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

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ClinicalTrials.gov Identifier: NCT00256100
Recruitment Status : Terminated (Teh Priincipal investigator responsible for the trial no longer employed at the study site.)
First Posted : November 21, 2005
Last Update Posted : April 12, 2017
Sponsor:
Information provided by:
Melbourne Health

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.

Condition or disease Intervention/treatment Phase
Renal Failure Drug: Fondaparinux Sodium Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

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 Name: 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 Name: Arixtra



Primary Outcome Measures :
  1. 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 :
  1. To assess the incidence of complications, primary bleeding with fondaparinux compared to enoxaparin in this setting. [ Time Frame: Until hospital discharge ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256100


Locations
Australia, Victoria
The Royal Melbourne Hospital Intensive Care Unit Grattan Street
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: John F Cade Melbourne Health

ClinicalTrials.gov Identifier: NCT00256100     History of Changes
Other Study ID Numbers: 2004.066
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2015

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Fondaparinux
PENTA
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents