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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00256100
Registration number
NCT00256100
Ethics application status
Date submitted
17/11/2005
Date registered
21/11/2005
Date last updated
12/04/2017
Titles & IDs
Public title
Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure.
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Scientific title
Assessment of the Safety and Efficacy of Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Renal Failure.
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Secondary ID [1]
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2004.066
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Renal Failure
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fondaparinux Sodium
Active Comparator: One - Enoxaparin Sodium (Clexane ) is to be used in the control arm of the study
Active Comparator: Two - Fondaparinux will be used as the anticoagulant in the sencond arm of the study
Treatment: Drugs: Fondaparinux Sodium
The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Duration of the haemofilter life
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Secondary outcome [1]
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To assess the incidence of complications, primary bleeding with fondaparinux compared to enoxaparin in this setting.
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Assessment method [1]
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Timepoint [1]
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Until hospital discharge
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Eligibility
Key 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. .
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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. -
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2007
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Royal Melbourne Hospital Intensive Care Unit Grattan Street - Parkville
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Recruitment postcode(s) [1]
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3050 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
Melbourne Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00256100
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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John F Cade
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Address
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Melbourne Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00256100
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