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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15261860

Enrollment

Registered

2008-02-01

Start date

2008-02-15

Completion date

Unknown

Last updated

2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic renal failure/ hemodialysis Urological and Genital Diseases Chronic renal failure/ hemodialysis

Interventions

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 bloo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026