Systematic Review and Meta-Analysis of Venous Thromboembolism (VTE) Risk Assessment in Hospitalized Medical Patients
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| First Received Date ICMJE | October 3, 2011 | ||||
| Last Updated Date | April 17, 2012 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
VTE [ Time Frame: 28 to 180 days ] [ Designated as safety issue: No ] Objectively confirmed within individual studies |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01446510 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Systematic Review and Meta-Analysis of Venous Thromboembolism (VTE) Risk Assessment in Hospitalized Medical Patients | ||||
| Official Title ICMJE | Systematic Review and Meta-Analysis of Venous Thromboembolism Risk Assessment Models in Hospitalized Medical Patients | ||||
| Brief Summary | A systematic review and meta analysis will be performed of risk assessment models for Venous thromboembolism ("VTE" including pulmonary embolism "PE" and deep venous thrombosis "DVT")in hospitalized medical patients. The goal of this study is to evaluate whether the incidence of VTE is lower in patients that are evaluated with a risk assessment model and treated with thromboprophylaxis for their assigned level of risk. |
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| Detailed Description | Venous thromboembolism ("VTE" including pulmonary embolism "PE" and deep venous thrombosis "DVT") is associated with significant morbidity and mortality. Only about half of eligible hospitalized medical patients receive appropriate thromboprophylaxis. Understanding VTE risk factors predictive of VTE among hospitalized medical patients may promote superior thromboprophylaxis. To date a systematic review of VTE risk assessment strategies among hospitalized medical patients, and a meta-analysis reporting the rate of VTE among patient groups at varying levels of risk for VTE does not exist. The investigators will use the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) checklist for reporting systematic reviews and meta-analyses to develop this systematic review and meta-analysis. The investigators will perform a systematic review of the literature and report VTE risk assessment models that have been derived and validated among hospitalized medical patients. The investigators will perform a meta-analysis of studies that report a rate of VTE among patients identified as being at elevated risk for VTE and those that are not. The investigators pre-specify that they are going to analyze the prospective and retrospective studies captured by the literature search in two ways. First, the investigators will perform an analysis that groups both prospective and retrospective studies together. The investigators will also perform an analysis that separates out the prospective and retrospective studies. While this will decrease our sample size (and thus power), this approach may allow us to identify any bias or confounding present due to the retrospective study design and then control for it. Notably confirmation that both retrospective and prospective studies identified the same findings would enhance the clinical usefulness of our findings. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult hospitalized medical patients |
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| Condition ICMJE | Venous Thromboembolism | ||||
| Intervention ICMJE | Other: Application of VTE Risk Assessment
Use of a method to assess a patient's risk of VTE, and then appropriate prophylaxis for the assigned level of risk |
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| Study Group/Cohort (s) | Hospitalized Medical Patients
All hospitalized medical adult patients
Intervention: Other: Application of VTE Risk Assessment |
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| Publications * |
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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 | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Estimated Completion Date | April 2013 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01446510 | ||||
| Other Study ID Numbers ICMJE | VTERiskMA8011 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Intermountain Health Care, Inc. | ||||
| Study Sponsor ICMJE | Intermountain Health Care, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Intermountain Health Care, Inc. | ||||
| Verification Date | September 2011 | ||||
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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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