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

April 10, 2017 updated by: Melbourne Health

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital Intensive Care Unit Grattan Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: One
Enoxaparin Sodium (Clexane ) is to be used in the control arm of the study
Drug: Fondaparinux Sodium
The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation
Other Names:
  • Arixtra
ACTIVE_COMPARATOR: Two
Fondaparinux will be used as the anticoagulant in the sencond arm of the study
Drug: Fondaparinux Sodium
The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation
Other Names:
  • Arixtra

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Duration of the haemofilter life
Duration of the haemofilter life

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melbourne Health

Investigators

  • Principal Investigator: John F Cade, Melbourne Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

November 17, 2005

First Submitted That Met QC Criteria

November 17, 2005

First Posted (ESTIMATE)

November 21, 2005

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004.066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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