HepZero:Heparin Free Dialysis With Evodial

This study has been completed.
Sponsor:
Collaborator:
Statistical Analysis : CIC CHU Brabois Nancy
Information provided by (Responsible Party):
Gambro Lundia AB
ClinicalTrials.gov Identifier:
NCT01318486
First received: March 11, 2011
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Patients Requiring Heparin Free Dialysis Treatments
Other: Heparin free dialysis technique
Device: Evodial
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups

Resource links provided by NLM:


Further study details as provided by Gambro Lundia AB:

Primary Outcome Measures:
  • Clotting of the dialysis session [ Time Frame: During first dialysis session_Dialysis duration: 4 hours ] [ Designated as safety issue: No ]

    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 [ Time Frame: 2nd and 3rd consecutive dialysis sessions ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    Measurement of urea, creatinine and ionogramm, UF achieved

  • Ease of use [ Time Frame: During all dialysis sessions ] [ Designated as safety issue: No ]
    Collection of saline flushes performed (volume and time)

  • Safety [ Time Frame: During all dialysis sessions ] [ Designated as safety issue: Yes ]
    Follow-up of AEs/SAEs


Enrollment: 266
Study Start Date: March 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Standard of care
Experimental: Heparin free dialysis with Evodial Device: Evodial
Evodial dialyer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318486

Locations
Belgium
Erasme Hospital
Brussels, Belgium
UZ Brussels
Brussels, Belgium
Canada, New Brunswick
George Dumont Hospital
Moncton, New Brunswick, Canada
France
CHU Edouard Herriot
Lyon, France
CHU Brabois
Nancy, France
CHU de Saint-Étienne - Hôpital Nord
Saint-Priest en Jarez, France, 42270
Netherlands
UMCG
Groningen, Netherlands
Poland
Gdanski Uniwersytet Medyczny
Gdansk, Poland
Spain
Hospital Universitary German Trias i Pujol
Badalona, Spain, 08916
Vall d'Hebron Hospital
Barcelona, Spain
United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
Sponsors and Collaborators
Gambro Lundia AB
Statistical Analysis : CIC CHU Brabois Nancy
Investigators
Study Chair: Maurice Laville, Pr CHU Edouard Herriot Lyon
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gambro Lundia AB
ClinicalTrials.gov Identifier: NCT01318486     History of Changes
Other Study ID Numbers: 1483
Study First Received: March 11, 2011
Last Updated: April 22, 2013
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014