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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 %.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| haemodialyzer EVODIAL-haemodialyzer VIE | Other | 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 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heparin free haemodialysis | Other | Comparison of two haemodialyzers "VIE 2,1" versus "EVODIAL 2,2" in a strategy of heparin-free haemodialysis (HFH). |
|
| Measure | Description | 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
-- Adult chronic haemodialysis patients since al least 3 months
Non-inclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Shariful ISLAM, PH | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier | Avignon | 84902 | France | |||
| CHU de Nice |
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| 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 |
| Nice |
| 06000 |
| France |