Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.
NCT05740150 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 462
Last updated 2023-02-22
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.
Conditions
- Central Line-associated Bloodstream Infection (CLABSI)
Interventions
- DEVICE
-
TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)
The TauroLock-Hep100 is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.
- DEVICE
-
Heparin lock (heparin 100 IU/mL)
The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.
Sponsors & Collaborators
-
Dutch Cancer Society
collaborator OTHER -
UMC Utrecht
collaborator OTHER -
Princess Maxima Center for Pediatric Oncology
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 0 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-27
- Primary Completion
- 2023-12-01
- Completion
- 2023-12-01
Countries
- Netherlands
Study Locations
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