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CompletedNCT01390883Updated Mar 27, 2015

Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)

An observational study in Cardiovascular Disease, sponsored by GlaxoSmithKline. Completed. Per ClinicalTrials.gov, last updated 2015-03-27.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
475
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Disease
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 475 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Time perspective
Prospective
Enrollment
475 participants (actual)

Groups and cohorts

  • Patients prescribed fondaparinux

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

    Drug: Fondaparinux Sodium

Interventions

  • DrugFondaparinux Sodium
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What researchers measure

Primary outcomes

  1. The number of adverse events in Japanese patients treated with fondaparinux

    Time frame: 4 months at maximum

  2. Presence or absence of venous thromboembolism after treatment of fondaparinux

    Time frame: 4 months at maximum

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01390883
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 11, 2011
Start date
Dec 2008
Primary completion
Oct 2013
Completion
Oct 2013
Last update
Mar 27, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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