Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia (MODIATIH)

October 17, 2022 updated by: Ramsay Générale de Santé

This research is based on the hypothesis that the Hydrolink®-NV dialysis membrane could allow the realization of quality dialysis with a significant reduction in the doses of Orgaran®, or even a total cessation of the anticoagulant, in patients with chronic renal failure. with heparin-induced thrombocytopenia.

Thus, this study aims to show that the use of this dialysis membrane without prior anticoagulation does not increase the risk of coagulation of the circuit and allows the realization of quality dialysis sessions.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Quincy-sous-Sénart, France, 91480
        • Hôpital Privé Claude Galien
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient, male or female, over 18 years of age.
  • Patient on dialysis in a hemodialysis unit of the Ramsay Santé group.
  • Patient with diagnosed heparin induced thrombocytopenia.
  • Patient whose dialysis sessions benefit from extracorporeal circulation anticoagulation with Orgaran® or its equivalent (Arixtra® or Arganova®).
  • Patient informed and having signed his written consent to participate in the study.
  • Affiliated patient or beneficiary of a social security scheme.
  • Woman of childbearing age with effective contraception, after verification of the absence of active pregnancy (negative pregnancy test)

Exclusion Criteria:

  • Patient whose duration of dialysis is less than 1 month.
  • Medically unstable or fragile patient.
  • Patient participating in another clinical study.
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
  • Pregnant, breastfeeding or parturient women.
  • Patient hospitalized without consent.
  • Patient with severe hepatic failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: end-stage renal disease patients with heparin-induced thrombocytopenia
The research procedure consists of dialysing patients on a Hydrolink-NV® membrane with an anticoagulant dose decrease protocol. This protocol of decrease is done over a period of about 6 months divided into 4 periods.

patient dialysis on a Hydrolink-NV® membrane with an anticoagulant dose decrease protocol.

Period 1 : conventional membrane with his usual anticoagulant for 4 weeks. Period 2 : Hydrolink-NV® membrane with maintenance of the previous doses of Orgaran® Period 3 : Hydrolink-NV® membrane with a decrease in Orgaran® Period 4 : Hydrolink-NV® membrane with the minimum effective dose of Orgaran® or without Orgaran® for a period of 3 months (M4, M5, M6).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence, or not, of a success of the dialytic technique.
Time Frame: 7 months
The success of the dialytic technique is defined as the reduction, over the whole of period 4 of the study, of at least 50% of the dose of Orgaran® received by the patient at each dialysis session, compared to to that administered in period 2 of the study.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 20, 2022

Primary Completion (Anticipated)

November 20, 2023

Study Completion (Anticipated)

June 20, 2024

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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