Clinical trial NCT01318486: HepZero:Heparin Free Dialysis With Evodial
Official title: HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Patients Requiring Heparin Free Dialysis Treatments
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Statistical Analysis : CIC CHU Brabois Nancy
name: Gambro Lundia AB
name: Baxter Healthcare Corporation
First posted: 2011-03-18
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clotting of the dialysis session
timeFrame: During first dialysis session_Dialysis duration: 4 hours
Secondary outcomes:
measure: Clotting during consecutive dialysis session
timeFrame: 2nd and 3rd consecutive dialysis sessions
measure: Follow up of clotting during the dialysis sessions
timeFrame: During all dialysis sessions
measure: Efficacy: Ultrafiltration
timeFrame: During all dialysis sessions
measure: Ease of use
timeFrame: During all dialysis sessions
measure: Incidence of AEs/SAEs
timeFrame: During all dialysis sessions
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
city: Moncton
country: Canada
facility: George Dumont Hospital
state: New Brunswick
city: Lyon
country: France
facility: CHU Edouard Herriot
city: Nancy
country: France
facility: CHU Brabois
city: Saint-Priest en Jarez
country: France
facility: CHU de Saint-Étienne - Hôpital Nord
city: Groningen
country: Netherlands
facility: UMCG
city: Gdansk
country: Poland
facility: Gdanski Uniwersytet Medyczny
city: Badalona
country: Spain
facility: Hospital Universitary German Trias i Pujol
city: Barcelona
country: Spain
facility: Vall d'Hebron Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
Study officials:
affiliation: CHU Edouard Herriot Lyon
name: Maurice Laville, Pr
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.