Status:
COMPLETED
Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Gambro Lundia AB
Baxter Healthcare Corporation
Conditions:
Chronic Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00804453
Start Date
November 1 2008
End Date
November 1 2008
Last Update
March 13 2025
Active Locations (1)
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1
AURAL
Bourgoin, France, 38 317