Status:
COMPLETED
Reduction of Heparin Dose in Dialysis With Evodial System
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Gambro Lundia AB
Baxter Healthcare Corporation
Conditions:
Chronic Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 decreas...
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 deposi...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00781690
Start Date
September 1 2008
End Date
February 1 2010
Last Update
March 13 2025
Active Locations (7)
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1
Calydial dialysis unit
Irigny, France, 69540
2
Clinique St Exupéry
Toulouse, France, 31400
3
Hopital Brabois
Vandœuvre-lès-Nancy, France, 54511
4
ALTIR Dialysis center
Vandœuvre-lès-Nancy, France