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NCT07587593
The IVCare Adaptive Platform Trial
Conditions: Device Related Infection, Vascular Access Complication, Device Related Sepsis, Catheter Infection
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 2500
Sponsor: The University of Queensland
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 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.
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 \
Source: ClinicalTrials.gov (NCT07587593). StuddyBuddy aggregates publicly available trial information.