Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.

Last updated: February 13, 2023
Sponsor: Princess Maxima Center for Pediatric Oncology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT05740150
NL2365.041.26
12617
NTR668
  • Ages < 18
  • All Genders

Study Summary

The goal of this assessor blinded randomized controlled trial is to compare a lock solution containing taurolidine, citrate and heparin to a heparin only lock solution for the prevention of central line associated bloodstream infections in paediatric oncology patients with a central venous access device.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 0 - <19 years
  • Radiological, cytological or histological proven paediatric malignancy (hematologic,solid, and neurologic malignancies)
  • Tunnelled external central venous access device or totally implantable venous accessport to be inserted at the Princess Máxima Center for Pediatric Oncology
  • Planned central venous access device insertion of >90 days
  • Written consent signed according to local law and regulations
  • Parents/guardians or patient are willing and able to comply with the trial procedure

Exclusion

Exclusion Criteria:

  • A previous central venous access device removed < 12 months ago.
  • Expected treatment for a majority of the follow-up time in a different hospital thanthe Princess Maxima Center for pediatric oncology in the first 90 days of inclusionresulting in difficulties/the inability to visit the Princess Maxima Center at leastonce every 3 weeks.
  • Primary immunological disorder
  • Contra indications: known hypersensitivity to taurolidine, citrate or heparin, and ahistory of heparin-induced thrombocytopenia.
  • Documented bacteremia in the period from 24h before catheter insertion until inclusion

Study Design

Total Participants: 462
Study Start date:
October 27, 2020
Estimated Completion Date:
December 01, 2023

Connect with a study center

  • Princess Máxima Center for Pediatric Oncology

    Utrecht, 3511XK
    Netherlands

    Active - Recruiting

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