An interventional study of heparin free haemodialysis in Adult Chronic Haemodialysis Patients Since at Least 3 Months, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-13.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Prevention
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 %.
Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
-- Adult chronic haemodialysis patients since al least 3 months
Non-inclusion criteria :
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
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).
The percentage of successful study periods with no circuit-clotting event leading to a premature interruption of any of the four dialysis sessions
Time frame: during every haemodialysis sessions
Duration of dialysis session without blood circuit clotting
Time frame: during every haemodialysis sessions
Number of times saline rinsing has been required
Time frame: during every haemodialysis
Degree of blood clots in the venous bubble trap
Time frame: during every haemodialysis sessions
Quality of blood restitution
Time frame: during every haemodialysis sessions
Dialysis adequacy (KT/V)
Time frame: during every haemodialysis sessions
Haematological status
Time frame: during every haemodialysis sessions
tolerance
Time frame: during every haemodialysis sessions
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice