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Registry of Hospitalized Patients Treated With Fondaparinux

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549705
First Posted: October 26, 2007
Last Update Posted: September 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Brigham and Women's Hospital
  Purpose
Registry of Hospitalized patients at Brigham and Women's Hospital treated with Fondaparinux

Condition
Deep Vein Thrombosis Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Registry of Hospitalized Patients Treated With Fondaparinux

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Venous Thromboembolism and Bleeding Events [ Time Frame: 90 Days ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 Days ]

Enrollment: 220
Study Start Date: July 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
BWH hospitalized patients receiving Fondaparinux
Criteria

Inclusion Criteria:

  • BWH hospitalized patients receiving Fondaparinux
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549705


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

Additional Information:
Responsible Party: Samuel Z. Goldhaber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00549705     History of Changes
Other Study ID Numbers: 2007-P-001294
First Submitted: October 24, 2007
First Posted: October 26, 2007
Last Update Posted: September 17, 2009
Last Verified: September 2009

Keywords provided by Brigham and Women's Hospital:
Anticoagulation
Thrombosis
Bleeding
Clotting
Pulmonary Embolism
Deep Vein Thrombosis

Additional relevant MeSH terms:
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fondaparinux
PENTA
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents