The IVCare Adaptive Platform Trial

Participants who have or require a CVAD, including a peripherally inserted central catheter (PICC), non-tunnelled or tunnelled central venous catheter (CVC), or totally implanted venous access port, are eligible for the IVCare trial.

Participation in the observational cohort is a core component of trial participation and occurs for all enrolled participants. Participation in intervention domains is optional. Participants may be enrolled in more than one intervention domain concurrently.

Each domain has its own inclusion and exclusion criteria in addition to core eligibility requirements. Participants will be followed for up to 180 days from enrolment into the observational cohort or randomisation to one or more interventions.

Participants who complete follow-up in the observational cohort and/or one or more intervention domains may be eligible for re-entry, provided they meet eligibility criteria.

There is no fixed sample size for this adaptive platform trial. Recruitment into each domain will be guided by pre-specified interim analyses of accumulating data using Bayesian methods. Predefined decision rules will determine adaptations, including early stopping for futility, non-inferiority, or superiority of interventions within each domain.

Core inclusion Criteria:

• The patient has or requires a CVAD, including a PICC, a non-tunnelled or tunnelled CVC, or a totally implanted venous access port.
• Patient is less than 18 years old and paediatric recruitment has not been approved at the site.

Securement Domain exclusion criteria:

• Central line-associated bloodstream infection (CLABSI) currently suspected associated with any vascular access device (peripheral or central) that is in situ.
• CLABSI diagnosed from any vascular access device currently in situ within the past 7 days or being actively treated with antimicrobials.
• Participants with an estimated life expectancy of <30 days OR who have commenced a documented end-of-life, terminal-care, or comfort-care pathway.
• Participants who have previously been randomised for the same CVAD.
• Participants who have been randomised three times.
• SecurAcath® cannot be applied in accordance with manufacturer instructions and local policy.
• The participant has compromised skin integrity at the current or intended insertion site, including active infection, inflammation, erosion, ulceration, or pre-existing exit-site injury.

Connectors/Caps Domain exclusion criteria:

• Central line-associated bloodstream infection (CLABSI) currently suspected associated with any vascular access device (peripheral or central) that is in situ.
• CLABSI diagnosed within the past 14 days or CLABSI being actively treated with antimicrobials, associated with any vascular access device currently in situ.
• Participants with an estimated life expectancy of <30 days OR who have commenced a documented end-of-life, terminal-care, or comfort-care pathway.
• Participants who have previously been randomised for the same CVAD.
• Participants who have been randomised three times.
• Known or suspected hypersensitivity or a confirmed allergy to chlorhexidine.

Cancer stratum inclusion criteria:

• Confirmed diagnosis of a solid tumour OR
• Confirmed diagnosis of a haematological malignancy. OR
• Bone marrow failure syndrome requiring systemic therapy, immunosuppression, or haematopoietic stem cell transplantation.

Kidney stratum exclusion criteria:

• Confirmed diagnosis of kidney failure treated with haemodialysis AND
• CVAD expected to remain in place for >14 days.