Registry of Hospitalized Patients Treated With Fondaparinux

September 15, 2009 updated by: Brigham and Women's Hospital
Registry of Hospitalized patients at Brigham and Women's Hospital treated with Fondaparinux

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

220

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

BWH hospitalized patients receiving Fondaparinux

Description

Inclusion Criteria:

  • BWH hospitalized patients receiving Fondaparinux

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Venous Thromboembolism and Bleeding Events
Time Frame: 90 Days
90 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 30 Days
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Samuel Z Goldhaber, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (Estimate)

October 26, 2007

Study Record Updates

Last Update Posted (Estimate)

September 17, 2009

Last Update Submitted That Met QC Criteria

September 15, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-P-001294

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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