NCT00781690

Reduction of Heparin Dose in Dialysis With Evodial System

Pilot, Prospective, Multicenter, Open and Non-randomised Study: Definition of an Index of Anti Xa Value at the End of Hemodialysis Treatment.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Failure

Interventions

Type	Name	Description
DEVICE	Evodial hemodialysers and Evodia blood lines	Maximum 8 weeks treatment with Evodial dialysers with reduction of heparin dose

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-10-29
• Last updated: 2025-03-13

Locations

7 sites across 4 countries: France, Germany, Italy, Sweden