Abdominal InjuriesNCT01540318
Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma
A study testing Abdominal Ultrasound (FAST examination) in people with Abdominal Injuries, run by University of California, Davis at 1 site in United States.
Trial summary
The major goal of this project is to conduct a randomized controlled trial studying an initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal ultrasound for the evaluation of children with blunt abdominal trauma. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Abdominal Injuries
- What is being tested?
- Abdominal Ultrasound (FAST examination)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 925 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
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- Decreased level of consciousness (Glasgow Coma Scale score < 15 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 intra-abdominal injury following blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)
Who cannot join
- No concern for inter-abdominal injury or no planned evaluation for possible IAI
- Prehospital or ED age adjusted Hypotension
- Prehospital or initial ED GCS score ≤ 8
- Presence of an abdominal "seat belt sign" - continuous area of erythema/contusion completely across the lower abdomen secondary to a lap belt
- Penetrating trauma: stab or gunshot wounds
- Traumatic injury occurring > 24 hours prior to the time of presentation to the ED
- Transfer of the patient to the UCDMC ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed
- Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
The major goal of this project is to conduct a randomized controlled trial studying an initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's objectives are to compare the following variables in those that randomize to abdominal ultrasound versus those that do not:
- rate of abdominal CT scanning
- time to emergency department disposition
- the rate of missed/delayed diagnosis of intra-abdominal injury
- the costs.
- Conditions
- Abdominal Injuries
- Being tested
- Abdominal Ultrasound (FAST examination)
- Keywords
- ultrasonography, Abdominal Injuries, Trauma
- Medical subject headings
- Abdominal Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Ultrasound (FAST examination)Procedure or surgery
Also called Focused Assesment with Sonography for Trauma
Use of FAST abdominal ultrasound exam
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Ultrasound | Experimental | Patients in the experimental arm will receive a "Focused Assessment with Sonography for Trauma (FAST)" which includes the use of abdominal ultrasound. Receives: Procedure: Abdominal Ultrasound (FAST examination) |
| No Abdominal Ultrasound | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Abdominal CT Scan
Measured: One week from enrollment
Secondary outcomes (2)
Total time spent in the Emergency Department
Measured: 24 hours from enrollment
Cost effectiveness
Measured: two months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2016
- Study completionJan 2016
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 Abdominal InjuriesStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 925 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James F Holmes, MD, MPH, Principal investigator, UC Davis School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540318
- Sponsor's protocol ID
- 244545
- Other IDs
- H34MC19682, 244545
- Status last verified
- Jan 2019
- First submitted
- 31 Jan 2012
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holmes JF, Kelley KM, Wootton-Gorges SL, Utter GH, Abramson LP, Rose JS, Tancredi DJ, Kuppermann N. Effect of Abdominal Ultrasound on Clinical Care, Outcomes, and Resource Use Among Children With Blunt Torso Trauma: A Randomized Clinical Trial. JAMA. 2017 Jun 13;317(22):2290-2296. doi: 10.1001/jama.2017.6322.
PubMed 28609532
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma
- ClinicalTrials.gov ID
- NCT01540318
- Acronym / sponsor ID
- 244545
- Conditions
- Abdominal Injuries
- Keywords
- ultrasonography, Abdominal Injuries, Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 925 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Feb 2012 (estimated)
- 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.
The major goal of this project is to conduct a randomized controlled trial studying an initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's objectives are to compare the following variables in those that randomize to abdominal ultrasound versus those that do not:
- rate of abdominal CT scanning
- time to emergency department disposition
- the rate of missed/delayed diagnosis of intra-abdominal injury
- the costs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Ultrasound | Experimental | Procedure: Abdominal Ultrasound (FAST examination)Patients in the experimental arm will receive a "Focused Assessment with Sonography for Trauma (FAST)" which includes the use of abdominal ultrasound. |
| No Abdominal Ultrasound | No intervention | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Blunt torso trauma resulting from a significant mechanism of injury
- Blunt traumatic event with any of the following (regardless of the mechanism):
- History and physical examination suggestive of intra-abdominal injury following blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)
Key exclusion criteria (8 listed)
- No concern for inter-abdominal injury or no planned evaluation for possible IAI
- Prehospital or ED age adjusted Hypotension
- Prehospital or initial ED GCS score ≤ 8
- Presence of an abdominal "seat belt sign" - continuous area of erythema/contusion completely across the lower abdomen secondary to a lap belt
- Penetrating trauma: stab or gunshot wounds
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 |
|---|---|---|
| Abdominal Ultrasound (FAST examination)Also: Focused Assesment with Sonography for TraumaUse of FAST abdominal ultrasound exam | Procedure or surgery | Abdominal Ultrasound |
Primary outcome
Rate of Abdominal CT Scan
Time frame: One week from enrollment
2 secondary outcomes
Total time spent in the Emergency Department
Time frame: 24 hours from enrollment
Cost effectiveness
Time frame: two months from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 28609532Holmes JF, Kelley KM, Wootton-Gorges SL, Utter GH, Abramson LP, Rose JS, Tancredi DJ, Kuppermann N. Effect of Abdominal Ultrasound on Clinical Care, Outcomes, and Resource Use Among Children With Blunt Torso Trauma: A Randomized Clinical Trial. JAMA. 2017 Jun 13;317(22):2290-2296. doi: 10.1001/jama.2017.6322.
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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. This study is not recruiting at the moment.
James F Holmes, MD, MPH principal investigator
UC Davis School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Ultrasound (FAST examination) in people with Abdominal Injuries, run by University of California, Davis at 1 site 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 8 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: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Abdominal CT Scan (time frame: One week from enrollment). 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 NCT01540318, 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 16 Jan 2019.