Chronic Kidney DiseaseNCT01318486
HepZero:Heparin Free Dialysis With Evodial
A study testing Heparin free dialysis technique and Evodial in people with Chronic Kidney Disease and Patients Requiring Heparin Free Dialysis Treatments, run by Vantive Health LLC at 10 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Patients Requiring Heparin Free Dialysis Treatments
- What is being tested?
- Heparin free dialysis technique and Evodial
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 10 sitesin 7 countries
- Study dates
- Mar 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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,
Show all 14Show fewer
- 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.
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
France3 sites
CHU Edouard Herriot
Lyon
CHU Brabois
Nancy
CHU de Saint-Étienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270
Spain2 sites
Hospital Universitary German Trias i Pujol
Badalona, 08916
Vall d'Hebron Hospital
Barcelona
About this study
Official title: HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups
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.
- Being tested
- Heparin free dialysis technique, Evodial
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin free dialysis techniqueOther
Also called Standard of care
Saline flushes or predilution
EvodialDevice
Evodial dialyer
| Study group | Role | What they receive |
|---|---|---|
| Heparin free dialysis standard of care | Active comparator | Standard of care: can be either saline flushes or predilution (on-line or bags) Receives: Other: Heparin free dialysis technique |
| Heparin free dialysis with Evodial | Experimental | Not described Receives: Device: Evodial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During first dialysis session_Dialysis duration: 4 hours
Secondary outcomes (5)
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.
Measured: 2nd and 3rd consecutive dialysis sessions
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
Measured: During all dialysis sessions
Efficacy: Ultrafiltration
Measurement of urea, creatinine and ionogramm, UF achieved
Measured: During all dialysis sessions
Ease of use
Collection of saline flushes performed (volume and time)
Measured: During all dialysis sessions
Incidence of AEs/SAEs
Follow-up of AEs/SAEs
Measured: During all dialysis sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Statistical Analysis : CIC CHU Brabois Nancy, Gambro Lundia AB, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Maurice Laville, Pr, Study chair, CHU Edouard Herriot Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318486
- Sponsor's protocol ID
- 1483
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2011
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15012687European 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.
PubMed 12386229Chanard 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.
PubMed 18156457Lohr JW, Schwab SJ. Minimizing hemorrhagic complications in dialysis patients. J Am Soc Nephrol. 1991 Nov;2(5):961-75. doi: 10.1681/ASN.V25961.
PubMed 1760540Yixiong 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.
PubMed 19833621Natale 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.
PubMed 38189593Laville 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.
PubMed 25007166Rossignol 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.
PubMed 23725299
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups
- ClinicalTrials.gov ID
- NCT01318486
- Acronym / sponsor ID
- 1483
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Statistical Analysis : CIC CHU Brabois Nancy, Gambro Lundia AB, Baxter Healthcare Corporation
- Study start
- Mar 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin free dialysis standard of care | Active comparator | Other: Heparin free dialysis techniqueStandard of care: can be either saline flushes or predilution (on-line or bags) |
| Heparin free dialysis with Evodial | Experimental | Device: Evodial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (14 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin free dialysis techniqueAlso: Standard of careSaline flushes or predilution | Other | Heparin free dialysis standard of care |
| EvodialEvodial dialyer | Device | Heparin free dialysis with Evodial |
Primary outcome
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
5 secondary outcomes
Clotting during consecutive dialysis session
Time frame: 2nd and 3rd consecutive dialysis sessions
Follow up of clotting during the dialysis sessions
Time frame: During all dialysis sessions
Efficacy: Ultrafiltration
Time frame: During all dialysis sessions
Ease of use
Time frame: During all dialysis sessions
Incidence of AEs/SAEs
Time frame: During all dialysis sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Background: PubMed 15012687Kim 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.
- Background: PubMed 12386229European 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.
- Background: PubMed 18156457Chanard 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.
- Background: PubMed 1760540Lohr JW, Schwab SJ. Minimizing hemorrhagic complications in dialysis patients. J Am Soc Nephrol. 1991 Nov;2(5):961-75. doi: 10.1681/ASN.V25961.
- Background: PubMed 19833621Yixiong 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.
- Derived from this study: PubMed 38189593Natale 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.
- Derived from this study: PubMed 25007166Laville 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.
- Derived from this study: PubMed 23725299Rossignol 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Laville, Pr study chair
CHU Edouard Herriot Lyon
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin free dialysis technique and Evodial in people with Chronic Kidney Disease and Patients Requiring Heparin Free Dialysis Treatments, run by Vantive Health LLC at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Spain, Belgium, Canada, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clotting of the dialysis session (time frame: During first dialysis session_Dialysis duration: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01318486, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.