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Trial registered on ANZCTR


Registration number
ACTRN12610000734066
Ethics application status
Not yet submitted
Date submitted
26/08/2010
Date registered
3/09/2010
Date last updated
3/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Arterial line versus venous line administration of Low Molecular Weight Heparin, Enoxaparin for prevention of thrombosis in the extracorporeal blood circuit of patients on Haemodialysis or Haemodiafiltration through arterio-venous access and using high-flux membrane– A randomised cross-over trial.
Scientific title
Effect of venous line administration of Low Molecular Weight Heparin, Enoxaparin compared to manufacturer recommended arterial line administration on four hour post injection anti-Xa level in patients on Haemodialysis or Haemodiafiltration through arterio-venous access and using high-flux membrane – A randomised cross-over trial.
Secondary ID [1] 252551 0
Nil
Universal Trial Number (UTN)
U1111-1116-7289
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease patient on Haemodialysis or Haemodiafiltration. 258034 0
Condition category
Condition code
Renal and Urogenital 258200 258200 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental - administration of Low Molecular Weight Heparin, Enoxaparin in to the venous line of extracorporeal blood circuit in patients on Haemodialysis or Haemodiafiltration through Arterio-Venous access and using high-flux membrane.

Enoxaparin dose will vary for each patient based on their weight. The starting dose is 0.5mg/kg and the dose will be constant throughout the trial period.
Enoxaparin will be administered as a bolus injection either through the arterial or venous line.
Overall duration of the intervention - 28 days.
In this trial patients will cross over from the arterial administration to venous administration, and vice versa, with a "wash-out" period of 2 weeks in between the switch..
Intervention code [1] 257075 0
Treatment: Drugs
Comparator / control treatment
Control - administration of Low Molecular Weight Heparin, Enoxaparin in to the arterial line of extracorporeal blood circuit (as per the manufacturer’s recommendation) in patients on Haemodialysis or Haemodiafiltration through Arterio-Venous access and using high-flux membrane.

Enoxaparin dose will vary for each patient based on their weight. The starting dose is 0.5mg/kg and the dose will be constant throughout the trial period.
Enoxaparin will be administered as a bolus injection either through the arterial or venous line.
Overall duration of the intervention - 28 days.
Control group
Active

Outcomes
Primary outcome [1] 259058 0
Anti-Xa level four hour post administration of equal dose of enoxaparin.

Plasma Anti-Xa level will be compared between both groups for the same dose of enoxaparin. We are expecting higher Anti-Xa level when enoxaparin is administered via the venous route.
Timepoint [1] 259058 0
At run in phase (week 1), beginning of week 2, end of week 3 and end of week 5.
Secondary outcome [1] 265324 0
Anti-Xa level .

Plasma Anti-Xa level will be compared between both groups for the same dose of enoxaparin. This secondary outcome Anti-Xa measurement is done for safety purpose at baseline and immediately after cross-over.
Timepoint [1] 265324 0
Time 0, level before administration of enoxaparin, at week 1, 3 and 5.
Secondary outcome [2] 265374 0
Manual compression time.

Manual compression time after removal of the dialysis needle would be measured in minutes/seconds using a stop clock.
Timepoint [2] 265374 0
Every dialysis session from week 1 to 7.

3 per week.
Secondary outcome [3] 265375 0
Visual inspection of the extracorporeal circuit
Timepoint [3] 265375 0
Every dialysis session from week 1 to 7.

3 per week.
Secondary outcome [4] 265376 0
Major, life-threatening and minor bleeding.

Major bleeding - reduction in the hemoglobin level of at least 20 g per liter, transfusion of at least 2 units of blood, or symptomatic bleeding in a critical area or organ.

Life-threatening bleeding - fatal bleeding, symptomatic intracranial bleeding, bleeding with a decrease in the hemoglobin level of at least 50 g per liter, or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery.

Minor - All other bleeding.

