Condition category
Urological and Genital Diseases
Date applied
03/07/2008
Date assigned
25/07/2008
Last edited
01/12/2008
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 Michele Kessler

ORCID ID

Contact details

CHU Brabois Nancy
Service Néphrologie Hémodialyse
Rue du Morvan
Vandoeuvre
54511
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00781690

Protocol/serial number

1456

Study information

Scientific title

Acronym

RHODES

Study hypothesis

Assessment of systemic heparin dose decrease during haemodialysis.

Ethics approval

Ethics approval received from:
1. The Ethics Committee of Stockholm (Sweden) on the 13th June 2008 (ref: 2008/2:5)
2. Local ethics committee (CPP Est III) (France) on the 11th June 2008 (ref: 2008-A00348647)

Ethics approval pending from:
3. Italy: Not yet submitted
4. Germany: Not yet submitted

Study design

Prospective open non-randomised pilot multi-centre study

Primary study design

Interventional

Secondary study design

Non 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

Intervention

There are three periods in this trial:

Period one: usual haemodialysis with usual heparin dose
Period two: participants will have a systematic decrease of heparin dosage during Evodial haemodialysis
Period three: participants will have a systematic decrease of heparin dosage with Evodial system

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To collect data to define a statistical index of Anti Xa (SIAX) value, at the end of HD treatment, performed without any coagulation issues.

Secondary outcome measures

1. To compare the SIAX value according to the different study periods:
1.1. To compare the SIAX obtained with Evodial with the one obtained with usual haemodialyser
1.2. To compare SIAX obtained before and after the heparin dose decrease period
1.3. To compare the SIAX obtained after heparin dose decrease when using SMA blood lines in addition to Evodial haemodialyser
1.4. To compare the SIAX obtained before and after an additional heparin dose decrease period when using SMA blood lines in addition to Evodial haemodialyser
2. To assess the possibility to decrease heparin dose with Evodial
3. To assess the possibility of an additional heparin dose decrease when using SMA blood lines in addition to Evodial haemodialyser
4. To follow product's safety

Exploratory objectives:
5. To assess low-thrombogenicity of Evodial when decreasing heparin
6. To verify that there is no evidence of product efficacy decrease when decreasing heparin
7. To assess Anti Xa and aPTT kinetics according to the level of heparin dose decrease
8. To assess the quality of the restitution according to the level of heparin dose decrease

Overall trial start date

01/08/2008

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients suffering from chronic renal failure
2. Patients treated in haemodialysis (HD) three times a week for at least 3 months, with a stable heparin dose and the same filter
3. Patients treated in 4 - 4.5 hours HD mode with a blood flow between 300 - 350 ml/min
4. Patients for whom either low molecular weight heparin (LMWH) (enoxaparin, nadroparin, tinzaparin) or unfractionated heparin (UFH) is used
5. Patients with a well-functioning vascular access as judged by the investigator
6. Patients treated either on AK, Innova or Integra dialysis machines equipped with ionic dialysance device
7. Patients older than 18 years, either sex
8. Patients with negative serologies (acquired immune deficiency syndrome [AIDS], hepatitis)
9. Patients having signed consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patient with heparin-induced thrombocytopenia (HIT) or known heparin allergy
2. Patient treated in HD in single needle mode
3. Patients with catheter
4. Patients with acute inflammatory event that may affect, as judged by investigator patients' safety or study results
5. Patients participating in other studies that could interfere with the objective of this study
6. Patients with active malignant disease
7. Patients receiving heparin outside dialysis treatment
8. Patients under guardianship
9. Pregnant women, nursing mothers and women planning a pregnancy during the course of this study
10. Patients with serious history of coagulopathy
11. Patients receiving Anti-Vitamin K medication
12. Patients receiving an association of anti-platelets agents
13. Patients with heparin dose that can not be reduced for technical reason (excluding patients receiving too low heparin dose with no possibility of further reduction)

Recruitment start date

01/08/2008

Recruitment end date

31/12/2008

Locations

Countries of recruitment

France, Germany, Italy, Sweden

Trial participating centre

CHU Brabois Nancy
Vandoeuvre
54511
France

Sponsor information

Organisation

Gambro Lundia AB (Sweden)

Sponsor details

Magistartsvägen 16
Lund
SE 26-43
Sweden

Sponsor type

Industry

Website

http://www.gambro.com/int

Funders

Funder type

Industry

Funder name

Gambro Lundia AB (Sweden)

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