Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in the Primary Prevention of Catheter-related Endoluminal Infection in Paediatric Oncology.
Institut Curie
148 participants
Jan 19, 2024
INTERVENTIONAL
Conditions
Summary
Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology. Multicentric, controlled, randomized and double-blind label study.
Eligibility
Inclusion Criteria7
- Patient less than or equal to 21 years of age at inclusion.
- Patient for whom a central catheter is planned to be inserted*, excluding a non-tunneled femoral or cervical external catheter or a peripherally inserted central catheter (as PICC line). *1st catheter placement or placement following a relapse (this placement must take place at least one month after previous catheter removal).
- Patient treated for a cancer.
- Patient with regular follow-up in the inclusion center.
- Informed consent signed by the patient if adult or by legal representatives if minor.
- Patient benefiting from a social security coverage.
- Time between the date of catheter placement and the planned date for the first solution lock injection less than 6 weeks.
Exclusion Criteria11
- Patient with retinoblastoma.
- Allografted patient.
- Patient with a life expectancy of less than 6 months.
- Patient refusing to participate in the protocol.
- Patient already receiving a central venous catheter-related infection prevention lock (ILCVC).
- Patient with known allergy to citrate or (cyclo)-Taurolidine.
- Patient taking other drugs with a known contraindication with citrate or (cyclo)-Taurolidine.
- Patient with an external femoral catheter.
- Patient with a PICCLINE-type peripheral venous inserted central catheter.
- Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
- Patient under guardianship and curatorship.
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Interventions
The patient will be followed up to a maximum of 6 months after randomization after have a TaurolockTM injected each time catheter will be used.
The patient will be followed up to a maximum of 6 months after randomization after have a Physiological serum injected each time catheter will be used.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT05781295