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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00256100

Enrollment

Registered

2005-11-21

Start date

2004-06-30

Completion date

2007-12-31

Last updated

2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure

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.

Interventions

DRUGFondaparinux Sodium

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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. -

Design outcomes

Primary

Measure	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

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026