NCT01420809

Brief Summary

This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism. (ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

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, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

July 28, 2011

Last Update Submit

May 15, 2017

Conditions

Thromboembolism

Outcome Measures

Primary Outcomes (3)

  • The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb

    3 months

  • Occurrence of adverse events of bleeding

    3 months

  • Presence or absence of venous thromboembolism after treatment of fondaparinux

    3 months

Eligibility Criteria

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

Subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism

You may qualify if:

  • Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 22, 2011

Study Start

September 1, 2007

Primary Completion

May 1, 2009

Study Completion

August 1, 2009

Last Updated

May 16, 2017

Record last verified: 2017-05