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.
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Participants who have or require a CVAD, including a peripherally inserted central catheter (PICC), non-tunnelled or tunnelled central venous catheter (CVC), or totally implanted venous access port, are eligible for the IVCare trial. Participation in the observational cohort is a core component of trial participation and occurs for all enrolled participants. Participation in intervention domains is optional. Participants may be enrolled in more than one intervention domain concurrently.
Each domain has its own inclusion and exclusion criteria in addition to core eligibility requirements. Participants will be followed for up to 180 days from enrolment into the observational cohort or randomisation to one or more interventions.
Participants who complete follow-up in the observational cohort and/or one or more intervention domains may be eligible for re-entry, provided they meet eligibility criteria.
There is no fixed sample size for this adaptive platform trial. Recruitment into each domain will be guided by pre-specified interim analyses of accumulating data using Bayesian methods. Predefined decision rules will determine adaptations, including early stopping for futility, non-inferiority, or superiority of interventions within each domain.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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 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.
Cancer stratum inclusion criteria:
- Confirmed diagnosis of a solid tumour OR
- Confirmed diagnosis of a haematological malignancy. OR
- Bone marrow failure syndrome requiring systemic therapy, immunosuppression, or haematopoietic stem cell transplantation.
Kidney stratum exclusion criteria:
• Confirmed diagnosis of kidney disease.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 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.
|
|
Experimental: Connectors/Caps Domain - InVision-Plus CS® for the cancer stratum
|
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.
|
|
Experimental: Connectors/Caps Domain - ClearGuard™ HD for the kidney stratum
|
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.
|
|
Experimental: Connectors/Caps Domain - Tego™ for the kidney stratum
|
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.
|
|
Aktiver Komparator: 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.
|
|
Experimental: Securement Domain - 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Central Line-Associated Bloodstream Infection (CLABSI)
Zeitfenster: Up to 180 days
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Positive blood cultures
Zeitfenster: Up to 180 days
|
Any positive blood culture classified as contaminant, CLABSI, non-CLABSI primary bloodstream infection, mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI), or secondary bloodstream infection, consistent with the CDC NHSN criteria from January 2026
|
Up to 180 days
|
|
Catheter-related infection
Zeitfenster: 180 days
|
Catheter-related infection consistent with the Catheter Related Infection definitions (CRI1, CRI2, and CRI3) from the European Centre for Disease Prevention and Control (ECDC) version 1.02 from 2015
|
180 days
|
|
Central Venous Catheter (CVC) exit site infection
Zeitfenster: Up to 180 days
|
CVC exit site infection consistent with the Infectious Diseases Society of America (IDSA) guidelines from 2009
|
Up to 180 days
|
|
Pocket site infection
Zeitfenster: Up to 180 days
|
Pocket site infection consistent with the IDSA guidelines from 2009
|
Up to 180 days
|
|
CVAD failure
Zeitfenster: Up to 180 days
|
CVAD failure defined as a composite measure of CLABSI and any other infectious or non-infectious complication leading to CVAD removal.
|
Up to 180 days
|
|
CVAD complications not requiring removal
Zeitfenster: Up to 180 days
|
CVAD complications not requiring removal, defined as a composite measure of any complication not requiring CVAD removal.
|
Up to 180 days
|
|
CVAD insertion complications
Zeitfenster: Up to 180 days
|
CVAD insertion complications, defined as a composite measure of any insertion complications.
|
Up to 180 days
|
|
Health-related quality of life
Zeitfenster: Up to 180 days
|
Assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
|
Up to 180 days
|
|
Patients' experiences of care
Zeitfenster: Up to 180 days
|
Assessed using the Australian Hospital Patient Experience Question Set (AHPEQS)
|
Up to 180 days
|
|
CVAD-related Serious Adverse Events (SAEs)
Zeitfenster: Up to 180 days
|
Any SAE considered related or possible related to the CVAD.
|
Up to 180 days
|
|
Intervention-related SAEs
Zeitfenster: Up to 180 days
|
Any SAE considered related or possibly related to an intervention within the Connectors/Caps or the Securement domain.
|
Up to 180 days
|
|
Unanticipated Serious Adverse Device Effect (USADEs)
Zeitfenster: Up to 180 days
|
Any SAE which meets the definition of an USADE.
|
Up to 180 days
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IPVA_26_01
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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