Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000401651
Ethics application status
Approved
Date submitted
10/09/2005
Date registered
14/09/2005
Date last updated
6/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of the safety and efficacy of fondaparinux as an anticoagulant in haemofiltraion in patients with acute renal failure
Scientific title
Assessment of the safety and efficacy of fondaparinux as an anticoagulant in haemofiltraion in patients with acute renal failure
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients requiring haemofiltration for acute renal failure. 507 0
Condition category
Condition code
Renal and Urogenital 585 585 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The active group will be given ondaparinux for anticoagulation for the first filter only during their course of haemofiltration.
The decision to commence or cease haemofiltraion will remain with treating physician.
Intervention code [1] 451 0
None
Comparator / control treatment
The control group will have enoxaparin for haemofilter anticoagulation which is the current practice in the Royal Melbourne Hispital Intensive Care Unit.
Control group
Active

Outcomes
Primary outcome [1] 679 0
The study will evaluate the duration of filter patency using fondaparinux as an anticoagulant in haemofiltration and compare this to current standard haemofilter anticoagulation with enoxaparin.
Timepoint [1] 679 0
Secondary outcome [1] 1391 0
To assess the incidence of complications, primarily bleeding, with fondaparinux compared to enoxaparin in this setting.
Timepoint [1] 1391 0

Eligibility
Key inclusion criteria
The study will be conducted in the Intensive Care Unit at The Royal Melbourne Hospital and will aim to include patients who fulfill the following criteria: 1.Adult patients admitted to the ICU with an expected stay of more than 48h. 2.Patients who require continuous renal replacement therapy. 3.Patients who consent or if the patient is incompetent, the next-of-kin who consent, to inclusion in the study.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients who are pregnant. 2.Patients with a contra-indication to anticoagulation for pre-existing bleeding diathesis. 3.Patients or next-to-kin who do not consent to study inclusion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentailly numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation matrix.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/06/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 639 0
Hospital
Name [1] 639 0
Intensive Care Research department Funding, Royal Melbourne Hospital
Country [1] 639 0
Australia
Primary sponsor type
Hospital
Name
Intensive Care Unit, RMH
Address
Country
Australia
Secondary sponsor category [1] 531 0
None
Name [1] 531 0
Nil
Address [1] 531 0
Country [1] 531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1771 0
Royal Melbourne Hospital
Ethics committee address [1] 1771 0
Ethics committee country [1] 1771 0
Australia
Date submitted for ethics approval [1] 1771 0
Approval date [1] 1771 0
Ethics approval number [1] 1771 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35914 0
Address 35914 0
Country 35914 0
Phone 35914 0
Fax 35914 0
Email 35914 0
Contact person for public queries
Name 9640 0
Dr M Robertson
Address 9640 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 9640 0
Australia
Phone 9640 0
+61 3 93427441
Fax 9640 0
+61 3 93428812
Email 9640 0
[email protected]
Contact person for scientific queries
Name 568 0
Belinda Howe
Address 568 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 568 0
Australia
Phone 568 0
+61 3 93427710
Fax 568 0
+61 3 93428812
Email 568 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.