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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Drug: Fondaparinux Sodium

Study type: Observational

Funder types: Industry

Identifiers

NCT01390896

112797

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 general surgery of the lower limb at high risk of developing venous thromboembolism.

Enrollment: 329 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

329 participants in 1 patient group

Patients prescribed fondaparinux

Description:

Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism

Treatment:

Drug: Fondaparinux Sodium