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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Adult Chronic Haemodialysis Patients Since at Least 3 Months

Treatments: Other: heparin free haemodialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT01221337

10-PP-09

Details and patient eligibility

About

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 %.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

haemodialyzer EVODIAL-haemodialyzer VIE

Other group

Description:

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.

Treatment:

Other: heparin free haemodialysis

haemodialyzer VIE-haemodialyzer Evodial

Other group

Description:

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.

Treatment:

Other: heparin free haemodialysis