Heparin Free Haemodialysis With Haemodialyzers "VIE" Versus "EVODIAL"

Comparative Study of Two Haemodialyzers "VIE 2.1" Versus "EVODIAL2.2" in a Strategy of Heparin-free Haemodialysis (HFH)

The adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy during a haemodialysis session. In the cases of multiple coagulation defects having high haemorrhagic risk factors and the patients under anti-coagulation therapy, it is recommended to reduce the heparin doses or to do heparin free haemodialysis. Several strategies of low heparin or heparin free haemodialysis have been proposed till now, without a real success. The heparin coated polyacrylonitrile haemodialyser (EVODIAL) has been reported to have 90 % successful heparin-free haemodialysis sessions. On the other hand, the vitamin E coated polysulphone (VIE) has also been reported to have an anti oxidative and anti-thrombotic properties and a capacity to improve the haemorrheological factors of human blood, hence having a promising future to perform a successful haemodialysis session with less or without heparin. This randomised, multi-centric, cross-over and open study has been designed to compare non inferiority of the haemodialyzer VIE 2,1 versus EVODIAL2,2 with a risk alfa of 5% and an absolute accepted difference of 12 %.

Study Overview

• Status: Completed
• Conditions: Adult Chronic Haemodialysis Patients Since at Least 3 Months
• Intervention / Treatment: Other: heparin free haemodialysis

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84902
    • Centre Hospitalier
  • Nice, France, 06000
    • Chu de Nice

Participation Criteria

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:

-- Adult chronic haemodialysis patients since al least 3 months

• Two needles puncture of the fistula,
• Low molecular weight heparinization during haemodialysis sessions,
• Good fistula or central veinous catheter flow rate (blood pump flow rate ≥ 300 ml/min),
• Systolic blood pressure ≥ 110 mmHg (mean value of three last dialysis sessions.
• Patients capable to understand the design of the study and to follow the instructions
• Patients having the French social security system affiliation.

Non-inclusion criteria :

• C reactive protein > 30 mg/L.
• Single needle puncture of the fistula
• Active documented haemorrhage,
• Haemoglobin < 10 g/dl and/or need blood transfusion,
• Documented thrombophilia
• Patients waiting for renal graft
• Acute sepsis
• Fistula or catheter dysfunction
• Patients under anti-vitamine K
• Per dialytic hypotension requiring al least once a nurse intervention,
• Severe diseases (Dysglobulinemia, vascularitis, HIV…),
• Patients following another research protocol or have ended one less then one month before starting of this study.
• Pregnant or breast feeding patients,
• Minor patients or under law-protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: haemodialyzer EVODIAL-haemodialyzer VIE; Equal number of patients will start either with the haemodialyzer "VIE 2,1" or "EVODIAL 2,2" followed by a wash out period, before starting the other haemodialyzer.	Other: heparin free haemodialysis; Comparison of two haemodialyzers "VIE 2,1" versus "EVODIAL 2,2" in a strategy of heparin-free haemodialysis (HFH).
Other: haemodialyzer VIE-haemodialyzer Evodial; Equal number of patients will start either with the haemodialyzer "VIE 2,1" or "EVODIAL 2,2" followed by a wash out period, before starting the other haemodialyzer.	Other: heparin free haemodialysis; Comparison of two haemodialyzers "VIE 2,1" versus "EVODIAL 2,2" in a strategy of heparin-free haemodialysis (HFH).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of successful study periods with no circuit-clotting event leading to a premature interruption of any of the four dialysis sessions	during every haemodialysis sessions

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of dialysis session without blood circuit clotting	during every haemodialysis sessions
Number of times saline rinsing has been required	during every haemodialysis
Degree of blood clots in the venous bubble trap	during every haemodialysis sessions
Quality of blood restitution	during every haemodialysis sessions
Dialysis adequacy (KT/V)	during every haemodialysis sessions
Haematological status	during every haemodialysis sessions
tolerance	during every haemodialysis sessions

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Mohamed Shariful ISLAM, PH, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: October 14, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 15, 2010

Study Record Updates

• Last Update Posted (Estimate): June 13, 2016
• Last Update Submitted That Met QC Criteria: June 10, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: 10-PP-09