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Trial registered on ANZCTR


Registration number
ACTRN12608000462381
Ethics application status
Approved
Date submitted
12/08/2008
Date registered
16/09/2008
Date last updated
7/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective randomised cross-over trial of regional citrate with heparin for anticoagulation and additional albumin prime in continuous venovenous haemofiltration in children
Scientific title
Paediatric Haemofiltration priming and anticoagulation methods - does additional heparinsed albumin priming, citrate or heparin anticoagulation produce the longest circuit lifetimes?
Secondary ID [1] 678 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute renal failure 3546 0
Condition category
Condition code
Renal and Urogenital 3702 3702 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The randomised cross over trial will aim to determine if additional priming of a haemofilter circuit with 5 u/ml heparinised 4% albumin increases circuit life (compared to only 5 u/ml heparinised saline). This additional priming will be performed before the circuit is connected to the patient.
The study will also determine if there is a difference between regional citrate and global heparinised anticoagulation on circuit life. The dose of citrate (in the form of ADC-A) will be titrated with a calcium chloride infusion to maintain circuit calcium’s of less than 0.3 mmol/L and a patient calcium of 1.0-1.3 mmol/L.
Upon recruitment all participants will be randomly assigned to one of 8 sequences of varying anticoagulation and priming methods as recommended for a four period crossover design with 2 factorial treatments. Their first 4 circuits will consist of two heparin and two citrate circuits, one of each will be primed with heparinised saline and the other with an additional heparinised albumin prime, with the order of the treatments determined by their pre-assigned randomised sequence.
As hemofiltration is necessary to maintain these patients there will be no intentional "wash out" period as with holding treatment may be detrimental to the patient.
Each circuit will run until TMP (Transmembrane Pressure) reaches 280mmHg, treatment needs to be interrupted for longer than two hours or a significant adverse event occured. The participant will be in the trial for a maximum of eight circuits.
Intervention code [1] 3258 0
Treatment: Other
Intervention code [2] 3326 0
Other interventions
Comparator / control treatment
Each participant is their own control
Control group
Active

Outcomes
Primary outcome [1] 4606 0
The primary outcome of the trial is haemofilter circuit duration, a TMP (Transmembrane Pressure) of 280mmHg determines end of circuit life. The data will be analysed using Kaplan-Meier plots, stratified log rank test and Cox proportional hazard regression of time to circuit failure, censoring circuits that are stopped for other reasons at the time of cessation.
Timepoint [1] 4606 0
A TMP (Transmembrane Pressure) of 280mmHg determines end of circuit life, circuits ceased for other reasons will be sensored
Secondary outcome [1] 7771 0
Secondary outcomes to be analysed will be adverse events, such as excessive bleeding (assessed by medical and nursing staff by the bedside), thrombocytopenia, metabolic acidosis and hypocalcaemia (assessed by regular blood tests) using x2 tests.
Timepoint [1] 7771 0
Adverse events will be assessed as they occur and at a quarterly review (depending on numbers) for the duration of the trial.

Eligibility
Key inclusion criteria
Any patient requiring Continuous Veno-venus Haemofiltration (CVVH) in the unit will be eligible for the trial. Parental consent will be obtained before the patient is recruited.
Minimum age
No limit
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with liver failure defined for the purpose of this trial as INR (international normalized ratio) >3 despite clotting factor replacement (these patients often have the problems of metabolizing heparin and citrate and more severe coagulopathy) or known sensitivity to heparin (i.e. heparin-induced thrombocytopenia) will be excluded from the trial. Patients with significant risk of bleeding (those with intra cranial, cerebral or pulmonary haemorrhage or stroke) will also be excluded, however, coagulopathic or thrombocytopenic patients without significant bleeding will be included.
If parental consent cannot be obtained or is not given the child will not participate in the trial.

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)
Upon recruitment all participants will be randomly assigned to one of 8 sequences of varying anticoagulation and priming methods as recommended for a four period crossover design with 2 factorial treatments.
Before the trial opaque randomisation envelopes will be created and drawn as each patient is recruited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence generation will use a simple randomisation using a randomisation table generated by a computer program.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 376 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 6156 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 3726 0
Hospital
Name [1] 3726 0
The Royal Childrens' Hospital Mebourne
Country [1] 3726 0
Australia
Primary sponsor type
Hospital
Name
The Royal Childrens' Hospital Mebourne
Address
Flemington Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 3344 0
None
Name [1] 3344 0
Address [1] 3344 0
Country [1] 3344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5779 0
The Royal Childrens' Hospital Mebourne
Ethics committee address [1] 5779 0
Ethics committee country [1] 5779 0
Australia
Date submitted for ethics approval [1] 5779 0
Approval date [1] 5779 0
18/07/2008
Ethics approval number [1] 5779 0
27108A

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

Contacts
Principal investigator
Name 28834 0
Rosemary McRae
Address 28834 0
50 Flemington Rd
Parkville 3052 VIC
Country 28834 0
Australia
Phone 28834 0
+61 3 9345 5218
Fax 28834 0
Email 28834 0
[email protected]
Contact person for public queries
Name 11991 0
Rosemary McRae
Address 11991 0
Flemington Rd, Parkville VIC 3052
Country 11991 0
Australia
Phone 11991 0
+613 9345 5218
Fax 11991 0
+613 9345 6840
Email 11991 0
[email protected]
Contact person for scientific queries
Name 2919 0
Rosemary McRae
Address 2919 0
Flemington Rd, Parkville VIC 3052
Country 2919 0
Australia
Phone 2919 0
+613 9345 5218
Fax 2919 0
+613 9345 6840
Email 2919 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
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Documents added automatically
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