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

Inclusion Criteria5

Individuals with end stage renal failure on maintenance HD or HDF for more than 3 months;
In-centre dialysis; high risk of bleeding (at the discretion of the assisting renal physician);
Native or graft arteriovenous fistula with blood flow at least 250 ml/min;
Patients with a tunnelled catheter locked by heparin can be included in the study after removal of heparin and rinsing the catheter prior to starting the treatment;
Minimum age of 18 years with no gender restriction.

Exclusion Criteria12

Dialysis in the intensive care unit;
Patients with acute kidney injury;
Patients treated in single needle mode;
Known heparin contraindication (e.g. heparin-induced thrombocytopenia type II);
Patients requiring blood products;
Patients receiving oral anticoagulants (including anti-vitamin K) (> 3 days since treatment stopped and/or normalized international normalized ratio will be allowed);
Patients receiving a combination of anti-platelet agents (> 5 days since treatment stopping will be allowed);
Patients currently on unfractioned (UFH) or low molecular weight heparin (LMWH) for treatment of deep vein thrombosis;
Patients treated with UFH or LMWH to prevent deep vein thrombosis (24 hours since last dose of LMWH or 12 hours since last dose of UFH was allowed).
Patients with laboratory markers of liver dysfunction (ALT and AST more than double of upper borderline lab value);
Patients with known coagulopathy or haemostasis disorder (pathological value of prothrombin time and aPTT, and platelets less than 50,000/ul);
Patients with the diagnosis of malignancy.

Interested in this trial?

Get notified about updates and connect with the research team.

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.