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Retrospective Study to Review Patients at Risk for VTE at Hospital Discharge

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604370
First Posted: January 30, 2008
Last Update Posted: February 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Samuel Z.Goldhaber, MD, Brigham and Women's Hospital
  Purpose
An investigator initiated study exploring VTE prophylaxis at the time of hospital discharge.

Condition
Venous Thromboembolism

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: VTE Prophylaxis Across the Continuum of Care: High Risk Patients at Hospital Discharge

Resource links provided by NLM:


Further study details as provided by Samuel Z.Goldhaber, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Symptomatic PE/DVT within 90 days of hospital discharge. [ Time Frame: 90 days ]

Enrollment: 2500
Study Start Date: February 2008
Study Completion Date: December 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Acutely ill medical and surgical patients who were hospitalized at BWH, and at-risk for VTE, but were not treated with prophylaxis at hospital discharge.
2
Acutely ill medical and surgical patients who were at risk for VTE at time of hospital discharge and prescribed a prophylaxis strategy.

Detailed Description:

It appears likely that many patients will remain at risk for VTE at the time of hospital discharge. These risks will go unrecognized, and discharge prophylaxis orders will not be prescribed.

To test this hypothesis, we will perform a retrospective review of approximately 2,500 patients at Brigham and Women's Hospital at risk for VTE at the time of hospital discharge to determine what proportion received VTE prophylaxis. We will correlate the implementation of discharge VTE prophylaxis with the occurrence of symptomatic DVT and pulmonary embolism within 90 days of hospital discharge.

We will also conduct a substudy of this patient population to determine adherence to VTE prophylaxis among hospitalized patients.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acutely ill medical and surgical patients who were hospitalized at BWH and who are at risk for DVT.
Criteria

Inclusion Criteria:

  • Acutely ill medical and surgical patients with a risk score of 4 or greater without prophylaxis or a risk score of 4 or greater with anticoagulation at hospital discharge.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604370


Sponsors and Collaborators
Brigham and Women's Hospital
Sanofi
Investigators
Principal Investigator: Samuel Z Goldhaber, MD Brigham and Women's Hospital
  More Information

Responsible Party: Samuel Z.Goldhaber, MD, Director, VTE Research Group, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00604370     History of Changes
Other Study ID Numbers: 2006-P-001981
First Submitted: December 28, 2007
First Posted: January 30, 2008
Last Update Posted: February 10, 2012
Last Verified: February 2012

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