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Completed

NCT Number: NCT01318486

HepZero:Heparin Free Dialysis With Evodial

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patients Requiring Heparin Free Dialysis Treatments Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heparin free dialysis technique

Other

Saline flushes or predilution

Other names: Standard of care

Evodial

Device

Evodial dialyer

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. Efficacy: Ultrafiltration

    Time frame: During all dialysis sessions

    Measurement of urea, creatinine and ionogramm, UF achieved

  4. Ease of use

    Time frame: During all dialysis sessions

    Collection of saline flushes performed (volume and time)

  5. Incidence of AEs/SAEs

    Time frame: During all dialysis sessions

    Follow-up of AEs/SAEs

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation
  • Gambro Lundia AB
  • Statistical Analysis : CIC CHU Brabois Nancy

Registry information

Official study title

HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 18, 2011
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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