Blunt Trauma to AbdomenFASTNCT05910567
A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
A study testing Focused Assessment with Sonography for Trauma (FAST) Examination in people with Blunt Trauma to Abdomen and Wounds and Injuries, run by University of California, Davis at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Blunt Trauma to Abdomen, Wounds and Injuries, Abdomen Injury
- What is being tested?
- Focused Assessment with Sonography for Trauma (FAST) Examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,650 participants
- Where
- 6 sitesUnited States
- Study dates
- 17 Apr 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Emory University Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Claudia R Morris, MD, 404-727-5500, claudia.r.morris@emory.edu
Claudia R Morris, MD
- Recruiting
University of Colorado, Anschutz Medical Center and Children's Hospital Colorado
Aurora, Colorado, 80045
Hiu Lam, MD, 708-790-1185, Hiu.Lam@childrenscolorado.org
Hiu Lam, MD
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Timothy Brenkert, MD, 513-803-2570, Timothy.Brenkert@cchmc.org
Timothy Brenkert, MD
- Recruiting
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
Delia L Gold, MD, 614-722-4385, delia.gold@nationwidechildrens.org
Delia L Gold, MD
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Bethsabee Stone, MD, 214-648-3111, Bethsabee.Stone@utsouthwestern.edu
Bethsabee Stone, MD
- Recruiting
University of California, Davis Medical Center
Sacramento, California, 95817
Maria Marois, PhD, MPH, 916-734-0373, mtmarois@ucdavis.edu
Amia Andrade, MPH, 916-703-5652, anandrade@ucdavis.edu
About this study
Official title: A Randomized Controlled Trial 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 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.
Read the 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 standard for diagnosing intra-abdominal injury, it is associated with ionizing radiation, inducing malignancies at an estimated rate of 1 per 500 abdominal CT scans in children <5 years and 1 per 600 scans in adolescents. Thus, CT use should be limited to those at non-negligible risk of intra-abdominal injury.
The Focused Assessment with Sonography for Trauma (FAST) examination has also evolved as a diagnostic test for the evaluation for intra-abdominal injury; however, it is used primarily in adults. The FAST examination uses abdominal ultrasonography to detect the presence of intraperitoneal fluid in injured patients. If intraperitoneal fluid is identified following a traumatic injury, this fluid is presumed to be blood (hemoperitoneum). The FAST examination for detection of hemoperitoneum in trauma consists of several images. These include a right hepatorenal interface (Morison's pouch), perisplenic view, and longitudinal and transverse views of the pelvis.
Potential advantages of initial ED evaluation of the injured child using the FAST examination include: 1) bedside evaluation during initial patient ED evaluation and resuscitation; 2) rapid completion of the diagnostic test (within 3-5 minutes); 3) performance of the test and interpretation of results by ED physicians or trauma surgeons caring for the child; 4) no radiation exposure; and 5) reduced patient-care costs compared to routine use of abdominal CT. In adults, a positive FAST examination is the best predictor of intra-abdominal injury. In two adult randomized controlled trials, the use of FAST demonstrated improved patient care by decreasing abdominal CT use, complications and costs. Although the sensitivity of the FAST exam for intra-abdominal injury is lower than CT, as a screening test, it may decrease the need for abdominal CT in both low risk injured adults and children.
The long-term objective of this research study 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. The specific aims of this proposal are to: 1) perform a randomized, controlled trial of the FAST examination in injured children and compare the frequency of abdominal CT scanning between children who are randomized to the FAST and non-FAST arms; 2) identify if an evaluation strategy including the FAST examination results in a similar frequency of missed or delayed diagnoses of intra-abdominal injuries than a strategy without the FAST examination; and 3) identify patient, physician, and system factors associated with obtaining abdominal CT scans in patients considered low risk for intra-abdominal injuries by the clinician after a negative FAST examination. Such a study has the potential for significant impact in improving the lives of injured children, if found to be successful.
This randomized controlled trial will follow the methods of the one prior randomized controlled trial of FAST in injured children which enrolled 925 injured children at a single center. This study incorporate a total of six centers to increase the sample size and generalizability of the results.
- Conditions
- Blunt Trauma to Abdomen, Wounds and Injuries, Abdomen Injury, Abdominal Injury, Abdomen, Acute
- Being tested
- Focused Assessment with Sonography for Trauma (FAST) Examination, No Intervention: Standard of Care - Without the FAST Examination
- Keywords
- Child, Wounds and Injuries, Blunt Trauma to Abdomen, Abdomen Injury, Blunt Abdominal Trauma
- Medical subject headings
- Wounds and Injuries, Abdominal Injuries, Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Assessment with Sonography for Trauma (FAST) ExaminationDiagnostic test
Also called Abdominal Ultrasound
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 ExaminationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Focused Assessment with Sonography for Trauma (FAST) Examination Arm | Other | 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. Receives: Diagnostic Test: Focused Assessment with Sonography for Trauma (FAST) Examination |
| No Intervention - Standard of Care - Without the FAST Examination | Other | Institution will use their standard operating procedures to deliver the usual care for injured patients with blunt abdominal/torso trauma. Receives: Other: No Intervention: Standard of Care - Without the FAST Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of abdominal CT scanning
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
Secondary outcomes (5)
Emergency Department (ED) length of stay
ED length of stay is a continuous variable measured in minutes. The investigators will compare the ED length of stay between study arms using nonparametric methods (time from ED arrival to hospital admission or time from ED arrival until ED discharge).
