Pilot, prospective, multicentre, open and non-randomised study: definition of an index of AntiXa value at the end of haemodialysis treatment

ISRCTN	ISRCTN93952087
DOI	https://doi.org/10.1186/ISRCTN93952087
ClinicalTrials.gov (NCT)	NCT00781690
Protocol serial number	1456
Sponsor	Gambro Lundia AB (Sweden)
Funder	Gambro Lundia AB (Sweden)

Submission date: 03/07/2008
Registration date: 25/07/2008
Last edited: 11/04/2019

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Michele Kessler
Scientific

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

Study information

Primary study design	Interventional
Study design	Prospective open non-randomised pilot multi-centre study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	-
Study acronym	RHODES
Study objectives	Assessment of systemic heparin dose decrease during haemodialysis.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	To collect data to define a statistical index of Anti Xa (SIAX) value, at the end of HD treatment, performed without any coagulation issues.
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key 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
Key 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)
Date of first enrolment	01/08/2008
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

France
Germany
Italy
Sweden

Study participating centre

CHU Brabois Nancy

Vandoeuvre
54511
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?
Results article	results	01/10/2003	14/02/2019	Yes	No
Results article	results	01/06/2008	14/02/2019	Yes	No
Results article	results	01/04/2013	14/02/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/04/2019: Internal review.
14/02/2019: Publication references added.