The IVCare Adaptive Platform Trial (NCT07587593) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The IVCare Adaptive Platform Trial
2,500 participantsStarted 2026-12-01
Plain-language summary
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 chlorhexidine-containing connectors and caps with standard-of-care connectors and caps used in Australian hospitals. In the cancer stratum, participants are randomised to receive either InVision-Plus CS® 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Central Line-Associated Bloodstream Infection (CLABSI)