Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01390896
NCT01390896CompletedNot Applicable

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

GlaxoSmithKline0 sites329 target enrollmentStarted: September 2009Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
329
Primary Endpoint
The number of adverse events in Japanese subjects undergoing general surgery of the lower limb treated with fondaparinux
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Patients prescribed fondaparinux

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

Intervention: Fondaparinux Sodium (Drug)

Outcomes

Primary Outcomes

The number of adverse events in Japanese subjects undergoing general surgery of the lower limb treated with fondaparinux

Time Frame: 1 month

Occurrence of adverse events of bleeding

Time Frame: 1 month

Presence of absence of venous thromboembolism after treatment of fondaparinux

Time Frame: 1 month

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials

Completed
Not Applicable
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)Cardiovascular Disease
NCT01390883GlaxoSmithKline475
Withdrawn
Phase 2
A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)Coronary DiseaseMyocardial Infarction
NCT00060554Schering-Plough300
Terminated
Not Applicable
Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure.Renal Failure
NCT00256100Melbourne Health20
Completed
Phase 1
"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"Renal Insufficiency
NCT01121770Duke University9
Terminated
Phase 2
Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)Heparin-Induced Thrombocytopenia
NCT00673439University of Louisville3
Special Drug Use Investigation for ARIXTRA... | Clinical Trial