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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
462
The TauroLock-Hep100 is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.
The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.
Princess Máxima Center for Pediatric Oncology
Utrecht, Netherlands
RECRUITINGIncidence of central line associated bloodstream infections
Time frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Time to first central line associated bloodstream infection
Time frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Central line associated bloodstream infection incidence per 1,000 central venous access device-days
Time frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of symptomatic central venous thrombosis
Time frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of bacteraemia
Time frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of local infections
Time frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Dispense of thrombolysis/systemic antibiotic treatment due to central line associated bloodstream infections/ central venous thrombosis
Time frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of and reasons for central venous access device-removal
Time frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Cultured microorganisms causing central line associated bloodstream infections
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Time frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Days of hospital admission due to central line associated bloodstream infections/ central venous thrombosis
Time frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Safety in terms of known side effects, severe adverse events, intensive care unit admission, and mortality rate due to central line associated bloodstream infections/central venous thrombosis
Time frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).