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

Ramsay Générale de Santé

Status: Not yet enrolling

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

Treatments: Procedure: Hydrolink NV membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT05586854

2021-A00610-41

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

end-stage renal disease patients with heparin-induced thrombocytopenia

Experimental group

Description:

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.

Treatment:

Procedure: Hydrolink NV membrane