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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Drug: Fondaparinux Sodium

Study type: Observational

Funder types: Industry

Identifiers

NCT01390883

112721

Details and patient eligibility

About

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.

Enrollment: 475 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

475 participants in 1 patient group

Patients prescribed fondaparinux

Description:

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

Treatment:

Drug: Fondaparinux Sodium