Reduction of Heparin Dose in Dialysis With Evodial System (RHODES)
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Pilot, Prospective, Multicenter, Open and Non-randomised Study: Definition of an Index of Anti Xa Value at the End of Hemodialysis Treatment.|
- The primary criterion is the measurement of Anti Xa at the end of dialysis sessions. [ Time Frame: End of dialysis treatment ]
- Follow-up of aPTT for patients treated with UFH, [ Time Frame: Kinetic on single dialysis treatment ]
- Evaluation of TAT (Thrombin-Antithrombin) complex, [ Time Frame: Kinetic on single dialysis treatment ]
- Follow-up of ionic clearance (Diascan) measurements during HD sessions, [ Time Frame: Kinetic of single dialysis treatment ]
- Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale, [ Time Frame: End of dialysis treatment ]
- Follow-up of AE/SAE. [ Time Frame: All treatments during study period ]
|Study Start Date:||September 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Treatment with Evodial with reduction of heparin across study period
Device: Evodial hemodialysers and Evodia blood lines
Maximum 8 weeks treatment with Evodial dialysers with reduction of heparin dose
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781690
|Calydial dialysis unit|
|Irigny, France, 69540|
|Clinique St Exupéry|
|Toulouse, France, 31400|
|Vandoeuvre les Nancy, France, 54511|
|ALTIR Dialysis center|
|Vandoeuvre Les Nancy, France|
|Hannover, Germany, 30625|
|Borgo Trento Hospital|
|Study Chair:||Michèle Kessler, Pf||Hopital Brabois, Vandoeuvre les Nancy|