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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-12-31

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.

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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.

Conditions

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Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One

Enoxaparin Sodium (Clexane ) is to be used in the control arm of the study

Group Type ACTIVE_COMPARATOR

Fondaparinux Sodium

Intervention Type DRUG

The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation

Two

Fondaparinux will be used as the anticoagulant in the sencond arm of the study

Group Type ACTIVE_COMPARATOR

Fondaparinux Sodium

Intervention Type DRUG

The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation

Interventions

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Fondaparinux Sodium

The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation

Intervention Type DRUG

Other Intervention Names

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Arixtra

Eligibility Criteria

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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. -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No