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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01390883

Enrollment

475

Registered

2011-07-11

Start date

2008-12-31

Completion date

2013-10-31

Last updated

2015-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

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.

Interventions

DRUGFondaparinux Sodium

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026