdavis.edu

Nathan Kuppermann, MD, MPH

916-734-1535nkuppermann@ucdavis.edu

Locations

University of California, Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Maria Marois, PhD, MPH

916-734-0373mtmarois@ucdavis.edu

Amia Andrade, MPH

916-703-5652anandrade@ucdavis.edu

Principal Investigator:

James F Holmes, MD, MPH

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

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Hiu Lam, MD

708-790-1185Hiu.Lam@childrenscolorado.org

Principal Investigator:

Hiu Lam, MD

Emory University Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Claudia R Morris, MD

404-727-5500claudia.r.morris@emory.edu

Principal Investigator:

Claudia R Morris, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Timothy Brenkert, MD

513-803-2570Timothy.Brenkert@cchmc.org

Principal Investigator:

Timothy Brenkert, MD

The Research Institute at Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Delia L Gold, MD

614-722-4385delia.gold@nationwidechildrens.org

Principal Investigator:

Delia L Gold, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Bethsabee Stone, MD

214-648-3111Bethsabee.Stone@utsouthwestern.edu

Principal Investigator:

Bethsabee Stone, MD

More Information

Sponsor

University of California, Davis

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Child
  • Wounds and Injuries
  • Blunt Trauma to Abdomen
  • Abdomen Injury
  • Blunt Abdominal Trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-08-27.