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

NCT ID: NCT01390896

Last Updated: 2014-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

329 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Patients prescribed fondaparinux

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

Fondaparinux Sodium

Intervention Type DRUG

Interventions

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Fondaparinux Sodium

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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112797

Identifier Type: -

Identifier Source: org_study_id

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