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

Chronic Renal Failure Clinical Trial

— MODIATIH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05586854
• Other study ID #: 2021-A00610-41
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: June 20, 2024

Study information

• Verified date: October 2022
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jeanfrancois.oudet[@]free.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 20, 2024
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Dialysis; Complications
• Heparin-induced Thrombocytopenia
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Thrombocytopenia

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
France	Hôpital Privé Claude Galien	Quincy-sous-Sénart

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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