Chronic Renal Failure, Dialysis; Complications, Heparin-induced Thrombocytopenia
Conditions
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.
Interventions
PROCEDUREHydrolink 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).
Sponsors
European Clinical Trial Experts Network
Ramsay Générale de Santé
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
interventional, prospective, multicentre, longitudinal, non-comparative study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
Primary ContactJean-François Oudet
Backup ContactMarie-Hélène Barba
Outcome results
None listed