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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Samuel Z.Goldhaber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00604370
First received: December 28, 2007
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Symptomatic PE/DVT within 90 days of hospital discharge. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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:

  • None.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604370

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

No publications provided

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
Study First Received: December 28, 2007
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013