HepZero:Heparin Free Dialysis With Evodial

March 11, 2025 updated by: Vantive Health LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
265

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Erasme Hospital
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • George Dumont Hospital
  • France
      • Lyon, France
        • Chu Edouard Herriot
      • Nancy, France
        • CHU Brabois
      • Saint-Priest en Jarez, France, 42270
        • CHU de Saint-Étienne - Hôpital Nord
  • Netherlands
      • Groningen, Netherlands
        • UMCG
  • Poland
      • Gdansk, Poland
        • Gdański Uniwersytet Medyczny
  • Spain
      • Badalona, Spain, 08916
        • Hospital Universitary German Trias i Pujol
      • Barcelona, Spain
        • Vall d'Hebron Hospital
  • United Kingdom
      • Liverpool, United Kingdom
        • Royal Liverpool University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Heparin free dialysis standard of care
Standard of care: can be either saline flushes or predilution (on-line or bags)
Other: Heparin free dialysis technique
Saline flushes or predilution
Other Names:
  • Standard of care
Experimental: Heparin free dialysis with Evodial
Device: Evodial
Evodial dialyer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
During first dialysis session_Dialysis duration: 4 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
2nd and 3rd consecutive dialysis sessions
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
During all dialysis sessions
Ease of use
Time Frame: During all dialysis sessions
Collection of saline flushes performed (volume and time)
During all dialysis sessions
Efficacy: Ultrafiltration
Time Frame: During all dialysis sessions
Measurement of urea, creatinine and ionogramm, UF achieved
During all dialysis sessions
Incidence of AEs/SAEs
Time Frame: During all dialysis sessions
Follow-up of AEs/SAEs
During all dialysis sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vantive Health LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baxter Healthcare Corporation
Gambro Lundia AB
Statistical Analysis : CIC CHU Brabois Nancy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Maurice Laville, Pr, CHU Edouard Herriot Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1483

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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