Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)

The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments

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

Treatment and study plan

Fondaparinux sodium

Drug

Primary outcomes

The number of adverse events in Japanese patients treated with fondaparinux

Time frame: 4 months at maximum
Presence or absence of venous thromboembolism after treatment of fondaparinux

Time frame: 4 months at maximum

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Jul 11, 2011
Registry last updated: Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed