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Clinical trial

Evaluation of the Efficacy of an inTerdialytic "Ethanol 40% v/v - enoxapaRin 1000 U/mL" Lock solutioN to Prevent Tunnelled Catheter Infections in Chronic Hemodialysis Patients: a mulTi-centre, Randomized, Single Blind, Parallel Group studY (ETERNITY)

ID
Name
CHU-0307
Description
The purpose of this study is to assessed the efficacy of a combined solution of ethanol (4%) and low molecular weight heparins LMWH in preventing tunnelled dialysis catheter infection in chronic hemodialysis patients
Trial arms
Trial start
2018-02-09
Estimated PCD
2026-12-01
Trial end
2027-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Ethanol
An ethanol 40 % v/v - enoxaparin 1000 U/mL (Ethenox) interdialytic lock solution
Arms:
Intervention group
enoxaparin
An ethanol 40 % v/v - enoxaparin 1000 U/mL (Ethenox) interdialytic lock solution
Arms:
control group
Size
400
Primary endpoint
Time to first TC infection (TCI)
at 1 year
Eligibility criteria
Inclusion Criteria: * end-stage renal disease * chronic hemodialysis/hemodiafiltration at least three times a week * functional TC inserted for at least two weeks * Social security cover * Written informed consent Exclusion Criteria: -
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}
Updated at
2023-12-08

1 organization

2 products

1 indication

Organization
University Hospital Clermont-Ferrand
Product
Ethanol
Indication
Tunneled Hemodialysis Catheter Infection
Product
enoxaparin