Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure.
Recruitment status was Recruiting
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.
Patients Requiring Haemofiltration for Acute Renal Failure.
Drug: Fondaparinux Sodium
|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.|
- 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 ]
- To assess the incidence of complications, primary bleeding with fondaparinux compared to enoxaparin in this setting. [ Time Frame: Until hospital discharge ]
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||December 2007|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256100
|Contact: Megan Robertson, MBBS||+ 61 3 email@example.com|
|Contact: Deborah Barge||+ 61 3 firstname.lastname@example.org|
|The Royal Melbourne Hospital Intensive Care Unit Grattan Street||Recruiting|
|Parkville, Victoria, Australia, 3050|
|Contact: Megan Robertson, MBBS +61 3 93427441 email@example.com|
|Contact: Deborah K Barge +61 3 93427441 firstname.lastname@example.org|
|Principal Investigator: John F Cade, MBBS|
|Sub-Investigator: Megan Robertson|
|Sub-Investigator: Julian Hunt-Smith|
|Principal Investigator:||John F Cade||Melbourne Health|