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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 Paediatric Oncology

Recruiting
21 years and younger
All
Phase N/A

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Overview

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.

Description

The patient will be followed according to the type of pathology and the respective treatment protocol either Taurolock or physiological serum at each time cathter will be used.

Eligibility

Inclusion Criteria:

  1. Patient less than or equal to 21 years of age at inclusion.
  2. 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).
  3. Patient treated for a cancer.
  4. Patient with regular follow-up in the inclusion center.
  5. Informed consent signed by the patient if adult or by legal representatives if minor.
  6. Patient benefiting from a social security coverage.
  7. Time between the date of catheter placement and the planned date for the first solution lock injection less than 6 weeks.

Exclusion Criteria:

  1. Patient with retinoblastoma.
  2. Allografted patient.
  3. Patient with a life expectancy of less than 6 months.
  4. Patient refusing to participate in the protocol.
  5. Patient already receiving a central venous catheter-related infection prevention lock (ILCVC).
  6. Patient with known allergy to citrate or (cyclo)-Taurolidine.
  7. Patient taking other drugs with a known contraindication with citrate or (cyclo)-Taurolidine.
  8. Patient with an external femoral catheter.
  9. Patient with a PICCLINE-type peripheral venous inserted central catheter.
  10. Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
  11. Patient under guardianship and curatorship.

Study details
    Children
    Medical Device
    Primary Prevention
    Oncology

NCT05781295

Institut Curie

4 May 2024

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