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Completed

NCT Number: NCT00333021

Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients

This study is phase 3 study for prevention of VTE in patients with abdominal surgery.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Hiroshima, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged >=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
  • General or urologic surgery
  • Cancer surgery
  • Gynecologic surgery
  • Radical surgery for pelvic malignancy

Exclusion criteria

  • Active, clinically significant bleeding Thrombocytopenia Body weight <40kg

Treatment and study plan

Fondaparinux sodium

Drug

GSK576428

Drug

Other names: Fondaparinux sodium

Primary outcomes

  1. Incidence of Venous thromboembolism and Major bleeding

    Time frame: Throughout entire study

Secondary outcomes

  1. Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism

    Time frame: Throughout entire study

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism (VTE) After Abdominal Surgery

Important dates

Study start
2006
Study completion
2007
First posted
Jun 2, 2006
Registry last updated
Jul 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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