Back to resultsFondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure.
Primary Purpose
Renal Failure
Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Fondaparinux Sodium
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure
Eligibility Criteria
Inclusion Criteria: Adult patients (18 years or over) admitted to the ICU and expected to stay for more than 48 hours. Patients who require continuous renal replacement therapy. Patients who consent or if the patient is not competent, the next of kin who consent to inclusion in the study. . - Exclusion Criteria: Patients aged less than 18 years of age. Patients who are pregnant Patients with a contraindication to anticoagulation for pre existing bleeding diathesis Patients or next of kin who do not consent to study inclusion. -
Sites / Locations
- The Royal Melbourne Hospital Intensive Care Unit Grattan Street
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
One
Two
Arm Description
Enoxaparin Sodium (Clexane ) is to be used in the control arm of the study
Fondaparinux will be used as the anticoagulant in the sencond arm of the study
Outcomes
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.
Secondary Outcome Measures
To assess the incidence of complications, primary bleeding with fondaparinux compared to enoxaparin in this setting.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00256100
Brief Title
Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure.
Official Title
Assessment of the Safety and Efficacy of Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Renal Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Teh Priincipal investigator responsible for the trial no longer employed at the study site.
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Melbourne Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One
Arm Type
Active Comparator
Arm Description
Enoxaparin Sodium (Clexane ) is to be used in the control arm of the study
Arm Title
Two
Arm Type
Active Comparator
Arm Description
Fondaparinux will be used as the anticoagulant in the sencond arm of the study
Intervention Type
Drug
Intervention Name(s)
Fondaparinux Sodium
Other Intervention Name(s)
Arixtra
Intervention Description
The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To assess the incidence of complications, primary bleeding with fondaparinux compared to enoxaparin in this setting.
Time Frame
Until hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (18 years or over) admitted to the ICU and expected to stay for more than 48 hours.
Patients who require continuous renal replacement therapy.
Patients who consent or if the patient is not competent, the next of kin who consent to inclusion in the study. .
-
Exclusion Criteria:
Patients aged less than 18 years of age.
Patients who are pregnant
Patients with a contraindication to anticoagulation for pre existing bleeding diathesis
Patients or next of kin who do not consent to study inclusion. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F Cade
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Melbourne Hospital Intensive Care Unit Grattan Street
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure.
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