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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of the Safety and Efficacy of Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Renal Failure.

Conditions
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Renal Failure

Intervention / Treatment
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* Drug: Fondaparinux Sodium


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One<br>Enoxaparin Sodium (Clexane ) is to be used in the control arm of the study | Drug: Fondaparinux Sodium<br>* The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation<br>* Other names: Arixtra;|
| Active Comparator: Two<br>Fondaparinux will be used as the anticoagulant in the sencond arm of the study | Drug: Fondaparinux Sodium<br>* The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation<br>* Other names: Arixtra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

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