Chronic end-stage renal disease 'renal failure' - 'chronic end-stage renal disease'
Conditions
Interventions
Two types of therapies will be evaluated in parallel:
- Control Group: Heparin free hemodialysis treatment according to standard of
care.
- Study Group: Heparin free hemodialysis treatment with Evodi
Sponsors
Gambro Lundia AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients requiring heparin free dialysis treatments on nephrologists' prescription. 2. Chronic end-stage renal disease (ESRD) patients treated by maintenance hemodialysis for at least 3 months. 3. Patients with a well functioning blood access that can allow a blood flow of at least 250 ml/min. 4. Patients aged 18 years or more. 5. Written consent to participate in the study;Patients that have already been treated with heparin free hemodialysis can be included into the study: first treatment meaning first treatment evaluated when patient is enrolled in the study. Patients with a central venous catheter locked by heparin can be included in the study but a particular attention has to be paid to the sucking of heparin and the rinsing of catheter before starting the hemodialysis treatment.
Exclusion criteria
Exclusion criteria: 1. Patients in ICU (intensive care unit) setting. 2. AKI (acute kidney injury) patients. 3. Patients dialyzed in self care, satellite HD units. 4. Patients treated in single needle mode. 5. Known contraindication for heparin (HIT type II). 6. Patients requiring blood and other labile blood producs (i.e fresh frozen plasma, platelets, etc). 7. Patients receiving oral anticoagulants (including anti-vitamin K). 8. Patients receiving a combination (e.g. aspirin and clopidogrel) of anti-platelets agents 9. Patients treated with unfractionated or low molecular weight heparin beside the dialysis treatment to prevent deep vein thrombosis. 10. Pregnant/planning pregnancy and lactating women during the study period. 11. Adults patients protected by law. 12. Patients that are not affiliated to health insurance system. 13. Participation in other interventional studies during the study period. 14. Patients that have already been included in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of succes rates during the first heparin free dialysis treatment. 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 blood lines/ dialyzer because of clotting. - No premature stop /early rinse-back due to clotting. Evaluation of clotting in the air traps will be performed at each hour along the dialysis session by using a semi quantitative scale described below: - 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 The evaluation (clotting scoring) will be performed hourly by two independent observers. In any cases, including a potential dispute between the two observers, the decision to stop the dialysis session must be made only by authorized and trained members of the medical team i.e. the principal investigator or registered co-investigator. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of success rates during the second and the third consecutive heparin free dialysis treatment. 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 blood lines/ dialyzer because of clotting. - No premature stop /early rinse-back due to clotting. The evaluation (clotting scoring) will be performed hourly by two independent observers as for the first heparin free dialysis treatment described in section above regarding " Primary study parameters/outcome"). Efficacy assessment: - The UF achieved and weight loss, urea and creatinine reduction rates and also ionogram will be documented during all dialysis sessions. Ease of use: - To measure ease of use, frequency and remaining volume of saline flushes will be documented. Safety: - The occurrence of AEs/SAEs during the study will be collected. | — |
Countries
Netherlands
Outcome results
None listed