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 number | NCT00781690 |
| Secondary identifying numbers | 1456 |
- 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
Scientific
CHU Brabois Nancy
Service Néphrologie Hémodialyse
Rue du Morvan
Vandoeuvre
54511
France
Study information
| Study design | Prospective open non-randomised pilot multi-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non 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 | - |
| 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 | 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 study start date | 01/08/2008 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
54511
France
Sponsor information
Gambro Lundia AB (Sweden)
Industry
Industry
Magistartsvägen 16
Lund
SE 26-43
Sweden
| Website | http://www.gambro.com/int |
|---|---|
"ROR" |
https://ror.org/05mw5ed57 |
Funders
Funder type
Industry
Gambro Lundia AB (Sweden)
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 |
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 |
Editorial Notes
11/04/2019: Internal review.
14/02/2019: Publication references added.
