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

Primary Purpose

Chronic Kidney Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cartridge blood set
Standard blood line
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Failure focused on measuring Chronic Kidney Failure, Hemodialysis, Biocompatibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AURAL

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Standard blood line

Cartridge blood line

Outcomes

Primary Outcome Measures

The biocompatibility will be followed, during dialysis treatment, by measuring TAT complex generation.

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.

Full Information

First Posted
December 5, 2008
Last Updated
April 4, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Lundia AB
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1. Study Identification

Unique Protocol Identification Number
NCT00804453
Brief Title
Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line
Official Title
Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line: A Pilot Monocentric Open Randomized and Cross-over Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Lundia AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure
Keywords
Chronic Kidney Failure, Hemodialysis, Biocompatibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard blood line
Arm Title
2
Arm Type
Experimental
Arm Description
Cartridge blood line
Intervention Type
Device
Intervention Name(s)
Cartridge blood set
Intervention Description
Once a week
Intervention Type
Device
Intervention Name(s)
Standard blood line
Intervention Description
Once a week
Primary Outcome Measure Information:
Title
The biocompatibility will be followed, during dialysis treatment, by measuring TAT complex generation.
Time Frame
During dialysis treatment
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walid Arkouche, Dr
Organizational Affiliation
AURAL dialysis centre Lyon France
Official's Role
Principal Investigator
Facility Information:
Facility Name
AURAL
City
Bourgoin Jallieu
ZIP/Postal Code
38 317
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16433843
Citation
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.
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Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line

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