HepZero:Heparin Free Dialysis With Evodial

Study Overview
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Brief Summary
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The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting.

Official Title
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HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups

Conditions
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Chronic Kidney Disease, Patients Requiring Heparin Free Dialysis Treatments

Intervention / Treatment
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* Other: Heparin free dialysis technique
* Device: Evodial


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring heparin free dialysis treatments on nephrologists' prescription, Chronic ESRD patients treated by maintenance hemodialysis for at least 3 months, Patients with a well functioning blood access that can allow a blood flow of at least 250 ml/min, Patients aged 18 years or more, Written consent to participate in the study (informed consent). Exclusion Criteria: Patients in ICU settings, AKI patients, Patients dialyzed in self care, satellite HD units, Patients treated in single needle mode, Known heparin contraindication (HIT type II), Patients requiring blood and other labile blood products (i.e. fresh frozen plasma, platelets, etc …) transfusion during hemodialysis treatment, Patients receiving oral anticoagulants (including Anti vitamin K), Patients receiving a combination of anti-platelets agents, Patients treated with unfractionated or low molecular weight heparin beside the dialysis treatment to prevent deep vein thrombosis, Pregnant/ planning pregnancy and lactating women during study period, Adult patients protected by the law, Patients are not affiliated to health insurance system (beneficiary or dependant) Participation in other interventional studies during the study period, Patients that have already been included in this study.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Heparin free dialysis standard of care<br>Standard of care: can be either saline flushes or predilution (on-line or bags) | Other: Heparin free dialysis technique<br>* Saline flushes or predilution<br>* Other names: Standard of care;|
| Experimental: Heparin free dialysis with Evodial<br> | Device: Evodial<br>* Evodial dialyer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clotting of the dialysis session | To evaluate the rate of successful treatments, clotting in the air traps will be evaluated using a scale grading from 1 to 4 and previously described in the literature. The first heparin free dialysis treatment will be considered successful when there is: No complete occlusion of air traps or dialyzer rendering dialysis impossible (grade 4 of the scale), No additional saline flushes to prevent clotting, No change of dialyzer or blood lines because of clotting No premature stop (early rinse-back) because of clotting | During first dialysis session_Dialysis duration: 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clotting during consecutive dialysis session | As for the first heparin free dialysis treatment, treatments will be considered successful when there is : No complete occlusion of air traps or dialyzer rendering dialysis impossible (grade 4 of the scale), No additional saline flushes to prevent clotting, No change of dialyzer or blood lines because of clotting No premature stop (early rinse-back) because of clotting. | 2nd and 3rd consecutive dialysis sessions | 
| Follow up of clotting during the dialysis sessions | Grade 1: No detectable clotting Grade 2: Minimal clot formation (Presence of fibrinous ring) Grade 3: Clot formation (up to 5 cm) but dialysis still possible Grade 4: complete occlusion of air traps or dialyzer rendering dialysis impossible | During all dialysis sessions | 
| Efficacy | Measurement of urea, creatinine and ionogramm, UF achieved | During all dialysis sessions | 
| Ease of use | Collection of saline flushes performed (volume and time) | During all dialysis sessions | 
| Safety | Follow-up of AEs/SAEs | During all dialysis sessions |