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
Recruiting
Phase 3
Interventional Study
Tunnelled Hemodialysis Catheter Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 400 (estimated)
- Sponsor
- University Hospital, Clermont-Ferrand · Other
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About This Trial
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 Locations
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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:
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Contacts