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

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ClinicalTrials.gov Identifier: NCT00804453
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Gambro Lundia AB
Information provided by (Responsible Party):
Baxter Healthcare Corporation

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

Condition or disease Intervention/treatment Phase
Chronic Kidney Failure Device: Cartridge blood set Device: Standard blood line Not Applicable

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  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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



Primary Outcome Measures :
  1. The biocompatibility will be followed, during dialysis treatment, by measuring TAT complex generation. [ Time Frame: During dialysis treatment ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804453


Locations
France
AURAL
Bourgoin Jallieu, France, 38 317
Sponsors and Collaborators
Baxter Healthcare Corporation
Gambro Lundia AB
Investigators
Principal Investigator: Walid Arkouche, Dr AURAL dialysis centre Lyon France

Publications:
Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00804453     History of Changes
Other Study ID Numbers: 1455
ISRCTN15261860
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Baxter Healthcare Corporation:
Chronic Kidney Failure
Hemodialysis
Biocompatibility

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic