Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line
|ClinicalTrials.gov Identifier: NCT00804453|
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Failure||Device: Cartridge blood set Device: Standard blood line||Not Applicable|
Interactions between blood components (cells and proteins) and the extracorporeal circuit induce the activation of several biological systems such as platelets, complement and coagulation cascades. The coagulation system generates a key enzyme, factor IIa or thrombin, responsible for blood clotting in the dialysis circuit Because clotting in the circuit may reduce the dialysis efficiency, the anticoagulation of the extracorporeal circuit is needed .
For several years, most of the researches were mainly focused on the improvement of the biocompatibility of dialysis membranes .
The contribution of the various components of the dialysis circuit on the coagulation activation has not been clearly established.
A circuit integrating a cartridge blood set is commercialised for several years. The design of this cartridge blood set reduces the surface in contact with blood and minimizes the blood air interface which are well known sources of coagulation activation.
The aim of this study is to collect data to evaluate the biocompatibility of two types of blood circuit (cartridge blood set vs standard blood line).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line: A Pilot Monocentric Open Randomized and Cross-over Study.|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Active Comparator: 1
Standard blood line
Device: Standard blood line
Once a week
Cartridge blood line
Device: Cartridge blood set
Once a week
- The biocompatibility will be followed, during dialysis treatment, by measuring TAT complex generation. [ Time Frame: During dialysis treatment ]
- The quality of the restitution of both the filter and the circuit, at the end of each treatment, will be evaluated via visual scales. [ Time Frame: End of dialysis treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804453
|Bourgoin Jallieu, France, 38 317|
|Principal Investigator:||Walid Arkouche, Dr||AURAL dialysis centre Lyon France|