The IVCare Adaptive Platform Trial

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.

Conditions

• Device Related Infection
• Vascular Access Complication
• Device Related Sepsis
• Catheter Infection

Interventions

DEVICE

InVision-Plus CS®

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.

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

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.

Sponsors & Collaborators

• Bayside Health

  collaborator OTHER_GOV

• Monash Medical Centre

  collaborator OTHER

• Princess Alexandra Hospital, Brisbane, Australia

  collaborator OTHER

• Liverpool Hospital, South Western Sydney Local Health District

  collaborator UNKNOWN

• Royal Brisbane and Women's Hospital

  collaborator OTHER_GOV

• Royal North Shore Hospital

  collaborator OTHER

• The University of Queensland

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-12-01

Primary Completion

2031-12-01

Completion

2031-12-01

FDA Device

Yes