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

This study has been completed.

First Received on December 28, 2007. Last Updated on February 9, 2012 History of Changes

Sponsor:	Brigham and Women's Hospital
Collaborator:	Sanofi-Aventis
Information provided by (Responsible Party):	Samuel Z.Goldhaber, MD, 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

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

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-Aventis

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
Embolism and Thrombosis

Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on February 09, 2012