Fondaparinux as an Anticoagulant in Haemofiltration in Pa... | NCT00256100

Studies
Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure.

NCT00256100

Sponsor

Melbourne Health

Status

Terminated

Last Update Posted

Apr 12, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Renal Failure

Interventions

Fondaparinux Sodium

Countries

Australia

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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Teh Priincipal investigator responsible for the trial no longer employed at the study site.

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Nov 17, 2005

First Submission Date that Met QC Criteria

Nov 17, 2005

First Posted Date

Nov 21, 2005Estimated

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

Apr 10, 2017

Last Update Posted Date

Apr 12, 2017Actual

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 project is to assess the safety and effectiveness of fondaparinux, a new drug to prevent blood clotting in the continuous dialysis machine used in intensive care patients who have kidney failure.

Detailed Description

The study hypothesis is that when used as an anticoagulant in haemofiltration, fondaparinux prolongs the filter life when compared to enoxaparin.

Fondaparinux is the first compound of a new class of synthetic oligosaccharides with antithrombotic effects. It represents the active portion of the natural heparin molecule.

The null hypothesis is that there is no difference in filter life when using fondaparinux or enoxaparin as anticoagulation for haemofiltration.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
One	Active Comparator	Enoxaparin Sodium (Clexane ) is to be used in the control arm of the study	Drug: Fondaparinux Sodium
Two	Active Comparator	Fondaparinux will be used as the anticoagulant in the sencond arm of the study	Drug: Fondaparinux Sodium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fondaparinux Sodium	Drug	The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation	One Two

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The study will evaluate the duration of filter patency using fondaparinux as an anticoagulant in haemofiltration and compare this to the current standard haemofilter anticoagulant, enoxaparin.		Duration of the haemofilter life

Secondary Outcomes

Measure	Description	Time Frame
To assess the incidence of complications, primary bleeding with fondaparinux compared to enoxaparin in this setting.		Until hospital discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients (18 years or over) admitted to the ICU and expected to stay for more than 48 hours.
Patients who require continuous renal replacement therapy.
Patients who consent or if the patient is not competent, the next of kin who consent to inclusion in the study. .

-

Exclusion Criteria:

Patients aged less than 18 years of age.
Patients who are pregnant
Patients with a contraindication to anticoagulation for pre existing bleeding diathesis
Patients or next of kin who do not consent to study inclusion. -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John F Cade	Melbourne Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Royal Melbourne Hospital Intensive Care Unit Grattan Street		Parkville	Victoria	3050	Australia

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

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