The IVCare Adaptive Platform Trial
Comparative Effectiveness of Interventions to Prevent Infections and Other Complications Arising From Central Venous Access Devices: the IVCare Adaptive Platform Trial.
1 other identifier
interventional
2,500
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2026
CompletedFirst Posted
Study publicly available on registry
May 14, 2026
CompletedStudy Start
First participant enrolled
December 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2031
Study Completion
Last participant's last visit for all outcomes
December 1, 2031
May 14, 2026
May 1, 2026
5 years
May 7, 2026
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Central Line-Associated Bloodstream Infection (CLABSI)
Laboratory confirmed bloodstream infection associated with the study central venous access device (CVAD), with no other source for the infection, consistent with core criteria of the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) from January 2026
Up to 180 days
Secondary Outcomes (12)
Positive blood cultures
Up to 180 days
Catheter-related infection
180 days
Central Venous Catheter (CVC) exit site infection
Up to 180 days
Pocket site infection
Up to 180 days
CVAD failure
Up to 180 days
- +7 more secondary outcomes
Study Arms (6)
Connectors/Caps Domain - Standard of care
ACTIVE COMPARATORConnectors/Caps Domain - InVision-Plus CS® for the cancer stratum
EXPERIMENTALConnectors/Caps Domain - ClearGuard™ HD for the kidney stratum
EXPERIMENTALConnectors/Caps Domain - Tego™ for the kidney stratum
EXPERIMENTALSecurement Domain - Standard of care
ACTIVE COMPARATORSecurement Domain - SecurAcath®
EXPERIMENTALInterventions
Any needle-free or closed-system connector or cap that does not contain antimicrobial agents and does not incorporate specific infection-prevention design features.
InVision-Plus CS® is a needleless intravenous (IV) connector system intended for use in IV and blood administration sets without the use of needles, thereby reducing the risk of needle-stick injuries during use. The device incorporates antimicrobial agents, including silver and chlorhexidine, designed to reduce microbial colonisation on treated surfaces, including the septum and fluid path.
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.
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.
Basic securement using sterile tape/adhesion fixation device and a simple transparent dressing, without antimicrobial, antiseptic, or engineered stabilization features.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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 or silver-containing products.
- Confirmed diagnosis of a solid tumour OR
- Confirmed diagnosis of a haematological malignancy. OR
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Queenslandlead
- Bayside Healthcollaborator
- Monash Medical Centrecollaborator
- Princess Alexandra Hospital, Brisbane, Australiacollaborator
- Liverpool Hospital, South Western Sydney Local Health Districtcollaborator
- Royal Brisbane and Women's Hospitalcollaborator
- Royal North Shore Hospitalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2026
First Posted
May 14, 2026
Study Start (Estimated)
December 1, 2026
Primary Completion (Estimated)
December 1, 2031
Study Completion (Estimated)
December 1, 2031
Last Updated
May 14, 2026
Record last verified: 2026-05