NCT01390883

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
475

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

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

December 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

4.8 years

First QC Date

July 7, 2011

Last Update Submit

March 26, 2015

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

  • The number of adverse events in Japanese patients treated with fondaparinux

    4 months at maximum

  • Presence or absence of venous thromboembolism after treatment of fondaparinux

    4 months at maximum

Study Arms (1)

Patients prescribed fondaparinux

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

Drug: Fondaparinux Sodium

Interventions

Fondaparinux SodiumDRUG
Patients prescribed fondaparinux

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Japanese patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism

You may qualify if:

  • Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Fondaparinux

Intervention Hierarchy (Ancestors)

OligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

December 1, 2008

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

March 27, 2015

Record last verified: 2015-03