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

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.

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 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

Treatment and study plan

Fondaparinux sodium

Drug

Primary outcomes

The number of adverse events in Japanese subjects undergoing general surgery of the lower limb treated with fondaparinux

Time frame: 1 month
Presence of absence of venous thromboembolism after treatment of fondaparinux

Time frame: 1 month
Occurrence of adverse events of bleeding

Time frame: 1 month

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Jul 11, 2011
Registry last updated: Jul 28, 2014

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