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

NCT00804453 | Completed

• 2 other identifiers: 1455ISRCTN15261860
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Failure

Keywords

Chronic Kidney Failure; Hemodialysis; Biocompatibility

Outcome Measures

Primary Outcomes (1)

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

  During dialysis treatment

Secondary Outcomes (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.

  End of dialysis treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Standard blood line

Device: Standard blood line

2

EXPERIMENTAL

Cartridge blood line

Device: Cartridge blood set

Interventions

Cartridge blood set DEVICE

Once a week

2

Standard blood line DEVICE

Once a week

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vantive Health LLC: lead
• Gambro Lundia AB: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

AURAL

Bourgoin, 38 317, France

Location

Related Publications (1)

• 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.

  PMID: 16433843 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Walid Arkouche, Dr

  AURAL dialysis centre Lyon France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

FR (1)