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

This study has been completed.
Sponsor:
Information provided by:
Gambro Lundia AB
ClinicalTrials.gov Identifier:
NCT00781690
First received: October 28, 2008
Last updated: February 15, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Chronic Kidney Failure
Device: Evodial hemodialysers and Evodia blood lines
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Gambro Lundia AB:

Primary Outcome Measures:
  • The primary criterion is the measurement of Anti Xa at the end of dialysis sessions. [ Time Frame: End of dialysis treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Follow-up of aPTT for patients treated with UFH, [ Time Frame: Kinetic on single dialysis treatment ] [ Designated as safety issue: No ]
  • Evaluation of TAT (Thrombin-Antithrombin) complex, [ Time Frame: Kinetic on single dialysis treatment ] [ Designated as safety issue: No ]
  • Follow-up of ionic clearance (Diascan) measurements during HD sessions, [ Time Frame: Kinetic of single dialysis treatment ] [ Designated as safety issue: No ]
  • Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale, [ Time Frame: End of dialysis treatment ] [ Designated as safety issue: No ]
  • Follow-up of AE/SAE. [ Time Frame: All treatments during study period ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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
Gambro Lundia AB
Investigators
Study Chair: Michèle Kessler, Pf Hopital Brabois, Vandoeuvre les Nancy
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nathalie Loughraïeb Study Manager, Gambro Lundia AB
ClinicalTrials.gov Identifier: NCT00781690     History of Changes
Other Study ID Numbers: 1456, ISRCTN 93952087
Study First Received: October 28, 2008
Last Updated: February 15, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Germany: Ethics Commission
Italy: Ethics Committee
Sweden: Regional Ethical Review Board

Keywords provided by Gambro Lundia AB:
Chronic kidney failure
Heparin
Hemodialysis
Biocompatibility

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

ClinicalTrials.gov processed this record on October 02, 2014