Evaluation of the biocompatibility of cartridge blood set versus standard blood line: A pilot monocentric open randomized and cross-over study

Not Applicable

Completed

• Conditions: Chronic renal failure/ hemodialysis; Urological and Genital Diseases

• Registration Number: ISRCTN15261860
• Lead Sponsor: Gambro (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-01
• Study Completion: 2008-04-30
• Last Update Posted: 4 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Patients suffering from chronic renal failure
2. Patients treated in HemoDialysis (HD) performed with or without heparin injection in the Extra Corporeal Circuit (ECC) irrespective the type of heparin (UFH and LMWH)
3. Patients treated 3 times a week with high-flux membrane for a minimum of 3 months
4. Patients 18 years or older
5. Patients with a well-functioning vascular access as judged by the investigator
6. Patients with negative serologies (HIV, hepatitis)
7. Patients having signed written informed consent to participate in the study

Exclusion Criteria

1. Patients with known allergy to heparin
2. Patients with acute inflammatory event that may affect, as judged by the investigator, the results of the study or the safety of the patients
3. Active malignant disease
4. Pregnant women, nursing mothers and women planning a pregnancy during the course of the study
5. Patients under guardianship
6. Patients participating in other studies that could interfere with the objectives of this study
7. Patients treated in single needle mode
8. Patients with catheter
9. Patients receiving Anti-Vit K drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified