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

Venous Thromboembolism Clinical Trial

Official title:

VTE Prophylaxis Across the Continuum of Care: High Risk Patients at Hospital Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604370
• Other study ID #: 2006-P-001981
• Status: Completed
• Phase: N/A
• First received: December 28, 2007
• Last updated: February 9, 2012
• Start date: February 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: December 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic PE/DVT within 90 days of hospital discharge.		90 days	No