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

Melbourne Health

Status: Terminated

Conditions: Renal Failure

Treatments: Drug: Fondaparinux Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT00256100

2004.066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

One

Active Comparator group

Description:

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

Treatment:

Drug: Fondaparinux Sodium

Two

Active Comparator group

Description:

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

Treatment:

Drug: Fondaparinux Sodium