Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Systematic Review and Meta-Analysis of Venous Thromboembolism (VTE) Risk Assessment in Hospitalized Medical Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01446510
First received: October 3, 2011
Last updated: April 17, 2012
Last verified: September 2011
  Purpose

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.


Condition Intervention
Venous Thromboembolism
Other: Application of VTE Risk Assessment

Study Type: Observational
Official Title: Systematic Review and Meta-Analysis of Venous Thromboembolism Risk Assessment Models in Hospitalized Medical Patients

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • VTE [ Time Frame: 28 to 180 days ] [ Designated as safety issue: No ]
    Objectively confirmed within individual studies


Enrollment: 0
Study Start Date: September 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hospitalized Medical Patients
All hospitalized medical adult patients
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult hospitalized medical patients

Criteria

Inclusion Criteria:

  • Adults
  • Hospitalized

Exclusion Criteria:

  • Surgical patients
  • Pregnant patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446510

Locations
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
Study Director: Scott C Woller, MD Intermountain Health Care, Inc.
  More Information

Publications:
Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01446510     History of Changes
Other Study ID Numbers: VTERiskMA8011
Study First Received: October 3, 2011
Last Updated: April 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
VTE
DVT
PE
Risk assessment
risk score
risk analysis
Venous thromboembolism risk

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014