Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma
This study is enrolling participants by invitation only.
Sponsor:
University of California, Davis
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01540318
First received: January 31, 2012
Last updated: February 27, 2012
Last verified: February 2012
| Tracking Information | |||||
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| First Received Date ICMJE | January 31, 2012 | ||||
| Last Updated Date | February 27, 2012 | ||||
| Start Date ICMJE | February 2012 | ||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Rate of Abdominal CT Scan [ Time Frame: One week from enrollment ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01540318 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma | ||||
| Official Title ICMJE | Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma | ||||
| Brief 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. The proposal's objectives are to compare the following variables in those that randomize to abdominal ultrasound versus those that do not:
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE | Abdominal Injuries | ||||
| Intervention ICMJE | Procedure: Abdominal Ultrasound (FAST examination)
Use of FAST abdominal ultrasound exam
Other Name: Focused Assesment with Sonography for Trauma |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 916 | ||||
| Estimated Completion Date | October 2014 | ||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01540318 | ||||
| Other Study ID Numbers ICMJE | 244545-4, H34MC19682 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University of California, Davis | ||||
| Study Sponsor ICMJE | University of California, Davis | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Davis | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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