Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01390896

Enrollment

329

Registered

2011-07-11

Start date

2009-09-30

Completion date

2013-01-31

Last updated

2014-07-28

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 general surgery of the lower limb at high risk of developing venous thromboembolism.

Interventions

DRUGFondaparinux Sodium

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

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 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

Outcome results

None listed

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