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

ISRCTN	ISRCTN15261860
DOI	https://doi.org/10.1186/ISRCTN15261860
ClinicalTrials.gov (NCT)	NCT00804453
Protocol serial number	1455
Sponsor	Gambro (France)
Funder	Gambro (France)

Submission date: 09/01/2008
Registration date: 01/02/2008
Last edited: 01/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Nathalie Loughraieb
Scientific

Gambro Industries
Clinical Affairs Department
61 Avenue Tony Garnier
BP 7315
Lyon
69357
France

Study information

Primary study design	Interventional
Study design	Open randomised cross-over monocentric pilot study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of the biocompatibility of cartridge blood set versus standard blood line: A pilot monocentric open randomized and cross-over study
Study objectives	Improvement of biocompatibility with cartridge blood set.
Ethics approval(s)	Committee for Protection of Research Subjects (Comité de Protection des Personnes [CPP]) Sud-Est III Lyon, approved on 31/01/2008 (ref: 2007-A01253-50)
Health condition(s) or problem(s) studied	Chronic renal failure/ hemodialysis
Intervention	Control: 1 x HD treatment with standard blood line Intervention: 1 x HD treatment with cartridge blood set The participants who receive HD treatment with standard blood line first will have their second HD done using the cartridge blood set, and vice versa (cross-over). Therefore, each participant receives 1 x control and 1 x intervention treatment).
Intervention type	Other
Primary outcome measure(s)	Measurement of Thrombin-AntiThrombin (TAT) complex generation Timepoints of measurement: T0 (before hemodialysis treatment starts), during hemodialysis treatment (at T1h, T2h, T3h, T4h) and just before hemodialysis stops.
Key secondary outcome measure(s)	1. Quality of restitution 2. Follow-up of adverse events (AEs) Timepoints of measurement: T0 (before hemodialysis treatment starts), during hemodialysis treatment (at T1h, T2h, T3h, T4h) and just before hemodialysis stops.
Completion date	30/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	25
Key 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
Key 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
Date of first enrolment	15/02/2008
Date of final enrolment	30/04/2008

Locations

Countries of recruitment

France

Study participating centre

Gambro Industries

Lyon
69357
France

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

01/02/2019: No publications found, verifying study status with the principal investigator