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Retrospective Study to Review Patients at Risk for VTE at Hospital Discharge
This study is enrolling participants by invitation only.
Sponsors and Collaborators: Brigham and Women's Hospital
Sanofi-Aventis
Information provided by: Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00604370
  Purpose

An investigator initiated study exploring VTE prophylaxis at the time of hospital discharge.


Condition
Venous Thromboembolism

U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Retrospective
Official Title: VTE Prophylaxis Across the Continuum of Care: High Risk Patients at Hospital Discharge

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 2500
Study Start Date: February 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2009 (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.

  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-Aventis
Investigators
Principal Investigator: Samuel Z Goldhaber, MD Brigham and Women's Hospital
  More Information

Responsible Party: Brigham and Women's Hospital ( Samuel Z. Goldhaber, MD )
Study ID Numbers: 2006-P-001981
Study First Received: December 28, 2007
Last Updated: January 29, 2008
ClinicalTrials.gov Identifier: NCT00604370  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Embolism and Thrombosis
Embolism
Vascular Diseases
Venous Thromboembolism
Thrombosis
Thromboembolism

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009