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

NCT05586854 | Unknown

• 1 other identifier: 2021-A00610-41
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

end-stage renal disease patients with heparin-induced thrombocytopenia

EXPERIMENTAL

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.

Procedure: Hydrolink NV membrane

Interventions

Hydrolink NV membrane PROCEDURE

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).

end-stage renal disease patients with heparin-induced thrombocytopenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jeanfrancois.oudet@free.fr

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: interventional, prospective, multicentre, longitudinal, non-comparative study.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 19, 2022
• Study Start: November 20, 2022
• Primary Completion: November 20, 2023
• Study Completion: June 20, 2024
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

FR (1)