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Registry of Hospitalized Patients Treated With Fondaparinux

This study has been completed.
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00549705
First received: October 24, 2007
Last updated: September 15, 2009
Last verified: September 2009
History of Changes
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Venous Thromboembolism and Bleeding Events [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
North American Thrombosis Forum (NATF)  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: October 24, 2007
Last Updated: September 15, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fondaparinux
 PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013