Special Drug Use Investigation for ARIXTRA (Fondaparinux)... | NCT01390896

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

NCT01390896

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Jul 28, 2014Estimated

Enrollment

329Actual

Phase

Not provided

Conditions

Cardiovascular Disease

Interventions

Fondaparinux Sodium

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Jul 7, 2011

First Submission Date that Met QC Criteria

Jul 7, 2011

First Posted Date

Jul 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2014

Last Update Posted Date

Jul 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

329Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients prescribed fondaparinux		Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism	Drug: Fondaparinux Sodium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fondaparinux Sodium	Drug		Patients prescribed fondaparinux

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077425	Fondaparinux

Ancestor Terms

ID	Term
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided