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.

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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000734066

Enrollment

Registered

2010-09-03

Start date

2010-10-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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..

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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

Outcome results