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HepZero:Heparin Free Dialysis With Evodial

Primary Purpose

Chronic Kidney Disease, Patients Requiring Heparin Free Dialysis Treatments

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Heparin free dialysis technique
Evodial
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Erasme Hospital
  • George Dumont Hospital
  • CHU Edouard Herriot
  • CHU Brabois
  • CHU de Saint-Étienne - Hôpital Nord
  • UMCG
  • Gdanski Uniwersytet Medyczny
  • Hospital Universitary German Trias i Pujol
  • Vall d'Hebron Hospital
  • Royal Liverpool University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Heparin free dialysis standard of care

Heparin free dialysis with Evodial

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
Efficacy
Measurement of urea, creatinine and ionogramm, UF achieved
Ease of use
Collection of saline flushes performed (volume and time)
Safety
Follow-up of AEs/SAEs

Full Information

First Posted
March 11, 2011
Last Updated
January 7, 2022
Sponsor
Baxter Healthcare Corporation
Collaborators
Statistical Analysis : CIC CHU Brabois Nancy, Gambro Lundia AB
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1. Study Identification

Unique Protocol Identification Number
NCT01318486
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Statistical Analysis : CIC CHU Brabois Nancy, Gambro Lundia AB

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Patients Requiring Heparin Free Dialysis Treatments

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heparin free dialysis standard of care
Arm Type
Active Comparator
Arm Description
Standard of care: can be either saline flushes or predilution (on-line or bags)
Arm Title
Heparin free dialysis with Evodial
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Heparin free dialysis technique
Other Intervention Name(s)
Standard of care
Intervention Description
Saline flushes or predilution
Intervention Type
Device
Intervention Name(s)
Evodial
Intervention Description
Evodial dialyer
Primary Outcome Measure Information:
Title
Clotting of the dialysis session
Description
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
Time Frame
During first dialysis session_Dialysis duration: 4 hours
Secondary Outcome Measure Information:
Title
Clotting during consecutive dialysis session
Description
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.
Time Frame
2nd and 3rd consecutive dialysis sessions
Title
Follow up of clotting during the dialysis sessions
Description
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
Time Frame
During all dialysis sessions
Title
Efficacy
Description
Measurement of urea, creatinine and ionogramm, UF achieved
Time Frame
During all dialysis sessions
Title
Ease of use
Description
Collection of saline flushes performed (volume and time)
Time Frame
During all dialysis sessions
Title
Safety
Description
Follow-up of AEs/SAEs
Time Frame
During all dialysis sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Laville, Pr
Organizational Affiliation
CHU Edouard Herriot Lyon
Official's Role
Study Chair
Facility Information:
Facility Name
Erasme Hospital
City
Brussels
Country
Belgium
Facility Name
George Dumont Hospital
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
CHU Edouard Herriot
City
Lyon
Country
France
Facility Name
CHU Brabois
City
Nancy
Country
France
Facility Name
CHU de Saint-Étienne - Hôpital Nord
City
Saint-Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
UMCG
City
Groningen
Country
Netherlands
Facility Name
Gdanski Uniwersytet Medyczny
City
Gdansk
Country
Poland
Facility Name
Hospital Universitary German Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Vall d'Hebron Hospital
City
Barcelona
Country
Spain
Facility Name
Royal Liverpool University Hospital
City
Liverpool
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15012687
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.
Results Reference
background
PubMed Identifier
12386229
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.
Results Reference
background
PubMed Identifier
18156457
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.
Results Reference
background
PubMed Identifier
1760540
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.
Results Reference
background
PubMed Identifier
19833621
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.
Results Reference
background
PubMed Identifier
25007166
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.
Results Reference
derived
PubMed Identifier
23725299
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.
Results Reference
derived

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HepZero:Heparin Free Dialysis With Evodial

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