HepZero:Heparin Free Dialysis With Evodial

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Patients Requiring Heparin Free Dialysis Treatments
• Interventions: Device: Evodial; Other: Heparin free dialysis technique

• Registration Number: NCT01318486
• Lead Sponsor: Vantive Health LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-18
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin free dialysis with Evodial	Evodial	-
Heparin free dialysis standard of care	Heparin free dialysis technique	Standard of care: can be either saline flushes or predilution (on-line or bags)

Primary Outcome Measures

Name	Time	Method
Clotting of the dialysis session	During first dialysis session_Dialysis duration: 4 hours	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

Secondary Outcome Measures

Name	Time	Method
Clotting during consecutive dialysis session	2nd and 3rd consecutive dialysis sessions	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.
Follow up of clotting during the dialysis sessions	During all 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
Efficacy: Ultrafiltration	During all dialysis sessions	Measurement of urea, creatinine and ionogramm, UF achieved
Ease of use	During all dialysis sessions	Collection of saline flushes performed (volume and time)
Incidence of AEs/SAEs	During all dialysis sessions	Follow-up of AEs/SAEs

Trial Locations

Locations (10)

Erasme Hospital; 🇧🇪 Brussels, Belgium

CHU Brabois; 🇫🇷 Nancy, France

George Dumont Hospital; 🇨🇦 Moncton, New Brunswick, Canada

CHU de Saint-Étienne - Hôpital Nord; 🇫🇷 Saint-Priest en Jarez, France

CHU Edouard Herriot; 🇫🇷 Lyon, France

Hospital Universitary German Trias i Pujol; 🇪🇸 Badalona, Spain

Gdanski Uniwersytet Medyczny; 🇵🇱 Gdansk, Poland

UMCG; 🇳🇱 Groningen, Netherlands

Vall d'Hebron Hospital; 🇪🇸 Barcelona, Spain

Royal Liverpool University Hospital; 🇬🇧 Liverpool, United Kingdom