[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640666":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":61,"collaborators":63,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":11,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":11,"maxAge":11,"enrollmentInfo":86,"targetDuration":11,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":105,"whyStopped":11,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":11},{"fullName":5,"class":6},"The University of Queensland","OTHER",[8,14,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Connectors\u002FCaps Domain - Standard of care","ACTIVE_COMPARATOR",null,[13],"Device: Connectors\u002FCaps Domain - Standard of Care",{"label":15,"type":16,"description":11,"interventionNames":17},"Connectors\u002FCaps Domain - InVision-Plus CS® for the cancer stratum","EXPERIMENTAL",[18],"Device: InVision-Plus CS®",{"label":20,"type":16,"description":11,"interventionNames":21},"Connectors\u002FCaps Domain - ClearGuard™ HD for the kidney stratum",[22],"Device: ClearGuard™ HD",{"label":24,"type":16,"description":11,"interventionNames":25},"Connectors\u002FCaps Domain - Tego™ for the kidney stratum",[26],"Device: Tego™",{"label":28,"type":10,"description":11,"interventionNames":29},"Securement Domain - Standard of care",[30],"Device: Securement Domain - Standard of Care",{"label":32,"type":16,"description":11,"interventionNames":33},"Securement Domain - SecurAcath®",[34],"Device: SecurAcath®",[36,41,45,49,53,57],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"DEVICE","Connectors\u002FCaps 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.",[9],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"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.",[15],{"type":37,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"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.",[20],{"type":37,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"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.",[24],{"type":37,"name":54,"description":55,"armGroupLabels":56,"otherNames":11},"Securement Domain - Standard of Care","Basic securement using sterile tape\u002Fadhesion fixation device and a simple transparent dressing, without antimicrobial, antiseptic, or engineered stabilization features.",[28],{"type":37,"name":58,"description":59,"armGroupLabels":60,"otherNames":11},"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.",[32],{"type":62,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[64,67,69,71,74,76],{"name":65,"class":66},"Bayside Health","OTHER_GOV",{"name":68,"class":6},"Monash Medical Centre",{"name":70,"class":6},"Princess Alexandra Hospital, Brisbane, Australia",{"name":72,"class":73},"Liverpool Hospital, South Western Sydney Local Health District","UNKNOWN",{"name":75,"class":66},"Royal Brisbane and Women's Hospital",{"name":77,"class":6},"Royal North Shore Hospital","100640666","the-ivcare-adaptive-platform-trial-100640666",false,"NCT07587593","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.","Core inclusion Criteria:\n\n* The patient has or requires a CVAD, including a PICC, a non-tunnelled or tunnelled CVC, or a totally implanted venous access port.\n* Patient is less than 18 years old and paediatric recruitment has not been approved at the site.\n\nSecurement Domain exclusion criteria:\n\n* Central line-associated bloodstream infection (CLABSI) currently suspected associated with any vascular access device (peripheral or central) that is in situ.\n* CLABSI diagnosed from any vascular access device currently in situ within the past 7 days or being actively treated with antimicrobials.\n* Participants with an estimated life expectancy of \\\u003C30 days OR who have commenced a documented end-of-life, terminal-care, or comfort-care pathway.\n* Participants who have previously been randomised for the same CVAD.\n* Participants who have been randomised three times.\n* SecurAcath® cannot be applied in accordance with manufacturer instructions and local policy.\n* 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.\n\nConnectors\u002FCaps Domain exclusion criteria:\n\n* Central line-associated bloodstream infection (CLABSI) currently suspected associated with any vascular access device (peripheral or central) that is in situ.\n* CLABSI diagnosed within the past 14 days or CLABSI being actively treated with antimicrobials, associated with any vascular access device currently in situ.\n* Participants with an estimated life expectancy of \\\u003C30 days OR who have commenced a documented end-of-life, terminal-care, or comfort-care pathway.\n* Participants who have previously been randomised for the same CVAD.\n* Participants who have been randomised three times.\n* Known or suspected hypersensitivity or a confirmed allergy to chlorhexidine or silver-containing products.\n\nCancer stratum inclusion criteria:\n\n* Confirmed diagnosis of a solid tumour OR\n* Confirmed diagnosis of a haematological malignancy. OR\n* Bone marrow failure syndrome requiring systemic therapy, immunosuppression, or haematopoietic stem cell transplantation.\n\nKidney stratum exclusion criteria:\n\n• Confirmed diagnosis of kidney disease.","ALL",{"count":87,"type":88},2500,"ESTIMATED","INTERVENTIONAL",[91],"NA","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.\n\nThe trial starts with two domains. The Connectors\u002FCaps 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\u002Fcaps. In the kidney disease stratum, participants are randomised to receive either ClearGuard™ HD or standard-of-care connectors\u002Fcaps. Following a predefined stopping decision for ClearGuard™ HD in the kidney disease stratum, Tego™ will be introduced and evaluated in this group.\n\nThe 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.",[94,95,96,97],"Device Related Infection","Vascular Access Complication","Device Related Sepsis","Catheter Infection",[99,100,101,102,103,104],"Central venous access device","Chlorhexidine cap","Chlorhexidine connector","Subcutaneous anchor","Central line-associated blood stream infection","Adaptive platform trial","NOT_YET_RECRUITING","2026-05-07",{"date":108,"type":109},"2026-05-14","ACTUAL",{"date":111,"type":88},"2026-12-01",{"date":113,"type":88},"2031-12-01",{"name":5,"class":6}]