The IVCare Adaptive Platform Trial

Official title

Comparative Effectiveness of Interventions to Prevent Infections and Other Complications Arising From Central Venous Access Devices: the IVCare Adaptive Platform Trial.

Overview

The IVCare trial is a multicentre adaptive platform study evaluating interventions to prevent infections and other complications associated with central venous access devices (CVADs) in patients with newly inserted or existing devices. The study is organised into domains addressing different aspects of CVAD care and includes patient groups referred to as strata. Domains, strata and interventions may change over time as the study progresses. IVCare also includes an observational cohort study in which patients with CVADs are followed to assess CVAD care practices, infections, and other CVAD-related complications across health services. The trial starts with two domains. The Connectors/Caps Domain compares antimicrobial connectors and caps with standard-of-care connectors and caps used in Australian hospitals. In the cancer stratum, participants are randomised to receive either Curos™ or standard-of-care connectors/caps. In the kidney disease stratum, participants are randomised to receive either ClearGuard™ HD or standard-of-care connectors/caps. Following a predefined stopping decision for ClearGuard™ HD in the kidney disease stratum, Tego™ will be introduced and evaluated in this group. The Securement Domain compares the effectiveness of SecurAcath®, a subcutaneous anchor securement system, with standard-of-care securement methods used in Australian hospitals. Participants in both the cancer and kidney disease strata are randomised to receive either SecurAcath® or standard-of-care securement.

Detailed description

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.

Interventions

• Device Connectors/Caps Domain - Standard of Care
  Any needle-free or closed-system connector or cap that does not contain antimicrobial agents and does not incorporate specific infection-prevention design features.
• Device Curos™
  Curos™ is a passive disinfecting cap intended for use with needleless connectors The cap contains 70% isopropyl alcohol. Its intended mechanism of action is to provide continuous antimicrobial protection of the connector surface between line accesses and act as a physical barrier to contamination, thereby reducing the potential for microbial transmission through the catheter hub
• Device ClearGuard™ HD
  The ClearGuard™ HD cap is designed for use with haemodialysis catheters. It attaches to compatible catheter hubs to maintain a closed system between dialysis sessions. The cap is coated with chlorhexidine, which is intended to reduce microbial colonisation at the catheter hub interface.
• Device Tego™
  Tego™ is a needle-free capping device that closes the end of a catheter, creating a mechanically and microbiologically closed system when attached to the catheter hub.
• Device Securement Domain - Standard of Care
  Basic securement using sterile tape/adhesion fixation device and a simple transparent dressing, without antimicrobial, antiseptic, or engineered stabilization features.
• Device SecurAcath®
  SecurAcath® is a subcutaneous catheter securement system. The device utilises a small anchor (securement feet) placed just beneath the skin at the catheter insertion site and then attached to the catheter shaft. It mechanically stabilises the catheter, reducing movement and migration.

Primary outcome measures

• Central Line-Associated Bloodstream Infection (CLABSI) [Time frame: Up to 180 days]

Secondary outcome measures (12)

• Positive blood cultures [Time frame: Up to 180 days]
• Catheter-related infection [Time frame: 180 days]
• Central Venous Catheter (CVC) exit site infection [Time frame: Up to 180 days]
• Pocket site infection [Time frame: Up to 180 days]
• CVAD failure [Time frame: Up to 180 days]
• CVAD complications not requiring removal [Time frame: Up to 180 days]
• CVAD insertion complications [Time frame: Up to 180 days]
• Health-related quality of life [Time frame: Up to 180 days]
• Patients' experiences of care [Time frame: Up to 180 days]
• CVAD-related Serious Adverse Events (SAEs) [Time frame: Up to 180 days]
• Intervention-related SAEs [Time frame: Up to 180 days]
• Unanticipated Serious Adverse Device Effect (USADEs) [Time frame: Up to 180 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07587593 · IPVA_26_01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