Chronic Kidney Failure Clinical Trial
— RHODESOfficial title:
Pilot, Prospective, Multicenter, Open and Non-randomised Study: Definition of an Index of Anti Xa Value at the End of Hemodialysis Treatment.
Verified date | May 2017 |
Source | Baxter Healthcare Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer. Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.
Status | Completed |
Enrollment | 53 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria - Patients suffering from chronic renal failure, - Patients treated in HD three times a week for at least 3 months, with a stable heparin dose and the same filter, - Patients treated in 4-4.5 hours HD mode with a blood flow between 300-350 ml/min, - Patients for whom either LMWH (Enoxaparin, Nadroparin, Tinzaparin) or UFH is used, - Patients with a well-functioning vascular access as judged by the investigator, - Patients treated either on AK, Innova or Integra dialysis machines equipped with ionic dialysance device, - Patients older than 18 years, - Patients with negative serologies (AIDS, Hepatitis) - Patients having signed consent to participate in the study. Exclusion criteria - Patient with HIT or known heparin allergy, - Patient treated in HD in single needle mode, - Patients with catheter, - Patients with acute inflammatory event that may affect, as judged by investigator patients' safety or study results, - Patients participating in other studies that could interfere with the objective of this study, - Patients with active malignant disease, - Patients receiving heparin outside dialysis treatment, - Patients under guardianship, - Pregnant women, nursing mothers and women planning a pregnancy during the course of this study, - Patients with serious history of coagulopathy, - Patients receiving Anti-Vitamin K medication, - Patients receiving an association of anti platelets agents, - 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). |
Country | Name | City | State |
---|---|---|---|
France | Calydial dialysis unit | Irigny | |
France | Clinique St Exupéry | Toulouse | |
France | ALTIR Dialysis center | Vandoeuvre Les Nancy | |
France | Hopital Brabois | Vandoeuvre les Nancy | |
Germany | Medizinische Hochschule | Hannover | |
Italy | Borgo Trento Hospital | Verona | |
Sweden | Karolinska Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Baxter Healthcare Corporation | Gambro Lundia AB |
France, Germany, Italy, Sweden,
Chanard J, Lavaud S, Maheut H, Kazes I, Vitry F, Rieu P. The clinical evaluation of low-dose heparin in haemodialysis: a prospective study using the heparin-coated AN69 ST membrane. Nephrol Dial Transplant. 2008 Jun;23(6):2003-9. Epub 2007 Dec 21. — View Citation
Lavaud S, Canivet E, Wuillai A, Maheut H, Randoux C, Bonnet JM, Renaux JL, Chanard J. Optimal anticoagulation strategy in haemodialysis with heparin-coated polyacrylonitrile membrane. Nephrol Dial Transplant. 2003 Oct;18(10):2097-104. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary criterion is the measurement of Anti Xa at the end of dialysis sessions. | End of dialysis treatment | ||
Secondary | Follow-up of aPTT for patients treated with UFH, | Kinetic on single dialysis treatment | ||
Secondary | Evaluation of TAT (Thrombin-Antithrombin) complex, | Kinetic on single dialysis treatment | ||
Secondary | Follow-up of ionic clearance (Diascan) measurements during HD sessions, | Kinetic of single dialysis treatment | ||
Secondary | Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale, | End of dialysis treatment | ||
Secondary | Follow-up of AE/SAE. | All treatments during study period |
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