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The IVCare Adaptive Platform Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Interventions: ClearGuard™ HD (Device), Connectors/Caps Domain - Standard of Care (Device), InVision-Plus CS® (Device), SecurAcath® (Device), Securement… to ClearGuard™ HD (Device), Connectors/Caps Domain - Standard of Care (Device), Curos™ (Device), SecurAcath® (Device), Securement Domain…
    • Eligibility criteria expanded, about 9 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07587593
Lead Sponsor The University of Queensland
Collaborators: Bayside Health, Monash Medical Centre, Princess Alexandra Hospital, Brisbane, Australia, Liverpool Hospital, South Western Sydney Local Health District, Royal Brisbane and Women's Hospital, Royal North Shore Hospital
Conditions
(from sponsor)		 Device Related Infection, Vascular Access Complication, Device Related Sepsis, Catheter Infection
Related terms Prosthesis-Related Infections
Enrollment 2,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov