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NCT00549705 Clinical Trial

Registry of Hospitalized Patients Treated With Fondaparinux

Pulmonary Embolism Clinical Trial

Official title:
Registry of Hospitalized Patients Treated With Fondaparinux

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00549705
Other study ID # 2007-P-001294
Secondary ID
Status Completed
Phase N/A
First received October 24, 2007
Last updated September 15, 2009
Start date July 2007
Est. completion date June 2009

Study information
Verified date September 2009
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

Registry of Hospitalized patients at Brigham and Women's Hospital treated with Fondaparinux

Description:

The use of antithrombotic agents in the hospital is the mainstay of therapy for the treatment or prophylaxis of venous thromboembolism (VTE) and acute coronary syndrome (ACS). Concern with the administration of heparins and risk for adverse sequelae has led to the development of newer, longer-acting agents. Fondaparinux offers once daily administration with only an extremely small risk of developing heparin induced thrombocytopenia.

Recent data have further demonstrated the efficacy and safety of Fondaparinux in VTE and ACS, expanding its use in clinical practice. We aim to: 1) determine how Fondaparinux is being used in a "real life" clinical setting, a tertiary-care academic medical center (BWH), and 2) assess the associated clinical outcomes at 90 days after initiation of Fondaparinux.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- BWH hospitalized patients receiving Fondaparinux

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Brigham and Women's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Venous Thromboembolism and Bleeding Events 90 Days No
Secondary Mortality 30 Days No
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