Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
265 participants
INTERVENTIONAL
2011-03-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Heparin free dialysis standard of care
Standard of care: can be either saline flushes or predilution (on-line or bags)
Heparin free dialysis technique
Saline flushes or predilution
Heparin free dialysis with Evodial
Evodial
Evodial dialyer
Interventions
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Heparin free dialysis technique
Saline flushes or predilution
Evodial
Evodial dialyer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Statistical Analysis : CIC CHU Brabois Nancy
UNKNOWN
Gambro Lundia AB
INDUSTRY
Baxter Healthcare Corporation
INDUSTRY
Vantive Health LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Maurice Laville, Pr
Role: STUDY_CHAIR
CHU Edouard Herriot Lyon
Locations
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Erasme Hospital
Brussels, , Belgium
George Dumont Hospital
Moncton, New Brunswick, Canada
CHU Edouard Herriot
Lyon, , France
CHU Brabois
Nancy, , France
CHU de Saint-Étienne - Hôpital Nord
Saint-Priest-en-Jarez, , France
UMCG
Groningen, , Netherlands
Gdanski Uniwersytet Medyczny
Gdansk, , Poland
Hospital Universitary German Trias i Pujol
Badalona, , Spain
Vall d'Hebron Hospital
Barcelona, , Spain
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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1483
Identifier Type: -
Identifier Source: org_study_id
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