Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT05740150
Eligibility Criteria:
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 access port 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 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 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.
* Primary immunological disorder
* Contra indications: known hypersensitivity to taurolidine, citrate or heparin, and a history of heparin-induced thrombocytopenia.
* Documented bacteremia in the period from 24h before catheter insertion until inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
18 Years
Study:
NCT05740150
Study Brief:
Protocol Section:
NCT05740150