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 number | NCT00804453 |
| Secondary identifying numbers | 1455 |
- 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
Scientific
Gambro Industries
Clinical Affairs Department
61 Avenue Tony Garnier
BP 7315
Lyon
69357
France
Study information
| Study design | Open randomised cross-over monocentric pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 outcome measures | 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. |
| Overall study start date | 15/02/2008 |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
69357
France
Sponsor information
Gambro (France)
Industry
Industry
Clinical Affairs Department
61 Avenue Tony Garnier
BP 7315
Lyon
69357
France
| Website | http://www.gambro.com/int/ |
|---|---|
"ROR" |
https://ror.org/01mgtdr23 |
Funders
Funder type
Industry
Gambro (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
01/02/2019: No publications found, verifying study status with the principal investigator
