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Registry of Hospitalized Patients Treated With Fondaparinux

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ClinicalTrials.gov Identifier: NCT00549705
Recruitment Status : Completed
First Posted : October 26, 2007
Last Update Posted : September 17, 2009
Sponsor:
Information provided by:
Brigham and Women's Hospital

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

Condition or disease
Deep Vein Thrombosis Pulmonary Embolism

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.


Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Registry of Hospitalized Patients Treated With Fondaparinux
Study Start Date : July 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 Days ]


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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

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

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 Posted: October 26, 2007    Key Record Dates
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