Evaluation of the Efficacy of an inTerdialytic "Ethanol 40% v/v - enoxapaRin 1000 U/mL" Lock solu… (NCT03083184) | Clinical Trial Compass
RecruitingPhase 3
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
France400 participantsStarted 2018-02-09
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a lock solution that combines 40% ethanol and enoxaparin to prevent infections in tunnelled hemodialysis catheters — is my catheter type and my current infection risk profile the kind this study is designed for, and would it be worth discussing whether I might be eligible?
2Since this is a Phase 3 trial, what do we already know about the safety of putting an ethanol-enoxaparin solution into the catheter between dialysis sessions, and are there any bleeding or alcohol-related risks I should specifically understand given my health history?
3The trial is measuring how long it takes until a first catheter infection happens — how does that outcome compare to what I'm already experiencing or risking with my current catheter lock solution, and what would switching to a study lock mean for my day-to-day dialysis routine?
4If I took part in this trial, how often would I need extra monitoring or clinic visits beyond my regular dialysis schedule, and is that realistic given my situation?
5Would you recommend I consider this trial before trying any other available strategies to prevent catheter infections, or are there standard-of-care options I should try first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.