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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
History of Changes

March 11, 2011
April 22, 2013
March 2011
February 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01318486 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
HepZero:Heparin Free Dialysis With Evodial
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Patients Requiring Heparin Free Dialysis Treatments
  • Other: Heparin free dialysis technique
    Saline flushes or predilution
    Other Name: Standard of care
  • Device: Evodial
    Evodial dialyer
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
266
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Netherlands,   Poland,   Spain,   United Kingdom
 
NCT01318486
1483
Yes
Gambro Lundia AB
Gambro Lundia AB
Statistical Analysis : CIC CHU Brabois Nancy
Study Chair: Maurice Laville, Pr CHU Edouard Herriot Lyon
Gambro Lundia AB
April 2013

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