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HepZero:Heparin Free Dialysis With Evodial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01318486
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : April 5, 2017
Sponsor:
Collaborators:
Statistical Analysis : CIC CHU Brabois Nancy
Gambro Lundia AB
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Tracking Information
First Submitted Date  ICMJE March 11, 2011
First Posted Date  ICMJE March 18, 2011
Last Update Posted Date April 5, 2017
Study Start Date  ICMJE March 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
  • 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.
  • 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
  • Efficacy [ Time Frame: During all dialysis sessions ]
    Measurement of urea, creatinine and ionogramm, UF achieved
  • Ease of use [ Time Frame: During all dialysis sessions ]
    Collection of saline flushes performed (volume and time)
  • Safety [ Time Frame: During all dialysis sessions ]
    Follow-up of AEs/SAEs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HepZero:Heparin Free Dialysis With Evodial
Official Title  ICMJE HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease
  • Patients Requiring Heparin Free Dialysis Treatments
Intervention  ICMJE
  • Other: Heparin free dialysis technique
    Saline flushes or predilution
    Other Name: Standard of care
  • Device: Evodial
    Evodial dialyer
Study Arms  ICMJE
  • Active Comparator: Heparin free dialysis standard of care
    Standard of care: can be either saline flushes or predilution (on-line or bags)
    Intervention: Other: Heparin free dialysis technique
  • Experimental: Heparin free dialysis with Evodial
    Intervention: Device: Evodial
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2013)
266
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2011)
252
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Netherlands,   Poland,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01318486
Other Study ID Numbers  ICMJE 1483
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baxter Healthcare Corporation
Study Sponsor  ICMJE Baxter Healthcare Corporation
Collaborators  ICMJE
  • Statistical Analysis : CIC CHU Brabois Nancy
  • Gambro Lundia AB
Investigators  ICMJE
Study Chair: Maurice Laville, Pr CHU Edouard Herriot Lyon
PRS Account Baxter Healthcare Corporation
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP