NCT01390883CompletedNot Applicable
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 475
- Primary Endpoint
- Presence or absence of venous thromboembolism after treatment of fondaparinux
Study Overview
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients prescribed fondaparinux
Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments prescribed fondaparinux during study period
Intervention: Fondaparinux Sodium (Drug)
Outcomes
Primary Outcomes
Presence or absence of venous thromboembolism after treatment of fondaparinux
Time Frame: 4 months at maximum
The number of adverse events in Japanese patients treated with fondaparinux
Time Frame: 4 months at maximum
Secondary Outcomes
No secondary outcomes reported
Investigators
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