Back to resultsMulticenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia (MODIATIH)
Primary Purpose
Dialysis; Complications, Heparin-induced Thrombocytopenia, Chronic Renal Failure
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hydrolink NV membrane
Sponsored by
About this trial
This is an interventional treatment trial for Dialysis; Complications
Eligibility Criteria
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
Sites / Locations
- Hôpital Privé Claude Galien
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
end-stage renal disease patients with heparin-induced thrombocytopenia
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05586854
First Posted
October 17, 2022
Last Updated
October 17, 2022
Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
1. Study Identification
Unique Protocol Identification Number
NCT05586854
Brief Title
Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia
Acronym
MODIATIH
Official Title
Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 20, 2022 (Anticipated)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dialysis; Complications, Heparin-induced Thrombocytopenia, Chronic Renal Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
interventional, prospective, multicentre, longitudinal, non-comparative study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
end-stage renal disease patients with heparin-induced thrombocytopenia
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Hydrolink NV membrane
Intervention Description
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).
Primary Outcome Measure Information:
Title
The occurrence, or not, of a success of the dialytic technique.
Description
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.
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
0683346567
Email
jeanfrancois.oudet@free.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Hôpital Privé Claude Galien
City
Quincy-sous-Sénart
ZIP/Postal Code
91480
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy ROSTOKER, Dr
Phone
06 03 00 42 91
Email
rostotom@orange.fr
12. IPD Sharing Statement
Learn more about this trial
Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia
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