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

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia

Conditions
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Dialysis; Complications, Heparin-induced Thrombocytopenia, Chronic Renal Failure

Intervention / Treatment
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* Procedure: Hydrolink NV membrane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: interventional, prospective, multicentre, longitudinal, non-comparative study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: end-stage renal disease patients with heparin-induced thrombocytopenia<br>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. | Procedure: Hydrolink NV membrane<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence, or not, of a success of the dialytic technique. | 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 |