临床试验/NCT01390883

NCT01390883已完成不适用

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

GlaxoSmithKline0 个研究点目标入组 475 人开始时间: 2008年12月最近更新: 2015年3月27日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 475
主要终点: Presence or absence of venous thromboembolism after treatment of fondaparinux

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments

排除标准

•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

研究组 & 干预措施

Patients prescribed fondaparinux

Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments prescribed fondaparinux during study period

干预措施: Fondaparinux Sodium (Drug)

结局指标

主要结局

Presence or absence of venous thromboembolism after treatment of fondaparinux

时间窗: 4 months at maximum

The number of adverse events in Japanese patients treated with fondaparinux

时间窗: 4 months at maximum

次要结局

未报告次要终点

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

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