Heparin Free Haemodialysis With Haemodialyzers VIE Versus EVODIAL

Study Overview
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Brief Summary
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The adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy during a haemodialysis session. In the cases of multiple coagulation defects having high haemorrhagic risk factors and the patients under anti-coagulation therapy, it is recommended to reduce the heparin doses or to do heparin free haemodialysis. Several strategies of low heparin or heparin free haemodialysis have been proposed till now, without a real success. The heparin coated polyacrylonitrile haemodialyser (EVODIAL) has been reported to have 90 % successful heparin-free haemodialysis sessions. On the other hand, the vitamin E coated polysulphone (VIE) has also been reported to have an anti oxidative and anti-thrombotic properties and a capacity to improve the haemorrheological factors of human blood, hence having a promising future to perform a successful haemodialysis session with less or without heparin. This randomised, multi-centric, cross-over and open study has been designed to compare non inferiority of the haemodialyzer VIE 2,1 versus EVODIAL2,2 with a risk alfa of 5% and an absolute accepted difference of 12 %.

Official Title
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Comparative Study of Two Haemodialyzers VIE 2.1 Versus EVODIAL2.2 in a Strategy of Heparin-free Haemodialysis (HFH)

Conditions
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Adult Chronic Haemodialysis Patients Since at Least 3 Months

Intervention / Treatment
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* Other: heparin free haemodialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -- Adult chronic haemodialysis patients since al least 3 months Two needles puncture of the fistula, Low molecular weight heparinization during haemodialysis sessions, Good fistula or central veinous catheter flow rate (blood pump flow rate ≥ 300 ml/min), Systolic blood pressure ≥ 110 mmHg (mean value of three last dialysis sessions. Patients capable to understand the design of the study and to follow the instructions Patients having the French social security system affiliation. Non-inclusion criteria : C reactive protein > 30 mg/L. Single needle puncture of the fistula Active documented haemorrhage, Haemoglobin < 10 g/dl and/or need blood transfusion, Documented thrombophilia Patients waiting for renal graft Acute sepsis Fistula or catheter dysfunction Patients under anti-vitamine K Per dialytic hypotension requiring al least once a nurse intervention, Severe diseases (Dysglobulinemia, vascularitis, HIV…), Patients following another research protocol or have ended one less then one month before starting of this study. Pregnant or breast feeding patients, Minor patients or under law-protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: haemodialyzer EVODIAL-haemodialyzer VIE<br>Equal number of patients will start either with the haemodialyzer VIE 2,1 or EVODIAL 2,2 followed by a wash out period, before starting the other haemodialyzer. | Other: heparin free haemodialysis<br>* Comparison of two haemodialyzers VIE 2,1 versus EVODIAL 2,2 in a strategy of heparin-free haemodialysis (HFH).<br>|
| Other: haemodialyzer VIE-haemodialyzer Evodial<br>Equal number of patients will start either with the haemodialyzer VIE 2,1 or EVODIAL 2,2 followed by a wash out period, before starting the other haemodialyzer. | Other: heparin free haemodialysis<br>* Comparison of two haemodialyzers VIE 2,1 versus EVODIAL 2,2 in a strategy of heparin-free haemodialysis (HFH).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of successful study periods with no circuit-clotting event leading to a premature interruption of any of the four dialysis sessions |  | during every haemodialysis sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of dialysis session without blood circuit clotting |  | during every haemodialysis sessions | 
| Number of times saline rinsing has been required |  | during every haemodialysis | 
| Degree of blood clots in the venous bubble trap |  | during every haemodialysis sessions | 
| Quality of blood restitution |  | during every haemodialysis sessions | 
| Dialysis adequacy (KT/V) |  | during every haemodialysis sessions | 
| Haematological status |  | during every haemodialysis sessions | 
| tolerance |  | during every haemodialysis sessions |