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Reduction of Heparin Dose in Dialysis With Evodial System

NCT00781690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-03-13

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Failure

Interventions

DEVICE

Evodial hemodialysers and Evodia blood lines

Maximum 8 weeks treatment with Evodial dialysers with reduction of heparin dose

Sponsors & Collaborators

  • Gambro Lundia AB

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Vantive Health LLC

    lead INDUSTRY

Principal Investigators

  • Michèle Kessler, Pf · Hopital Brabois, Vandoeuvre les Nancy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • France
  • Germany
  • Italy
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00781690 on ClinicalTrials.gov