NCT00333021

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

First QC Date

June 1, 2006

Last Update Submit

July 9, 2009

Conditions

Venous Thromboembolism

Keywords

Fondaparinux Abdominal surgery Japanese VTE

Outcome Measures

Primary Outcomes (1)

  • Incidence of Venous thromboembolism and Major bleeding

    Throughout entire study

Secondary Outcomes (1)

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

    Throughout entire study

Interventions

Fondaparinux sodiumDRUG
GSK576428DRUG
Also known as: Fondaparinux sodium

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

GSK Investigational Site

Hiroshima, 737-0811, Japan

Location

GSK Investigational Site

Hokkaido, 060-0061, Japan

Location

GSK Investigational Site

Hokkaido, 060-8543, Japan

Location

GSK Investigational Site

Hokkaido, 073-0164, Japan

Location

GSK Investigational Site

Hyōgo, 655-0004, Japan

Location

GSK Investigational Site

Ibaraki, 300-0053, Japan

Location

GSK Investigational Site

Kagawa, 760-0017, Japan

Location

GSK Investigational Site

Kagoshima, 890-0061, Japan

Location

GSK Investigational Site

Kagoshima, 892-8580, Japan

Location

GSK Investigational Site

Nara, 630-0227, Japan

Location

GSK Investigational Site

Osaka, 540-0006, Japan

Location

GSK Investigational Site

Osaka, 560-0055, Japan

Location

GSK Investigational Site

Osaka, 565-0871, Japan

Location

GSK Investigational Site

Osaka, 589-8511, Japan

Location

GSK Investigational Site

Osaka, 590-0132, Japan

Location

GSK Investigational Site

Osaka, 598-0048, Japan

Location

GSK Investigational Site

Saitama, 351-0102, Japan

Location

GSK Investigational Site

Tokyo, 152-0021, Japan

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

OligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 2, 2006

Study Start

May 1, 2006

Study Completion

February 1, 2007

Last Updated

July 10, 2009

Record last verified: 2009-07

Locations

JP(18)