Condition category
Urological and Genital Diseases
Date applied
09/01/2008
Date assigned
01/02/2008
Last edited
02/01/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Nathalie Loughraieb

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00804453

Protocol/serial number

1455

Study information

Scientific title

Acronym

Study hypothesis

Improvement of biocompatibility with cartridge blood set.

Ethics approval

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)

Study design

Open randomised cross-over monocentric pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/02/2008

Overall trial end date

30/04/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

Participant 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

Recruitment start date

15/02/2008

Recruitment end date

30/04/2008

Locations

Countries of recruitment

France

Trial participating centre

Gambro Industries
Lyon
69357
France

Sponsor information

Organisation

Gambro (France)

Sponsor details

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

Sponsor type

Industry

Website

http://www.gambro.com/int/

Funders

Funder type

Industry

Funder name

Gambro (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes