Reduction of Heparin Dose in Dialysis With Evodial System

Not Applicable

Completed

• Conditions: Chronic Kidney Failure
• Interventions: Device: Evodial hemodialysers and Evodia blood lines

• Registration Number: NCT00781690
• Lead Sponsor: Vantive Health LLC

Brief Summary

The current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer. Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.

Detailed Description

In parallel to the new hemodialyzer, Evodia blood lines were developed to improve characteristics of the extracorporeal circuit in term of reduced activation of the coagulation system and lower deposits of clot components.

The aim is to provide a system (hemodialyzer and extracorporeal circuit) with a low thrombogenicity and that can be used with low heparin dose in order to reduce the patients' bleeding risk at the end of HD treatment.

Measurements of TAT (Thrombin-Antithrombin), the marker of the activation of the coagulation, will be performed during the study in order to evaluate the thrombogenicity of the system.

The ionic clearance will be collected during all treatments to evaluate the performance of the hemodialyzer.

The study will be divided into three steps

* Period 1: Usual heparin dose with usual hemodialyzer and standard blood lines (baseline),

* Period 2: Decrease of heparin dose with Evodial hemodialyzer and standard bloodlines

* Period 3: Lowest heparin dose defined in step 2 using the system Evodial hemodialyzer and SMA bloodlines.

Each patient included into the study will perform the three steps. As the risk of extracorporeal circuit clotting will be rather important, no control group (usual hemodialyzer with heparin decrease dose) will be performed.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-28
• Study First Submitted QC: 2008-10-28
• Study First Posted: 2008-10-29
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Evodial hemodialysers and Evodia blood lines	Treatment with Evodial with reduction of heparin across study period

Primary Outcome Measures

Name	Time	Method
The primary criterion is the measurement of Anti Xa at the end of dialysis sessions.	End of dialysis treatment

Secondary Outcome Measures

Name	Time	Method
Follow-up of aPTT for patients treated with UFH,	Kinetic on single dialysis treatment
Follow-up of ionic clearance (Diascan) measurements during HD sessions,	Kinetic of single dialysis treatment
Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale,	End of dialysis treatment
Evaluation of TAT (Thrombin-Antithrombin) complex,	Kinetic on single dialysis treatment
Follow-up of AE/SAE.	All treatments during study period

Trial Locations

Locations (7)

Karolinska Hospital; 🇸🇪 Stockholm, Sweden

Hopital Brabois; 🇫🇷 Vandoeuvre les Nancy, France

Clinique St Exupéry; 🇫🇷 Toulouse, France

ALTIR Dialysis center; 🇫🇷 Vandoeuvre Les Nancy, France

Calydial dialysis unit; 🇫🇷 Irigny, France

Borgo Trento Hospital; 🇮🇹 Verona, Italy

Medizinische Hochschule; 🇩🇪 Hannover, Germany