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

Phase 3CompletedNCT00333021

GlaxoSmithKline127 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

127

Conditions

Venous Thromboembolism

Interventions

Fondaparinux sodiumDRUG

GSK576428DRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (18)

GSK Investigational Site

Hiroshima, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Outcomes

Primary Outcomes

Incidence of Venous thromboembolism and Major bleeding

Time frame: Throughout entire study

Secondary Outcomes

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

Time frame: Throughout entire study

Data from ClinicalTrials.gov

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