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

Primary Purpose

Chronic Kidney Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Evodial hemodialysers and Evodia blood lines
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Failure focused on measuring Chronic kidney failure, Heparin, Hemodialysis, Biocompatibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Calydial dialysis unit
  • Clinique St Exupéry
  • Hopital Brabois
  • ALTIR Dialysis center
  • Medizinische Hochschule
  • Borgo Trento Hospital
  • Karolinska Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Treatment with Evodial with reduction of heparin across study period

Outcomes

Primary Outcome Measures

The primary criterion is the measurement of Anti Xa at the end of dialysis sessions.

Secondary Outcome Measures

Follow-up of aPTT for patients treated with UFH,
Evaluation of TAT (Thrombin-Antithrombin) complex,
Follow-up of ionic clearance (Diascan) measurements during HD sessions,
Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale,
Follow-up of AE/SAE.

Full Information

First Posted
October 28, 2008
Last Updated
May 5, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Lundia AB
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1. Study Identification

Unique Protocol Identification Number
NCT00781690
Brief Title
Reduction of Heparin Dose in Dialysis With Evodial System
Acronym
RHODES
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 Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Lundia AB

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure
Keywords
Chronic kidney failure, Heparin, Hemodialysis, Biocompatibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Treatment with Evodial with reduction of heparin across study period
Intervention Type
Device
Intervention Name(s)
Evodial hemodialysers and Evodia blood lines
Intervention Description
Maximum 8 weeks treatment with Evodial dialysers with reduction of heparin dose
Primary Outcome Measure Information:
Title
The primary criterion is the measurement of Anti Xa at the end of dialysis sessions.
Time Frame
End of dialysis treatment
Secondary Outcome Measure Information:
Title
Follow-up of aPTT for patients treated with UFH,
Time Frame
Kinetic on single dialysis treatment
Title
Evaluation of TAT (Thrombin-Antithrombin) complex,
Time Frame
Kinetic on single dialysis treatment
Title
Follow-up of ionic clearance (Diascan) measurements during HD sessions,
Time Frame
Kinetic of single dialysis treatment
Title
Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale,
Time Frame
End of dialysis treatment
Title
Follow-up of AE/SAE.
Time Frame
All treatments during study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michèle Kessler, Pf
Organizational Affiliation
Hopital Brabois, Vandoeuvre les Nancy
Official's Role
Study Chair
Facility Information:
Facility Name
Calydial dialysis unit
City
Irigny
ZIP/Postal Code
69540
Country
France
Facility Name
Clinique St Exupéry
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Hopital Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
ALTIR Dialysis center
City
Vandoeuvre Les Nancy
Country
France
Facility Name
Medizinische Hochschule
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Borgo Trento Hospital
City
Verona
Country
Italy
Facility Name
Karolinska Hospital
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
13679486
Citation
Lavaud S, Canivet E, Wuillai A, Maheut H, Randoux C, Bonnet JM, Renaux JL, Chanard J. Optimal anticoagulation strategy in haemodialysis with heparin-coated polyacrylonitrile membrane. Nephrol Dial Transplant. 2003 Oct;18(10):2097-104. doi: 10.1093/ndt/gfg272.
Results Reference
background
PubMed Identifier
18156457
Citation
Chanard J, Lavaud S, Maheut H, Kazes I, Vitry F, Rieu P. The clinical evaluation of low-dose heparin in haemodialysis: a prospective study using the heparin-coated AN69 ST membrane. Nephrol Dial Transplant. 2008 Jun;23(6):2003-9. doi: 10.1093/ndt/gfm888. Epub 2007 Dec 21.
Results Reference
background
PubMed Identifier
22925178
Citation
Kessler M, Gangemi C, Gutierrez Martones A, Lacombe JL, Krier-Coudert MJ, Galland R, Kielstein JT, Moureau F, Loughraieb N. Heparin-grafted dialysis membrane allows minimal systemic anticoagulation in regular hemodialysis patients: a prospective proof-of-concept study. Hemodial Int. 2013 Apr;17(2):282-93. doi: 10.1111/j.1542-4758.2012.00733.x. Epub 2012 Aug 23.
Results Reference
derived

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Reduction of Heparin Dose in Dialysis With Evodial System

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