HepZero:Heparin Free Dialysis With Evodial

• ClinicalTrials.gov Identifier: NCT01318486
• Recruitment Status: Completed
• First Posted: March 18, 2011
• Last Update Posted: April 5, 2017
• Sponsor: Baxter Healthcare Corporation
• Collaborators: Statistical Analysis : CIC CHU Brabois Nancy; Gambro Lundia AB
• Information provided by (Responsible Party): Baxter Healthcare Corporation

Tracking Information

• First Submitted Date: March 11, 2011
• First Posted Date: March 18, 2011
• Last Update Posted Date: April 5, 2017
• Study Start Date: March 2011
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 16, 2011)

Clotting of the dialysis session [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 16, 2011)

• Clotting during consecutive dialysis session [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During all dialysis sessions ]
  Measurement of urea, creatinine and ionogramm, UF achieved
• Ease of use [ Time Frame: During all dialysis sessions ]
  Collection of saline flushes performed (volume and time)
• Safety [ Time Frame: During all dialysis sessions ]
  Follow-up of AEs/SAEs

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Chronic Kidney Disease
• Patients Requiring Heparin Free Dialysis Treatments

Intervention

• Other: Heparin free dialysis technique
  Saline flushes or predilution
  Other Name: Standard of care
• Device: Evodial
  Evodial dialyer

Study Arms

• Active Comparator: Heparin free dialysis standard of care
  Standard of care: can be either saline flushes or predilution (on-line or bags)
  Intervention: Other: Heparin free dialysis technique
• Experimental: Heparin free dialysis with Evodial
  Intervention: Device: Evodial

Publications *

• Kim YG. Anticoagulation during haemodialysis in patients at high-risk of bleeding. Nephrology (Carlton). 2003 Oct;8 Suppl:S23-7. Review.
• 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.
• 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. Epub 2007 Dec 21.
• Lohr JW, Schwab SJ. Minimizing hemorrhagic complications in dialysis patients. J Am Soc Nephrol. 1991 Nov;2(5):961-75.
• 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, Dębska-Ślizień A, Fernández 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 22, 2013): 266
• Original Estimated Enrollment (submitted: March 16, 2011): 252
• Actual Study Completion Date: February 2013
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Canada, France, Netherlands, Poland, Spain, United Kingdom

Administrative Information

• NCT Number: NCT01318486
• Other Study ID Numbers: 1483
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Baxter Healthcare Corporation
• Study Sponsor: Baxter Healthcare Corporation

Collaborators

• Statistical Analysis : CIC CHU Brabois Nancy
• Gambro Lundia AB

Investigators

• Study Chair: Maurice Laville, Pr; CHU Edouard Herriot Lyon

• PRS Account: Baxter Healthcare Corporation
• Verification Date: April 2017