These secondary outcome would be assessed by clinical assessment and blood test (haemoglobin measurement)
Timepoint [4] 265376 0
Throughout the trial period from week 1 to 7.

Eligibility
Key inclusion criteria
1. 18 years of age or above
2. End stage renal disease on maintenance Haemodialysis/Haemodiafiltration, 3 times a week for 4 hours (3-5 hours).
3. On Haemodialysis/Haemodiafiltration for greater than or equal to 3 months
4. No change in Enoxaparin dosage for greater than or equal to 3 months
5. Stable target weight for greater than or equal to 3 months (2% change permitted).
6. Haemodialysis access - arteriovenous access
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to provide consent.
2. Heparin induced thrombocytopenia.
3. On other anticoagulants like Warfain.
4. On Clopidogrel or Dipyridamole.
5. Hypersensitivity to enoxaparin.
6. Dialysis through central venous catheter.
7. Vascular access thrombosis within 3 months of study start.
8. Pre-existing coagulation abnormalities (e.g. prolonged Activated Partial Thromboplastin Time (APTT))
9. Baseline thrombocytopenia <140.
10. Drugs that could affect heparin activity (e.g. tetracyclines, digitalis, and antihistamines)
11. Pregnancy
12. Active malignancy
13. Morbid obesity (Body Mass Index (BMI)>40)
14. History of circuit clotting or prolonged bleeding from the vascular access site over the last three months
15. Access flows on Arterio-Venous Fistula (AVF) of <500 mls/min
16. Single needle dialysis

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)
A random list of all eligible patients will be generated. The patients on the list will be approached in order by the Principle or Associate investigators, for participation in the study, until the required number of patients are recruited.

Telephone randomisation of consenting patients by the hospital pharmacist who is not an investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation.
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/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3155 0
4215
Recruitment postcode(s) [2] 3156 0
4226

Funding & Sponsors
Funding source category [1] 257547 0
Hospital
Name [1] 257547 0
Gold Coast hospital
Address [1] 257547 0
108 Nerang Street
Southport
QLD 4215
Country [1] 257547 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital
Address
108 Nerang Street
Southport
QLD 4215
Country
Australia
Secondary sponsor category [1] 256768 0
None
Name [1] 256768 0
Address [1] 256768 0
Country [1] 256768 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259547 0
Gold Coast Health Service District Human Research Ethics Committee
Ethics committee address [1] 259547 0
108 Nerang Street
Southport
QLD 4215
Ethics committee country [1] 259547 0
Australia
Date submitted for ethics approval [1] 259547 0
10/09/2010
Approval date [1] 259547 0
Ethics approval number [1] 259547 0

Summary
Brief summary
Patient on Haemodialysis need Enoxaparin, a drug which is used to prevent blood clotting when the blood goes through the dialysis machine. The manufacturers recommendation is to give enoxaparin through the arterial route of the dialysis circuit. About 80% of enoxaparin gets eliminated by dialysis when administered through the arterial route of the circuit. Our hypothesis is that by administering enoxaparin via the venous route we will not lose the 80% of the drug and hence use less amount of enoxaparin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31561 0
Address 31561 0
Country 31561 0
Phone 31561 0
Fax 31561 0
Email 31561 0
Contact person for public queries
Name 14808 0
Bhadran Bose
Address 14808 0
Department of Nephrology
Gold Coast Hospital
108 Nerang Street
Southport
QLD 4215
Country 14808 0
Australia
Phone 14808 0
+61755198211
Fax 14808 0
Email 14808 0
bhadran_bose@health.qld.gov.au
Contact person for scientific queries
Name 5736 0
Bhadran Bose
Address 5736 0
Department of Nephrology
Gold Coast Hospital
108 Nerang Street
Southport
QLD 4215
Country 5736 0
Australia
Phone 5736 0
+61755198211
Fax 5736 0
Email 5736 0
bhadran_bose@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results