Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2008-11-30

Brief Summary

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The primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market.

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Detailed Description

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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).

Conditions

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Chronic Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard blood line

Group Type ACTIVE_COMPARATOR

Standard blood line

Intervention Type DEVICE

Once a week

2

Cartridge blood line

Group Type EXPERIMENTAL

Cartridge blood set

Intervention Type DEVICE

Once a week

Interventions

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Cartridge blood set

Once a week

Intervention Type DEVICE

Standard blood line

Once a week

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from chronic renal failure,
* Patients treated in HD performed with or without heparin injection in the extra corporeal circuit (ECC) irrespective the type of heparin (UFH and LMWH),
* Patients treated three times a week for a minimum of three (3) months,
* Patients 18 years or older,
* Patients with a well-functioning vascular access as judged by the investigator,
* Patients with negative serologies (HIV, hepatitis),
* Patients having signed written informed consent to participate in the study.

Exclusion Criteria

* Patients with known allergy to heparin,
* Patients with acute inflammatory event that may affect, as judged by the investigator, the results of the study or the safety of the patients,
* Active malignant disease,
* Pregnant women, nursing mothers and women planning a pregnancy during the course of the study,
* Patients under guardianship,
* Patients participating in other studies that could interfere with the objectives of this study,
* Patients treated in single needle mode,
* Patients with catheter,
* Patients receiving Anti-Vit K drug.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No