RecruitingACTRN12619000416190

HepFree Trial: a Study to Compare Five Different Ways of Providing Heparin-free Hemodialysis in Patients With High Risk of Bleeding

Hemodialysis without Systemic Anticoagulation: A Prospective Randomized Trial to Evaluate Five Strategies in Patients at High Risk of Bleeding

Sponsor

Pedro Henrique Franca Gois

Enrollment

200 participants

Start Date

Oct 28, 2019

Study Type

Interventional

Conditions

High risk of bleeding Chronic Kidney Disease Hemodialysis Hemodiafiltration

Summary

Hemodialysis is life saving for patients with kidney failure. The contact of blood with an artificial environment may cause clots. Heparin is a substance that slows the formation of clots. However, this cannot be given to some patients who have high risk of bleeding. The aim of this research is to compare 5 different ways of providing heparin-free dialysis. These include intermittent saline flushes, artificial circuit coated with heparin, artificial circuit coated with heparin & intermittent saline flush, online predilution and predilution with coating of heparin. We aim to look at successful completion of dialysis without bleeding or clotting problems.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Haemodialysis is a life-sustaining treatment for people with kidney failure that filters the blood through a machine. A common challenge is preventing blood clots from forming in the dialysis circuit — normally managed with heparin, a blood-thinning medication. However, some patients are at high risk of bleeding and cannot safely receive heparin. For these patients, finding a safe and effective alternative is critical. This study compares five different strategies for heparin-free dialysis: saline flushes, heparin-coated circuits, a combination of both, a technique called online pre-dilution, and pre-dilution with a heparin-coated circuit. The goal is to identify which approach best completes the dialysis session without bleeding or clotting problems. You may be eligible if you have end-stage kidney failure, have been on regular dialysis for more than 3 months in a clinical setting, have been identified as at high risk of bleeding, and have suitable vascular access. People on dialysis in intensive care, those with acute kidney injury, known heparin allergy, current anticoagulation therapy, or liver problems would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Consecutive participants will be randomly allocated into five groups to receive different strategies of heparin-free dialysis treatment. There will be one control group and four "interventional" arms, as follows: Arm 1: Hemodialysis with heparin-coated dialyser/lines (EVODIAL dialyser and HEPRAN lines) Arm 2: Hemodialysis using a combination of heparin-coated dialyser/lines (EVODIAL dialyser and HEPRAN lines) and normal saline flushes (100 ml every 30 minutes throughout the whole treatment) Arm 3: Hemodiafiltration with predilution which is a modality of hemodialysis that uses dialyzers of high permeability and replaces the fluid losses before the blood enters the dialyser. Arm 4: Combination of hemodialfiltration with predilution and heparin-coated dialyser/lines (EVODIAL dialyser and HEPRAN lines) In arm 3 as well as in the control group, dialysers and lines will be used as per standard practices in Metro North Hospital and Health Services (i.e., Elisio 21H dialyser and non-heparin grafted lines). Participants will remain in the allocated group during a maximum of three consecutive heparin-free HD/HDF sessions, without any switch allowed between arms.