Chronic renal failure Urological and Genital Diseases Renal Failure
Conditions
Interventions
1. Investigational product: HEP-AN69ST
2. Control product: AN69AT
This is a non-randomised study. All patients will have the following treatments:
Week one: Three treatments with AN69ST (with usual
Sponsors
Gambro Industries (France)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients suffering from chronic renal failure 2. Patients treated in Haemodialysis (HD) unit performed with or without heparin injection in the Extra Corporeal Circuit (ECC) 3. Patients treated three times a week with AN69ST for a minimum of one month 4. Patients 18 years or older 5. Patients with a well-functioning vascular access as judged by the investigator 6. Signed written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patients with known allergy to heparin 2. Patients with acute inflammatory event that may affect, as judged by the investigator, the results of the study or the safety of the patients 3. Pregnant women, nursing mothers and women planning a pregnancy during the course of the study 4. Patients under guardianship 5. Patients participating in other studies that could interfere with the objectives of this study 6. Patients treated in single needle mode 7. Patients treated in HD with low molecular weight heparin injection in the ECC 8. Patients with catheter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, particularly related to bleeding and premature clotting | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Questionnaire to hospital staff regarding priming procedure 2. Dialysance-easurement 3. Rinse back evaluations | — |
Countries
Belgium, France
Outcome results
None listed