HepZero:Heparin Free Dialysis With Evodial

Vantive Health LLC

Status: Completed

Conditions: Chronic Kidney Disease; Patients Requiring Heparin Free Dialysis Treatments

Treatments: Device: Evodial; Other: Heparin free dialysis technique

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01318486

1483

Details and patient eligibility

About

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.

Enrollment: 265 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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265 participants in 2 patient groups

Heparin free dialysis standard of care

Active Comparator group

Description:

Standard of care: can be either saline flushes or predilution (on-line or bags)

Treatment:

Other: Heparin free dialysis technique

Heparin free dialysis with Evodial

Experimental group

Treatment:

Device: Evodial