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Reduction of Heparin Dose in Dialysis With Evodial System (RHODES)

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ClinicalTrials.gov Identifier: NCT00781690
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer. Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.

Condition or disease Intervention/treatment
Chronic Kidney Failure Device: Evodial hemodialysers and Evodia blood lines

Detailed Description:

In parallel to the new hemodialyzer, Evodia blood lines were developed to improve characteristics of the extracorporeal circuit in term of reduced activation of the coagulation system and lower deposits of clot components.

The aim is to provide a system (hemodialyzer and extracorporeal circuit) with a low thrombogenicity and that can be used with low heparin dose in order to reduce the patients' bleeding risk at the end of HD treatment.

Measurements of TAT (Thrombin-Antithrombin), the marker of the activation of the coagulation, will be performed during the study in order to evaluate the thrombogenicity of the system.

The ionic clearance will be collected during all treatments to evaluate the performance of the hemodialyzer.

The study will be divided into three steps

  • Period 1: Usual heparin dose with usual hemodialyzer and standard blood lines (baseline),
  • Period 2: Decrease of heparin dose with Evodial hemodialyzer and standard bloodlines
  • Period 3: Lowest heparin dose defined in step 2 using the system Evodial hemodialyzer and SMA bloodlines.

Each patient included into the study will perform the three steps. As the risk of extracorporeal circuit clotting will be rather important, no control group (usual hemodialyzer with heparin decrease dose) will be performed.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot, Prospective, Multicenter, Open and Non-randomised Study: Definition of an Index of Anti Xa Value at the End of Hemodialysis Treatment.
Study Start Date : September 2008
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Treatment with Evodial with reduction of heparin across study period
Device: Evodial hemodialysers and Evodia blood lines
Maximum 8 weeks treatment with Evodial dialysers with reduction of heparin dose


Outcome Measures

Primary Outcome Measures :
  1. The primary criterion is the measurement of Anti Xa at the end of dialysis sessions. [ Time Frame: End of dialysis treatment ]

Secondary Outcome Measures :
  1. Follow-up of aPTT for patients treated with UFH, [ Time Frame: Kinetic on single dialysis treatment ]
  2. Evaluation of TAT (Thrombin-Antithrombin) complex, [ Time Frame: Kinetic on single dialysis treatment ]
  3. Follow-up of ionic clearance (Diascan) measurements during HD sessions, [ Time Frame: Kinetic of single dialysis treatment ]
  4. Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale, [ Time Frame: End of dialysis treatment ]
  5. Follow-up of AE/SAE. [ Time Frame: All treatments during study period ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Patients suffering from chronic renal failure,
  • Patients treated in HD three times a week for at least 3 months, with a stable heparin dose and the same filter,
  • Patients treated in 4-4.5 hours HD mode with a blood flow between 300-350 ml/min,
  • Patients for whom either LMWH (Enoxaparin, Nadroparin, Tinzaparin) or UFH is used,
  • Patients with a well-functioning vascular access as judged by the investigator,
  • Patients treated either on AK, Innova or Integra dialysis machines equipped with ionic dialysance device,
  • Patients older than 18 years,
  • Patients with negative serologies (AIDS, Hepatitis)
  • Patients having signed consent to participate in the study.

Exclusion criteria

  • Patient with HIT or known heparin allergy,
  • Patient treated in HD in single needle mode,
  • Patients with catheter,
  • Patients with acute inflammatory event that may affect, as judged by investigator patients' safety or study results,
  • Patients participating in other studies that could interfere with the objective of this study,
  • Patients with active malignant disease,
  • Patients receiving heparin outside dialysis treatment,
  • Patients under guardianship,
  • Pregnant women, nursing mothers and women planning a pregnancy during the course of this study,
  • Patients with serious history of coagulopathy,
  • Patients receiving Anti-Vitamin K medication,
  • Patients receiving an association of anti platelets agents,
  • Patients with heparin dose that can not be reduced for technical reason (excluding patients receiving too low heparin dose with no possibility of further reduction).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781690


Locations
France
Calydial dialysis unit
Irigny, France, 69540
Clinique St Exupéry
Toulouse, France, 31400
Hopital Brabois
Vandoeuvre les Nancy, France, 54511
ALTIR Dialysis center
Vandoeuvre Les Nancy, France
Germany
Medizinische Hochschule
Hannover, Germany, 30625
Italy
Borgo Trento Hospital
Verona, Italy
Sweden
Karolinska Hospital
Stockholm, Sweden
Sponsors and Collaborators
Baxter Healthcare Corporation
Gambro Lundia AB
Investigators
Study Chair: Michèle Kessler, Pf Hopital Brabois, Vandoeuvre les Nancy
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00781690     History of Changes
Other Study ID Numbers: 1456
ISRCTN 93952087
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

Keywords provided by Baxter Healthcare Corporation:
Chronic kidney failure
Heparin
Hemodialysis
Biocompatibility

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action