Reduction of Heparin Dose in Dialysis With Evodial System
Information source: Gambro Lundia AB
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Failure
Intervention: Evodial hemodialysers and Evodia blood lines (Device)
Phase: Phase 4
Status: Recruiting
Sponsored by: Gambro Lundia AB Official(s) and/or principal investigator(s):
Michèle Kessler, Pf, Study Chair, Affiliation: Hopital Brabois, Vandoeuvre les Nancy
Overall contact:
Nathalie Loughraïeb, Email: nathalie.loughraieb@gambro.com
Summary
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.
Clinical Details
Official title: Pilot, Prospective, Multicenter, Open and Non-Randomised Study: Definition of an Index of Anti Xa Value at the End of Hemodialysis Treatment.
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: The primary criterion is the measurement of Anti Xa at the end of dialysis sessions.
Secondary outcome: Follow-up of aPTT for patients treated with UFH,Evaluation of TAT (Thrombin-Antithrombin) complex, Follow-up of ionic clearance (Diascan) measurements during HD sessions, Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale, Follow-up of AE/SAE.
Detailed description:
In parallel to the new hemodialyzer, Evodia blood lines were developed to improve
characteristics of the extracorporeal circuit in term of reduced activation of the
coagulation system and lower deposits of clot components.
The aim is to provide a system (hemodialyzer and extracorporeal circuit) with a low
thrombogenicity and that can be used with low heparin dose in order to reduce the patients'
bleeding risk at the end of HD treatment.
Measurements of TAT (Thrombin-Antithrombin), the marker of the activation of the
coagulation, will be performed during the study in order to evaluate the thrombogenicity of
the system.
The ionic clearance will be collected during all treatments to evaluate the performance of
the hemodialyzer.
The study will be divided into three steps
- Period 1: Usual heparin dose with usual hemodialyzer and standard blood lines
(baseline),
- Period 2: Decrease of heparin dose with Evodial hemodialyzer and standard bloodlines
- Period 3: Lowest heparin dose defined in step 2 using the system Evodial hemodialyzer
and SMA bloodlines.
Each patient included into the study will perform the three steps. As the risk of
extracorporeal circuit clotting will be rather important, no control group (usual
hemodialyzer with heparin decrease dose) will be performed.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
Nathalie Loughraïeb, Email: nathalie.loughraieb@gambro.com
Hopital Brabois, Vandoeuvre les Nancy 54511, France; Recruiting
Thanh Cao Huu, Dr
Thanh Cao Huu, Dr, Principal Investigator
Calydial dialysis unit, Irigny 69540, France; Active, not recruiting
Clinique St Exupéry, Toulouse 31400, France; Recruiting
Françoise Moussion, Dr
Jean-Louis Lacombe, Dr, Principal Investigator
Calydial Dialysis Center, Vienne 38209, France; Active, not recruiting
Medizinische Hochschule, Hannover 30625, Germany; Not yet recruiting
Kielstein, Dr
Haller, Pf, Principal Investigator
Borgo Trento Hospital, Verona, Italy; Not yet recruiting
Loschiavo, Dr
Loschiavo, Dr, Principal Investigator
Karolinska Hospital, Stockholm, Sweden; Active, not recruiting
Additional Information
Related publications: 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. 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.
Starting date: September 2008
Ending date: October 2009
Last updated: June 15, 2009
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