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

Not Applicable

Completed

• Conditions: Adult Chronic Haemodialysis Patients Since at Least 3 Months
• Interventions: Other: heparin free haemodialysis

• Registration Number: NCT01221337
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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 %.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-14
• Study First Posted: 2010-10-15
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-10
• Last Update Posted: 2016-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
haemodialyzer EVODIAL-haemodialyzer VIE	heparin free haemodialysis	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.
haemodialyzer VIE-haemodialyzer Evodial	heparin free haemodialysis	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

CHU de Nice; 🇫🇷 Nice, France

Centre Hospitalier; 🇫🇷 Avignon, France