HepZero:Heparin Free Dialysis With Evodial

NCT01318486 | Completed DMC

• 1 other identifier: 1483
• Study Type: interventional
• Target: 265
• Locations: 7 countries
• Sites: 10

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.

Conditions

Chronic Kidney Disease; Patients Requiring Heparin Free Dialysis Treatments

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Clotting during consecutive dialysis session

  2nd and 3rd consecutive dialysis sessions

• Follow up of clotting during the dialysis sessions

  During all dialysis sessions

• Efficacy: Ultrafiltration

  During all dialysis sessions

• Ease of use

  During all dialysis sessions

• Incidence of AEs/SAEs

  During all dialysis sessions

Study Arms (2)

Heparin free dialysis standard of care

ACTIVE COMPARATOR

Standard of care: can be either saline flushes or predilution (on-line or bags)

Other: Heparin free dialysis technique

Heparin free dialysis with Evodial

EXPERIMENTAL

Device: Evodial

Interventions

Heparin free dialysis technique OTHER

Saline flushes or predilution

Also known as: Standard of care

Heparin free dialysis standard of care

Evodial DEVICE

Evodial dialyer

Heparin free dialysis with Evodial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vantive Health LLC: lead
• Statistical Analysis : CIC CHU Brabois Nancy: collaborator
• Gambro Lundia AB: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (10)

Erasme Hospital

Brussels, Belgium

Location

George Dumont Hospital

Moncton, New Brunswick, Canada

Location

CHU Edouard Herriot

Lyon, France

Location

CHU Brabois

Nancy, France

Location

CHU de Saint-Étienne - Hôpital Nord

Saint-Priest-en-Jarez, 42270, France

Location

UMCG

Groningen, Netherlands

Location

Gdanski Uniwersytet Medyczny

Gdansk, Poland

Location

Hospital Universitary German Trias i Pujol

Badalona, 08916, Spain

Location

Vall d'Hebron Hospital

Barcelona, Spain

Location

Royal Liverpool University Hospital

Liverpool, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 15012687 BACKGROUND

• 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.

  PMID: 12386229 BACKGROUND

• 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.

  PMID: 18156457 BACKGROUND

• 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.

  PMID: 1760540 BACKGROUND

• 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.

  PMID: 19833621 BACKGROUND

• Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

  PMID: 38189593 DERIVED

• 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.

  PMID: 25007166 DERIVED

• 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.

  PMID: 23725299 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Maurice Laville, Pr

  CHU Edouard Herriot Lyon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 18, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

CA (1); NL (1); FR (3); BE (1); PL (1); ES (2); GB (1)