Chronic Kidney Disease, Patients Requiring Heparin Free Dialysis Treatments
Conditions
Brief summary
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.
Interventions
OTHERHeparin free dialysis technique
Saline flushes or predilution
DEVICEEvodial
Evodial dialyer
Sponsors
Statistical Analysis : CIC CHU Brabois Nancy
Gambro Lundia AB
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients requiring heparin free dialysis treatments on nephrologists' prescription, * Chronic ESRD patients treated by maintenance hemodialysis for at least 3 months, * Patients with a well functioning blood access that can allow a blood flow of at least 250 ml/min, * Patients aged 18 years or more, * Written consent to participate in the study (informed consent).
Exclusion criteria
* Patients in ICU settings, * AKI patients, * Patients dialyzed in self care, satellite HD units, * Patients treated in single needle mode, * Known heparin contraindication (HIT type II), * Patients requiring blood and other labile blood products (i.e. fresh frozen plasma, platelets, etc …) transfusion during hemodialysis treatment, * Patients receiving oral anticoagulants (including Anti vitamin K), * Patients receiving a combination of anti-platelets agents, * Patients treated with unfractionated or low molecular weight heparin beside the dialysis treatment to prevent deep vein thrombosis, * Pregnant/ planning pregnancy and lactating women during study period, * Adult patients protected by the law, * Patients are not affiliated to health insurance system (beneficiary or dependant) * Participation in other interventional studies during the study period, * Patients that have already been included in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clotting of the dialysis session | During first dialysis session_Dialysis duration: 4 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clotting during consecutive dialysis session | 2nd and 3rd consecutive dialysis sessions | 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. |
| Follow up of clotting during the dialysis sessions | During all 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 |
| Efficacy: Ultrafiltration | During all dialysis sessions | Measurement of urea, creatinine and ionogramm, UF achieved |
| Ease of use | During all dialysis sessions | Collection of saline flushes performed (volume and time) |
| Incidence of AEs/SAEs | During all dialysis sessions | Follow-up of AEs/SAEs |
Countries
Belgium, Canada, France, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed