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Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line: A Pilot Monocentric Open Randomized and Cross-over Study.
The primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
AURAL
Bourgoin, France
Start Date
November 1, 2008
Primary Completion Date
November 1, 2008
Completion Date
November 1, 2008
Last Updated
March 13, 2025
16
ACTUAL participants
Cartridge blood set
DEVICE
Standard blood line
DEVICE
Lead Sponsor
Vantive Health LLC
Collaborators
Data Source & Attribution
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