CATERPILLAR: Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)
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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.
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Active Comparator: Heparin lock (heparin 100 IU/mL)
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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.
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Outcome Measures
Primary Outcome Measures
- Incidence of central line associated bloodstream infections [From central venous access device insertion until the end of follow-up (maximum of 90 days).]
Secondary Outcome Measures
- Time to first central line associated bloodstream infection [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 [From central venous access device insertion until the end of follow-up (maximum of 90 days).]
- Incidence of symptomatic central venous thrombosis [From central venous access device insertion until the end of follow-up (maximum of 90 days).]
- Incidence of bacteraemia [From central venous access device insertion until the end of follow-up (maximum of 90 days).]
- Incidence of local infections [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 [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 [From central venous access device insertion until the end of follow-up (maximum of 90 days).]
- Cultured microorganisms causing central line associated bloodstream infections [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 [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 [From central venous access device insertion until the end of follow-up (maximum of 90 days).]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 0 - <19 years
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Radiological, cytological or histological proven paediatric malignancy (hematologic, solid, and neurologic malignancies)
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Tunnelled external central venous access device or totally implantable venous access port to be inserted at the Princess Máxima Center for Pediatric Oncology
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Planned central venous access device insertion of >90 days
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Written consent signed according to local law and regulations
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Parents/guardians or patient are willing and able to comply with the trial procedure
Exclusion Criteria:
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A previous central venous access device removed < 12 months ago.
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Expected treatment for a majority of the follow-up time in a different hospital than the Princess Maxima Center for pediatric oncology in the first 90 days of inclusion resulting in difficulties/the inability to visit the Princess Maxima Center at least once every 3 weeks.
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Primary immunological disorder
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Contra indications: known hypersensitivity to taurolidine, citrate or heparin, and a history of heparin-induced thrombocytopenia.
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Documented bacteremia in the period from 24h before catheter insertion until inclusion
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Princess Máxima Center for Pediatric Oncology | Utrecht | Netherlands | 3511XK |
Sponsors and Collaborators
- Princess Maxima Center for Pediatric Oncology
- Dutch Cancer Society
- UMC Utrecht
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL2365.041.26
- NTR668
- 12617