Measured: ED length of stay will be calculated in minutes from the time of ED arrival until the time of ED discharge or the time from ED arrival until the time of hospital admission assessed up to 7 days.
Rate of Hospitalization
Rate of hospitalization is a categorical variable (yes/no) on whether the patient is hospitalized on initial, enrolling ED visit. The investigators will compare the rate of hospitalization between study arms using categorical statistical methods.
Measured: The assessment of the categorical variable yes/no will occur upon the participants discharge from the Emergency Department or admission to the hospital, an average of 6.5 hours
Physician suspicion of intra-abdominal injury
Physician suspicion of intra-abdominal injury is collected after initial physician evaluation for all patients. For those patients who are randomized to the FAST examination this information is collected again after completing the FAST examination. Physician suspicion is collected as follows: Less than 1%, 1-5%, 6-10%, 11-50%, greater than 50%.
Measured: All physician suspicion assessments will occur up to 24 hours after a participants ED presentation
Rate of abdominal CT scanning in children 0 to 3 years of age.
In this prespecified age group, the 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).
Measured: For the duration of the subject's Emergency Department stay and initial hospitalization (up to 24 hours).
Laparotomy (surgery to the abdomen) rate
Laparotomy rate is a binary indicator (yes/no) for whether the patient underwent a laparotomy (surgery to the abdomen) to identify/repair an intra-abdominal injury.
Measured: For the first seven days after the time of injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start17 Apr 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blunt Trauma to AbdomenStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients meeting enrollment criteria will be randomized to the FAST examination arm or to a standard of care/non-FAST examination arm using computer randomized order of enrollment. Randomization will be stratified by site and age group. Age groups will consist of participants 0 to their 3rd birthday and participants 3 years of age up to their 18th birthday. A minimum of 794 participants will be enrolled in the 0 to younger than 3 years of age group. To ensure concealment, opaque envelopes will be prepared at each study site using the randomization scheme provided by the lead institution. These envelopes will be readily available in the ED, provide the investigator with the randomized assignment, and contain the appropriate data collection form.
- Masking
- None (open label)
- Enrolment
- 4,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Emergency Care Applied Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- James F Holmes, MD, MPH, Principal investigator, University of California, DavisNathan Kuppermann, MD, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910567
- Sponsor's protocol ID
- 1943798
- Other IDs
- R01HD102571
- Acronym
- FAST
- Status last verified
- Aug 2026
- First submitted
- 9 May 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmes JF, Tancredi DJ, Kelley KM, Griffiths M, Gold DL, Lam SHF, Stone B, Brenkert T, Andrade AN, Hanson E, Gwal K, Kornblith A, Hirose S, Utter GH, Kuppermann N. Abdominal ultrasound (FAST) in hemodynamically stable children with blunt abdominal trauma: study protocol for a randomized controlled trial. Trials. 2025 Dec 12;26(1):564. doi: 10.1186/s13063-025-09137-6.
PubMed 41388553
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
- ClinicalTrials.gov ID
- NCT05910567
- Acronym / sponsor ID
- FAST / 1943798
- Conditions
- Blunt Trauma to Abdomen, Wounds and Injuries, Abdomen Injury, Abdominal Injury, Abdomen, Acute
- Keywords
- Child, Wounds and Injuries, Blunt Trauma to Abdomen, Abdomen Injury, Blunt Abdominal Trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,650 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Pediatric Emergency Care Applied Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 standard for diagnosing intra-abdominal injury, it is associated with ionizing radiation, inducing malignancies at an estimated rate of 1 per 500 abdominal CT scans in children <5 years and 1 per 600 scans in adolescents. Thus, CT use should be limited to those at non-negligible risk of intra-abdominal injury.
The Focused Assessment with Sonography for Trauma (FAST) examination has also evolved as a diagnostic test for the evaluation for intra-abdominal injury; however, it is used primarily in adults. The FAST examination uses abdominal ultrasonography to detect the presence of intraperitoneal fluid in injured patients. If intraperitoneal fluid is identified following a traumatic injury, this fluid is presumed to be blood (hemoperitoneum). The FAST examination for detection of hemoperitoneum in trauma consists of several images. These include a right hepatorenal interface (Morison's pouch), perisplenic view, and longitudinal and transverse views of the pelvis.
Potential advantages of initial ED evaluation of the injured child using the FAST examination include: 1) bedside evaluation during initial patient ED evaluation and resuscitation; 2) rapid completion of the diagnostic test (within 3-5 minutes); 3) performance of the test and interpretation of results by ED physicians or trauma surgeons caring for the child; 4) no radiation exposure; and 5) reduced patient-care costs compared to routine use of abdominal CT. In adults, a positive FAST examination is the best predictor of intra-abdominal injury. In two adult randomized controlled trials, the use of FAST demonstrated improved patient care by decreasing abdominal CT use, complications and costs. Although the sensitivity of the FAST exam for intra-abdominal injury is lower than CT, as a screening test, it may decrease the need for abdominal CT in both low risk injured adults and children.
