Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients
Phase 4
Completed
- Conditions
- <p>Central line associated bloodstream infection Central venous thrombosis Pediatric oncology</p>10004018
- Registration Number
- NL-OMON20136
- Lead Sponsor
- KWF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 462
Inclusion Criteria
|
Age between 0 - <19 years |
Exclusion Criteria
|
A previous central venous access device removed < 12 months ago. |
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence of first central line associated bloodstream infection</p><br>
- Secondary Outcome Measures
Name Time Method <p>Time to first tunneled Central Line Associated Bloodstream Infection (CLABSI) since the insertion of the Central Venous Access Device (CVAD) CLABSI incidence per 1,000 CVAD-days Incidence of (a)symptomatic Central Venous Thromboses (CVTs) Incidence of bacteremia Dispense of thrombolysis/systemic antibiotic treatment due to CLABSIs/CVTs Incidence of and reasons for CVAD-removal Cultured microorganisms causing CLABSIs Days of hospital admission due to CLABSIs/CVTs Safety of the study locks in terms of known side effects, liver enzymes, severe adverse events (SAEs), intensive care unit admission, and mortality rate due to CLABSIs/CVTs</p><br>