Systematic Review and Meta-Analysis of Venous Thromboembolism (VTE) Risk Assessment in Hospitalized Medical Patients
Primary Purpose
Venous Thromboembolism
Status
Withdrawn
Phase
Locations
United States
Study Type
Observational
Intervention
Application of VTE Risk Assessment
Sponsored by
About this trial
This is an observational trial for Venous Thromboembolism focused on measuring VTE, DVT, PE, Risk assessment, risk score, risk analysis, Venous thromboembolism risk
Eligibility Criteria
Inclusion Criteria:
- Adults
- Hospitalized
Exclusion Criteria:
- Surgical patients
- Pregnant patients
Sites / Locations
- Intermountain Medical Center
Arms of the Study
Arm 1
Arm Type
Arm Label
Hospitalized Medical Patients
Arm Description
All hospitalized medical adult patients
Outcomes
Primary Outcome Measures
VTE
Objectively confirmed within individual studies
Secondary Outcome Measures
Full Information
NCT ID
NCT01446510
First Posted
October 3, 2011
Last Updated
April 17, 2012
Sponsor
Intermountain Health Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01446510
Brief Title
Systematic Review and Meta-Analysis of Venous Thromboembolism (VTE) Risk Assessment in Hospitalized Medical Patients
Official Title
Systematic Review and Meta-Analysis of Venous Thromboembolism Risk Assessment Models in Hospitalized Medical Patients
Study Type
Observational
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Withdrawn
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
VTE, DVT, PE, Risk assessment, risk score, risk analysis, Venous thromboembolism risk
7. Study Design
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hospitalized Medical Patients
Arm Description
All hospitalized medical adult patients
Intervention Type
Other
Intervention Name(s)
Application of VTE Risk Assessment
Intervention Description
Use of a method to assess a patient's risk of VTE, and then appropriate prophylaxis for the assigned level of risk
Primary Outcome Measure Information:
Title
VTE
Description
Objectively confirmed within individual studies
Time Frame
28 to 180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults
Hospitalized
Exclusion Criteria:
Surgical patients
Pregnant patients
Study Population Description
Adult hospitalized medical patients
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott C Woller, MD
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19622552
Citation
Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009 Jul 21;339:b2700. doi: 10.1136/bmj.b2700.
Results Reference
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PubMed Identifier
18574271
Citation
Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656.
Results Reference
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PubMed Identifier
15855435
Citation
Quiroz R, Kucher N, Zou KH, Kipfmueller F, Costello P, Goldhaber SZ, Schoepf UJ. Clinical validity of a negative computed tomography scan in patients with suspected pulmonary embolism: a systematic review. JAMA. 2005 Apr 27;293(16):2012-7. doi: 10.1001/jama.293.16.2012.
Results Reference
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Systematic Review and Meta-Analysis of Venous Thromboembolism (VTE) Risk Assessment in Hospitalized Medical Patients
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