Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatri… (NCT05781295) | Clinical Trial Compass
RecruitingNot Applicable
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
France148 participantsStarted 2024-01-19
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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).
✕
What they're measuring
1
Comparison of the incidence of catheter-related infection per 1000 catheter days.