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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 22, 2005 | ||||||||
| Last Updated Date | September 23, 2009 | ||||||||
| Start Date ICMJE | June 2005 | ||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00228111 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | TRACT Study: Evaluation of the Value of Routine Thoraco-abdominal CT in Blunt Trauma Patients | ||||||||
| Official Title ICMJE | Prospective Evaluation of the Additional Value of Routine Thoraco-abdominal CT in Patients That Suffered Severe Blunt Trauma of the Abdomen/Thorax | ||||||||
| Brief Summary | The aim of this study is to establish the additional effectiveness and costs of routine thoraco-abdominal computed tomography (CT) in blunt trauma patients versus conventional radiological imaging and to determine which clinical parameters predict a high additional value of routine thoraco-abdominal CT. |
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| Detailed Description | The technological advances in computed tomography (CT), with faster image acquisition resulting in higher resolution, result in making CT a more widely and intensively used imaging modality in trauma patient care. Thoraco-abdominal CT in addition appears to have additional diagnostic value compared to conventional radiography, especially in severely injured trauma patients. Nowadays, both clinical data and conventional radiology are used to determine which patient should undergo body CT scanning. Currently there are no widely accepted guidelines for the use of a "standard" TRAuma CT (TRACT). Although many retrospective and several prospective cohort studies have been published on this topic, the data are not sufficient to sustain evidence-based practice in decision-making. The aim of this study is, to establish the additional effectiveness and costs of routine thoraco-abdominal CT in blunt trauma patients versus conventional radiological imaging and to determine which clinical parameters predict a high additional value of routine thoraco-abdominal CT. Consecutive trauma patients, who are at least 16 years old and are suffering from severe injuries, undergo a standard trauma CT of the cervical spine, the thorax and abdomen after clinical evaluation and conventional radiological workup. Clinical, conventional and computed tomographic radiological assessment, costs, therapeutic consequences and 6 months patient follow up are recorded and will be statistically analyzed. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 1000 | ||||||||
| Completion Date | December 2008 | ||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 16 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00228111 | ||||||||
| Responsible Party | Radboud University Medical Centre | ||||||||
| Study ID Numbers ICMJE | 2005/093 | ||||||||
| Study Sponsor ICMJE | Radboud University | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Radboud University | ||||||||
| Verification Date | September 2009 | ||||||||
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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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