The long-term objective of this research study 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. The specific aims of this proposal are to: 1) perform a randomized, controlled trial of the FAST examination in injured children and compare the frequency of abdominal CT scanning between children who are randomized to the FAST and non-FAST arms; 2) identify if an evaluation strategy including the FAST examination results in a similar frequency of missed or delayed diagnoses of intra-abdominal injuries than a strategy without the FAST examination; and 3) identify patient, physician, and system factors associated with obtaining abdominal CT scans in patients considered low risk for intra-abdominal injuries by the clinician after a negative FAST examination. Such a study has the potential for significant impact in improving the lives of injured children, if found to be successful.
This randomized controlled trial will follow the methods of the one prior randomized controlled trial of FAST in injured children which enrolled 925 injured children at a single center. This study incorporate a total of six centers to increase the sample size and generalizability of the results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients meeting enrollment criteria will be randomized to the FAST examination arm or to a standard of care/non-FAST examination arm using computer randomized order of enrollment. Randomization will be stratified by site and age group. Age groups will consist of participants 0 to their 3rd birthday and participants 3 years of age up to their 18th birthday. A minimum of 794 participants will be enrolled in the 0 to younger than 3 years of age group. To ensure concealment, opaque envelopes will be prepared at each study site using the randomization scheme provided by the lead institution. These envelopes will be readily available in the ED, provide the investigator with the randomized assignment, and contain the appropriate data collection form.
| Arm | Type | Receives |
|---|---|---|
| Focused Assessment with Sonography for Trauma (FAST) Examination Arm | Other | Diagnostic Test: Focused Assessment with Sonography for Trauma (FAST) ExaminationPatients 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. |
| No Intervention - Standard of Care - Without the FAST Examination | Other | Other: No Intervention: Standard of Care - Without the FAST ExaminationInstitution will use their standard operating procedures to deliver the usual care for injured patients with blunt abdominal/torso trauma. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Blunt torso trauma resulting from a significant mechanism of injury:
- 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):
- History and physical examination suggestive of blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)
Key exclusion criteria (12 listed)
- Age-adjusted low blood pressure (Hemodynamic instability)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused Assessment with Sonography for Trauma (FAST) ExaminationAlso: Abdominal UltrasoundA bedside Focused Assessment with Sonography for Trauma (FAST) Examination will be conducted on those participants who are randomized to the FAST arm. | Diagnostic test | Focused Assessment with Sonography for Trauma (FAST) Examination Arm |
| No Intervention: Standard of Care - Without the FAST ExaminationParticipants 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. | Other | No Intervention - Standard of Care - Without the FAST Examination |
Primary outcome
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).
5 secondary outcomes
Emergency Department (ED) length of stay
Time frame: ED length of stay will be calculated in minutes from the time of ED arrival until the time of ED discharge or the time from ED arrival until the time of hospital admission assessed up to 7 days.
Rate of Hospitalization
Time frame: The assessment of the categorical variable yes/no will occur upon the participants discharge from the Emergency Department or admission to the hospital, an average of 6.5 hours
Physician suspicion of intra-abdominal injury
Time frame: All physician suspicion assessments will occur up to 24 hours after a participants ED presentation
Rate of abdominal CT scanning in children 0 to 3 years of age.
Time frame: For the duration of the subject's Emergency Department stay and initial hospitalization (up to 24 hours).
Laparotomy (surgery to the abdomen) rate
Time frame: For the first seven days after the time of injury.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 41388553Holmes JF, Tancredi DJ, Kelley KM, Griffiths M, Gold DL, Lam SHF, Stone B, Brenkert T, Andrade AN, Hanson E, Gwal K, Kornblith A, Hirose S, Utter GH, Kuppermann N. Abdominal ultrasound (FAST) in hemodynamically stable children with blunt abdominal trauma: study protocol for a randomized controlled trial. Trials. 2025 Dec 12;26(1):564. doi: 10.1186/s13063-025-09137-6.
- Pediatric Emergency Care Applied Research NetworkLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Blunt Trauma to Abdomen
Not yet recruitingObservational study
Medical,Nursing Record,PE, Blood Test and Radiological Examination ,Morality and Mobility of Multiple Trauma Patient
Trauma Centers/Statistics & Numerical Data, Trauma Blunt
RecruitingObservational study
Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients
Abdominal Injury, Pelvic Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James F Holmes, MD, MPH principal investigator
University of California, Davis
Nathan Kuppermann, MD, MPH principal investigator
University of California, Davis
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Assessment with Sonography for Trauma (FAST) Examination in people with Blunt Trauma to Abdomen and Wounds and Injuries, run by University of California, Davis at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James F Holmes, MD, MPH (916-734-1533, jfholmes@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05910567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.