The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
265
Saline flushes or predilution
Evodial dialyer
Erasme Hospital
Brussels, Belgium
George Dumont Hospital
Moncton, New Brunswick, Canada
CHU Edouard Herriot
Lyon, France
CHU Brabois
Nancy, France
Clotting of the dialysis session
To evaluate the rate of successful treatments, clotting in the air traps will be evaluated using a scale grading from 1 to 4 and previously described in the literature. The first heparin free dialysis treatment will be considered successful when there is: * No complete occlusion of air traps or dialyzer rendering dialysis impossible (grade 4 of the scale), * No additional saline flushes to prevent clotting, * No change of dialyzer or blood lines because of clotting * No premature stop (early rinse-back) because of clotting
Time frame: During first dialysis session_Dialysis duration: 4 hours
Clotting during consecutive dialysis session
As for the first heparin free dialysis treatment, treatments will be considered successful when there is : * No complete occlusion of air traps or dialyzer rendering dialysis impossible (grade 4 of the scale), * No additional saline flushes to prevent clotting, * No change of dialyzer or blood lines because of clotting * No premature stop (early rinse-back) because of clotting.
Time frame: 2nd and 3rd consecutive dialysis sessions
Follow up of clotting during the dialysis sessions
* Grade 1: No detectable clotting * Grade 2: Minimal clot formation (Presence of fibrinous ring) * Grade 3: Clot formation (up to 5 cm) but dialysis still possible * Grade 4: complete occlusion of air traps or dialyzer rendering dialysis impossible
Time frame: During all dialysis sessions
Efficacy: Ultrafiltration
Measurement of urea, creatinine and ionogramm, UF achieved
Time frame: During all dialysis sessions
Ease of use
Collection of saline flushes performed (volume and time)
Time frame: During all dialysis sessions
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CHU de Saint-Étienne - Hôpital Nord
Saint-Priest-en-Jarez, France
UMCG
Groningen, Netherlands
Gdanski Uniwersytet Medyczny
Gdansk, Poland
Hospital Universitary German Trias i Pujol
Badalona, Spain
Vall d'Hebron Hospital
Barcelona, Spain
Royal Liverpool University Hospital
Liverpool, United Kingdom
Incidence of AEs/SAEs
Follow-up of AEs/SAEs
Time frame: During all dialysis sessions