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| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | August 24, 2007 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00204204 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Importance of Forces and Safety Features in Car Crash Multitrauma | ||||
| Official Title ICMJE | The Multitraumatized Patient. What is the Importance of Forces Involved and the Use of Safety Equipment for the Amount of Trauma to the Patient Inside the Vehicle. | ||||
| Brief Summary | The pupose of the study is a prospective evaluation of external and internal factors/causes of importance for the trauma and final outcome experienced by persons inside motor vehicles in serious car accidents. We hypothesise that there is an association between the use and function of safety features and the results for the patient and an association between material damage and the severity of injury. |
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| Detailed Description | We plan to study approximately 200 road accidents with multitraumatised patients and accidents with modern cars and severe material damage with little or moderate damage to persons inside the vehicle. A researcher will be alerted by the call centre (Norwegian 911-equivalent), move to the place of accident and take a pure observers role (unless ethically unacceptable due to lack of other health personnel). He will document the accident including use and condition of safety features, conditions inside the coupe, weather conditions, etc. Other available information on the vehicles, crashtests etc will be gathered from the manufacturer. All medical information will be gathered from the ambulance service, hospitals, pathology and forensic departments. Information from police and fire department will also be gathered. Patient, next-of-kin, others invloved will be interviewed as appropriate in follow-up. Four accident groups: Front-to-front or -object > 60 km/hour, same < 60 km/hour, car rolled over on road, car rolled over out-of-road. Factors: Age of vehicle, damage to coupe, cause of accident, on-scene time, initial evaluation by health personnel, injury severity scoring in hospital. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History, Cross-Sectional, Defined Population, Prospective Study | ||||
| Condition ICMJE | Multiple Trauma | ||||
| 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 | ||||
| Enrollment ICMJE | 200 | ||||
| Completion Date | January 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00204204 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 216-05-04273, 200500715-2 | ||||
| Study Sponsor ICMJE | University of Oslo | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Oslo | ||||
| Verification Date | August 2007 | ||||
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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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