NCT01390896

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
329

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Typical duration 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

September 1, 2009

Completed
1.8 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
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

3.3 years

First QC Date

July 7, 2011

Last Update Submit

July 24, 2014

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (3)

  • The number of adverse events in Japanese subjects undergoing general surgery of the lower limb treated with fondaparinux

    1 month

  • Presence of absence of venous thromboembolism after treatment of fondaparinux

    1 month

  • Occurrence of adverse events of bleeding

    1 month

Study Arms (1)

Patients prescribed fondaparinux

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

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

You may qualify if:

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

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

September 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 28, 2014

Record last verified: 2014-07