Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line - Full Text View

Sponsored by:	Gambro Lundia AB
Information provided by:	Gambro Lundia AB
ClinicalTrials.gov Identifier:	NCT00804453

Purpose

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

Condition	Intervention	Phase
Chronic Kidney Failure	Device: Cartridge blood set Device: Standard blood line	Phase IV

MedlinePlus related topics: Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study
Official Title:	Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line: A Pilot Monocentric Open Randomized and Cross-Over Study.

Further study details as provided by Gambro Lundia AB:

Primary Outcome Measures:

The biocompatibility will be followed, during dialysis treatment, by measuring TAT complex generation. [ Time Frame: During dialysis treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Standard blood line	Device: Standard blood line Once a week
2: Experimental Cartridge blood line	Device: Cartridge blood set Once a week

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804453

Locations

France
AURAL
Bourgoin Jallieu, France, 38 317

Sponsors and Collaborators

Gambro Lundia AB

Investigators

Principal Investigator:

Walid Arkouche, Dr

AURAL dialysis centre Lyon France

More Information

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.

Responsible Party:	Gambro Lundia AB ( Nathalie Loughraïeb Study Manager )
Study ID Numbers:	1455, ISRCTN15261860
Study First Received:	December 5, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00804453 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Gambro Lundia AB:

Chronic Kidney Failure
Hemodialysis
Biocompatibility

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009