HepZero study: Heparin Free dialysis with Evodial: A prospective multicenter, open, randomized, controlled clinical study with parallel groups

Phase 4

Completed

• Conditions: Chronic end-stage renal disease; 'renal failure' - 'chronic end-stage renal disease'

• Registration Number: NL-OMON36007
• Lead Sponsor: Gambro Lundia AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified