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

March 11, 2025 updated by: Vantive Health LLC

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bourgoin Jallieu, France, 38 317
        • AURAL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: During dialysis treatment
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.
Time Frame: End of dialysis treatment
End of dialysis treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vantive Health LLC

Collaborators

Baxter Healthcare Corporation
Gambro Lundia AB

Investigators

  • Principal Investigator: Walid Arkouche, Dr, AURAL dialysis centre Lyon France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

December 8, 2008

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1455
  • ISRCTN15261860

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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