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

Completed

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

• Registration Number: NCT01390896
• 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 general surgery of the lower limb at high risk of developing venous thromboembolism.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-24
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients prescribed fondaparinux	Fondaparinux Sodium	Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism

Primary Outcome Measures

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