- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05586854
Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia (MODIATIH)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Quincy-sous-Sénart, France, 91480
- Hôpital Privé Claude Galien
-
Contact:
- Guy ROSTOKER, Dr
- Phone Number: 06 03 00 42 91
- Email: rostotom@orange.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The occurrence, or not, of a success of the dialytic technique.
Time Frame: 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.
|
7 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A00610-41
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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