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

Not Applicable

Not yet recruiting

• Conditions: Dialysis; Complications; Heparin-induced Thrombocytopenia; Chronic Renal Failure
• Interventions: Procedure: Hydrolink NV membrane

• Registration Number: NCT05586854
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Last Update Submitted: 2022-10-17
• Study First Posted: 2022-10-19
• Last Update Posted: 2022-10-19
• Study Start: 2022-11-20
• Primary Completion: 2023-11-20
• Study Completion: 2024-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
end-stage renal disease patients with heparin-induced thrombocytopenia	Hydrolink NV membrane	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.

Primary Outcome Measures

Name	Time	Method
The occurrence, or not, of a success of the dialytic technique.	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.

Trial Locations

Locations (1)

Hôpital Privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, France