Overview

This trial is active, not recruiting.

Condition cardiovascular disease
Treatment fondaparinux sodium
Sponsor GlaxoSmithKline
Start date September 2009
End date June 2012
Trial size 329 participants
Trial identifier NCT01390896, 112797

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism
fondaparinux sodium

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.