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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Melbourne Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00256100
First received: November 17, 2005
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention
Patients Requiring Haemofiltration for Acute Renal Failure.
Drug: Fondaparinux Sodium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Safety and Efficacy of Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Renal Failure.

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 20
Study Start Date: June 2004
Estimated Study Completion Date: December 2007
Arms Assigned Interventions
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 Name: Arixtra

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256100

Contacts
Contact: Megan Robertson, MBBS + 61 3 93427441 megan.robertson@mh.org.au
Contact: Deborah Barge + 61 3 93427710 deborah.barge@mh.org.au

Locations
Australia, Victoria
The Royal Melbourne Hospital Intensive Care Unit Grattan Street Recruiting
Parkville, Victoria, Australia, 3050
Contact: Megan Robertson, MBBS    +61 3 93427441    megan.robertson@mh.org.au   
Contact: Deborah K Barge    +61 3 93427441    deborah.barge@mh.org.au   
Principal Investigator: John F Cade, MBBS         
Sub-Investigator: Megan Robertson         
Sub-Investigator: Julian Hunt-Smith         
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: John F Cade Melbourne Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00256100     History of Changes
Other Study ID Numbers: 2004.066
Study First Received: November 17, 2005
Last Updated: February 3, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Fondaparinux
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014