Chronic renal failure Urological and Genital Diseases Chronic renal failure
Conditions
Interventions
There are three periods in this trial:
Period one: usual haemodialysis with usual heparin dose
Period two: participants will have a systematic decrease of heparin dosa
Sponsors
Gambro Lundia AB (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients suffering from chronic renal failure 2. Patients treated in haemodialysis (HD) three times a week for at least 3 months, with a stable heparin dose and the same filter 3. Patients treated in 4 - 4.5 hours HD mode with a blood flow between 300 - 350 ml/min 4. Patients for whom either low molecular weight heparin (LMWH) (enoxaparin, nadroparin, tinzaparin) or unfractionated heparin (UFH) is used 5. Patients with a well-functioning vascular access as judged by the investigator 6. Patients treated either on AK, Innova or Integra dialysis machines equipped with ionic dialysance device 7. Patients older than 18 years, either sex 8. Patients with negative serologies (acquired immune deficiency syndrome [AIDS], hepatitis) 9. Patients having signed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patient with heparin-induced thrombocytopenia (HIT) or known heparin allergy 2. Patient treated in HD in single needle mode 3. Patients with catheter 4. Patients with acute inflammatory event that may affect, as judged by investigator patients' safety or study results 5. Patients participating in other studies that could interfere with the objective of this study 6. Patients with active malignant disease 7. Patients receiving heparin outside dialysis treatment 8. Patients under guardianship 9. Pregnant women, nursing mothers and women planning a pregnancy during the course of this study 10. Patients with serious history of coagulopathy 11. Patients receiving Anti-Vitamin K medication 12. Patients receiving an association of anti-platelets agents 13. Patients with heparin dose that can not be reduced for technical reason (excluding patients receiving too low heparin dose with no possibility of further reduction)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the SIAX value according to the different study periods: 1.1. To compare the SIAX obtained with Evodial with the one obtained with usual haemodialyser 1.2. To compare SIAX obtained before and after the heparin dose decrease period 1.3. To compare the SIAX obtained after heparin dose decrease when using SMA blood lines in addition to Evodial haemodialyser 1.4. To compare the SIAX obtained before and after an additional heparin dose decrease period when using SMA blood lines in addition to Evodial haemodialyser 2. To assess the possibility to decrease heparin dose with Evodial 3. To assess the possibility of an additional heparin dose decrease when using SMA blood lines in addition to Evodial haemodialyser 4. To follow product's safety Exploratory objectives: 5. To assess low-thrombogenicity of Evodial when decreasing heparin 6. To verify that there is no evidence of product efficacy decrease when decreasing heparin 7. To assess Anti Xa and aPTT kinetics according to the level of heparin dose decrease 8. To assess the quality of the restitution according to the level of heparin dose decrease | — |
Primary
| Measure | Time frame |
|---|---|
| To collect data to define a statistical index of Anti Xa (SIAX) value, at the end of HD treatment, performed without any coagulation issues. | — |
Countries
France, Germany, Italy, Sweden
Outcome results
None listed