Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT00781690
Study type Interventional
Source Baxter Healthcare Corporation
Contact
Status Completed
Phase N/A
Start date September 2008
Completion date February 2010

See also
  Status Clinical Trial Phase
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT00806130 - Health Related Quality of Life and Cognitive Function Among Norwegian Dialysis Patients
Completed NCT00153621 - Prevalence of Proteinuria and Chronic Kidney Disease in Pediatric HIV-Infected Patients N/A
Completed NCT06165211 - Nature-Based Sound Application For Hemodialysis Patients N/A
Not yet recruiting NCT04013620 - CNI Transient Replacement by Belatacept From 3 to 12 Months Post Transplantation in Patients With Early Graft Dysfunction Phase 3
Withdrawn NCT03998917 - Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
Completed NCT02586376 - Effects of the Low-level Laser Therapy (LLLT) on Muscle Strength (MS) of the Patients With Kidneys Failure (KF) N/A
Completed NCT00794326 - Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD Phase 3
Completed NCT05185999 - Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Solution in PD Patients Phase 1
Completed NCT03076528 - An Innovative Virtually Supervised Exercise for Dialysis Patients Phase 2
Completed NCT02513303 - Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes Phase 3
Completed NCT00804453 - Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line N/A
Unknown status NCT00788905 - Comparison of Conventional Dialysis and the Allient System N/A
Completed NCT01085552 - Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects Phase 1
Completed NCT00694824 - Vascular Calcification's Risk Factors in Haemodialysis Patients
Completed NCT00074620 - A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis Phase 2
Withdrawn NCT06030050 - Animal Assisted Intervention for Hemodialysis Outpatients N/A
Not yet recruiting NCT05562869 - Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction Phase 3
Completed NCT03437538 - Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter N/A
Completed NCT01450670 - Observational Study of Kibow Biotics in Dialysis Patients