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

Not Applicable

Terminated

• Conditions: Renal Failure
• Interventions: Drug: Fondaparinux Sodium

• Registration Number: NCT00256100
• Lead Sponsor: Melbourne Health

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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-11-17
• Study First Submitted QC: 2005-11-17
• Study First Posted: 2005-11-21
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2015-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Adult patients (18 years or over) admitted to the ICU and expected to stay for more than 48 hours.

2. Patients who require continuous renal replacement therapy.

3. Patients who consent or if the patient is not competent, the next of kin who consent to inclusion in the study. .

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One	Fondaparinux Sodium	Enoxaparin Sodium (Clexane ) is to be used in the control arm of the study
Two	Fondaparinux Sodium	Fondaparinux will be used as the anticoagulant in the sencond arm of the study

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

The Royal Melbourne Hospital Intensive Care Unit Grattan Street; 🇦🇺 Parkville, Victoria, Australia