Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia
NCT ID: NCT05586854
Last Updated: 2022-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-11-20
2024-06-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Hydrolink NV membrane
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).
Interventions
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Hydrolink NV membrane
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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European Clinical Trial Experts Network
OTHER
Ramsay Générale de Santé
OTHER
Responsible Party
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Locations
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Hôpital Privé Claude Galien
Quincy-sous-Sénart, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A00610-41
Identifier Type: -
Identifier Source: org_study_id
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