HepZero:Heparin Free Dialysis With Evodial

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Patients Requiring Heparin Free Dialysis Treatments
• Intervention / Treatment: Other: Heparin free dialysis technique; Device: Evodial

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Erasme Hospital
• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada
      • George Dumont Hospital
• France
  • Lyon, France
    • Chu Edouard Herriot
  • Nancy, France
    • CHU Brabois
  • Saint-Priest en Jarez, France, 42270
    • CHU de Saint-Etienne - Hopital Nord
• Netherlands
  • Groningen, Netherlands
    • UMCG
• Poland
  • Gdansk, Poland
    • Gdański Uniwersytet Medyczny
• Spain
  • Badalona, Spain, 08916
    • Hospital Universitary German Trias i Pujol
  • Barcelona, Spain
    • Vall d'Hebron Hospital
• United Kingdom
  • Liverpool, United Kingdom
    • Royal Liverpool University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Ease of use	Collection of saline flushes performed (volume and time)	During all dialysis sessions
Efficacy: Ultrafiltration	Measurement of urea, creatinine and ionogramm, UF achieved	During all dialysis sessions
Incidence of AEs/SAEs	Follow-up of AEs/SAEs	During all dialysis sessions

Collaborators and Investigators

• Sponsor: Vantive Health LLC
• Collaborators: Baxter Healthcare Corporation; Gambro Lundia AB; Statistical Analysis : CIC CHU Brabois Nancy
• Investigators: Study Chair: Maurice Laville, Pr, CHU Edouard Herriot Lyon

Publications and helpful links

General Publications

• Kim YG. Anticoagulation during haemodialysis in patients at high-risk of bleeding. Nephrology (Carlton). 2003 Oct;8 Suppl:S23-7. doi: 10.1046/j.1440-1797.8.s.3.x.
• European Best Practice Guidelines Expert Group on Hemodialysis, European Renal Association. Section V. Chronic intermittent haemodialysis and prevention of clotting in the extracorporal system. Nephrol Dial Transplant. 2002;17 Suppl 7:63-71. doi: 10.1093/ndt/17.suppl_7.63. No abstract available.
• Chanard J, Lavaud S, Maheut H, Kazes I, Vitry F, Rieu P. The clinical evaluation of low-dose heparin in haemodialysis: a prospective study using the heparin-coated AN69 ST membrane. Nephrol Dial Transplant. 2008 Jun;23(6):2003-9. doi: 10.1093/ndt/gfm888. Epub 2007 Dec 21.
• Lohr JW, Schwab SJ. Minimizing hemorrhagic complications in dialysis patients. J Am Soc Nephrol. 1991 Nov;2(5):961-75. doi: 10.1681/ASN.V25961.
• Yixiong Z, Jianping N, Yanchao L, Siyuan D. Low dose of argatroban saline flushes anticoagulation in hemodialysis patients with high risk of bleeding. Clin Appl Thromb Hemost. 2010 Aug;16(4):440-5. doi: 10.1177/1076029609334628. Epub 2009 Oct 14.
• Laville M, Dorval M, Fort Ros J, Fay R, Cridlig J, Nortier JL, Juillard L, Debska-Slizien A, Fernandez Lorente L, Thibaudin D, Franssen C, Schulz M, Moureau F, Loughraieb N, Rossignol P. Results of the HepZero study comparing heparin-grafted membrane and standard care show that heparin-grafted dialyzer is safe and easy to use for heparin-free dialysis. Kidney Int. 2014 Dec;86(6):1260-7. doi: 10.1038/ki.2014.225. Epub 2014 Jul 9.
• Rossignol P, Dorval M, Fay R, Ros JF, Loughraieb N, Moureau F, Laville M. Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial. Trials. 2013 Jun 1;14:163. doi: 10.1186/1745-6215-14-163.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: March 11, 2011
• First Submitted That Met QC Criteria: March 16, 2011
• First Posted (Estimated): March 18, 2011

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents; Anticoagulants; Heparin
• Other Study ID Numbers: 1483