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

May 5, 2017 updated by: Baxter Healthcare Corporation

Pilot, Prospective, Multicenter, Open and Non-randomised Study: Definition of an Index of Anti Xa Value at the End of Hemodialysis Treatment.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Irigny, France, 69540
        • Calydial dialysis unit
      • Toulouse, France, 31400
        • Clinique St Exupery
      • Vandoeuvre Les Nancy, France
        • ALTIR Dialysis center
      • Vandoeuvre les Nancy, France, 54511
        • Hôpital Brabois
  • Germany
      • Hannover, Germany, 30625
        • Medizinische Hochschule
  • Italy
      • Verona, Italy
        • Borgo Trento Hospital
  • Sweden
      • Stockholm, Sweden
        • Karolinska Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary criterion is the measurement of Anti Xa at the end of dialysis sessions.
Time Frame: End of dialysis treatment
End of dialysis treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Collaborators

Gambro Lundia AB

Investigators

  • Study Chair: Michèle Kessler, Pf, Hopital Brabois, Vandoeuvre les Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 28, 2008

First Submitted That Met QC Criteria

October 28, 2008

First Posted (Estimate)

October 29, 2008

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1456
  • ISRCTN 93952087

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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