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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Failure
• Intervention / Treatment: Device: Standard blood line; Device: Cartridge blood set

Detailed Description

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
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bourgoin Jallieu, France, 38 317
    • Aural

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Standard blood line	Device: Standard blood line; Once a week
Experimental: 2; Cartridge blood line	Device: Cartridge blood set; Once a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The biocompatibility will be followed, during dialysis treatment, by measuring TAT complex generation.	During dialysis treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
The quality of the restitution of both the filter and the circuit, at the end of each treatment, will be evaluated via visual scales.	End of dialysis treatment

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Gambro Lundia AB
• Investigators: Principal Investigator: Walid Arkouche, Dr, AURAL dialysis centre Lyon France

Publications and helpful links

General Publications

• Lucchi L, Ligabue G, Marietta M, Delnevo A, Malagoli M, Perrone S, Stipo L, Grandi F, Albertazzi A. Activation of coagulation during hemodialysis: effect of blood lines alone and whole extracorporeal circuit. Artif Organs. 2006 Feb;30(2):106-10. doi: 10.1111/j.1525-1594.2006.00188.x.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: December 5, 2008
• First Submitted That Met QC Criteria: December 5, 2008
• First Posted (Estimate): December 8, 2008

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Hemodialysis; Biocompatibility; Chronic Kidney Failure
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 1455; ISRCTN15261860