Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery

July 24, 2014 updated by: GlaxoSmithKline
The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing general surgery of the lower limb at high risk of developing venous thromboembolism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

329

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

Probability Sample

Study Population

Japanese patients undergoing general surgery of the lower limb at high risk for venous thromboembolism

Description

Inclusion Criteria:

  • Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism

Exclusion Criteria:

  • Patients with a history of hypersensitivity to the ingredients of fondaparinux
  • Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed)
  • Patients with acute bacterial endocarditis
  • Patients with severe renal impairment

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients prescribed fondaparinux
Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism
Drug: Fondaparinux Sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of adverse events in Japanese subjects undergoing general surgery of the lower limb treated with fondaparinux
Time Frame: 1 month
1 month
Presence of absence of venous thromboembolism after treatment of fondaparinux
Time Frame: 1 month
1 month
Occurrence of adverse events of bleeding
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

September 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 7, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

July 28, 2014

Last Update Submitted That Met QC Criteria

July 24, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112797

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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