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

Completed

• Conditions: Cardiovascular Disease
• Interventions: Drug: Fondaparinux Sodium

• Registration Number: NCT01390883
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients prescribed fondaparinux	Fondaparinux Sodium	Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments prescribed fondaparinux during study period

Primary Outcome Measures

Name	Time	Method
Presence or absence of venous thromboembolism after treatment of fondaparinux	4 months at maximum
The number of adverse events in Japanese patients treated with fondaparinux	4 months at maximum