[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571975":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":33,"locations":39,"responsibleParty":69,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":18,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":18,"enrollmentInfo":84,"targetDuration":18,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":18,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Interlinked AB","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ReLink®","EXPERIMENTAL","One or more investigational devices will be added to the infusion line. Standard practise procedure related to PIVC infusions according to hospital norm will be followed. Thereafter the planned IV therapy is initiated until completion.",[13],"Device: Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Standard practise related to PIVC infusions according to hospital norm will be followed. Thereafter the planned IV therapy is initiated until completion.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Intervention","The interventional device is a coupling device intended to prevent mechanical complications during peripheral intravenous infusions. While control will not receive the device.",[9],[26,30],{"name":27,"affiliation":28,"role":29},"Ramon Mir Abellán, PhD","Parc Sanitari Sant Joan de Déu","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":29},"António Manuel Marques, PhD","Unidade Local de Saúde de Coimbra, EPE",[34],{"name":35,"role":36,"phone":37,"phoneExt":18,"email":38},"Christopher Blacker, Medical Doctor","CONTACT","+46737301399","christopher.blacker@uu.com",[40,58],{"facility":41,"status":42,"city":43,"state":18,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Centro Hospitalar e Universitário de Coimbra","RECRUITING","Coimbra","3000-075","Portugal","PT",{"type":48,"coordinates":49},"Point",[50,51],-8.41996,40.20686,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":18,"email":57},"PI","+351 239 400 400","amarques@chuc.min-saude.pt",{"facility":28,"status":59,"city":60,"state":18,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":18},"COMPLETED","Barcelona","08830","Spain","ES",{"type":48,"coordinates":65},[66,67],2.15899,41.38879,{"lat":67,"lon":66},{"type":70,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[72,74],{"name":28,"class":73},"OTHER",{"name":32,"class":73},"100571975","safe-infusion-study-100571975",false,"NCT06727240","Safe-Infusion Study","A Non-Inferiority Randomized Clinical Trial Investigating Efficacy and Safety of an Innovative Medical Device in the Reduction of Mechanical Complications of Peripheral Intravenous Catheters","Inclusion Criteria:\n\n* The patient has or will get a vascular access device (VAD) expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion ≥2h and intermitted as an infusion lasting 15min to \\\u003C2h.\n* ≥18 years of age\n* Speak and understand local language\n* VADs already in place when the patient is admitted to the ward should not present with phlebitis or infiltration or occlusion\n* Participants have signed the informed consent or have a legal authorized representative (LAR) who has provided this consent\n\nExclusion Criteria:\n\n* The VAD is expected to be used for sampling only\n* Pregnancy\n* Unable to obtain informed consent or without an available LAR to provide surrogate informed consent\n* Patients under palliative care\n* Bolus IV infusion, defined as an infusion time of \\\u003C15 min","ALL","18 Years",{"count":85,"type":86},548,"ESTIMATED","INTERVENTIONAL",[89],"NA","Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or dislodgement. These complications can collectively be named mechanical complications. This study aims to assess a new device's effectiveness in reducing mechanical complications associated with PIVCs through a non-inferiority randomized trial at two sites. A total of 548 patients will be recruited, with primary outcomes focused on complication rates and secondary outcomes examining adverse events, healthcare feedback, and economic impacts.",[92,93],"Intravenous Access","Medical Device","2024-12-11",{"date":96,"type":97},"2024-12-16","ACTUAL",{"date":99,"type":97},"2024-03-25",{"date":101,"type":86},"2025-03",{"name":5,"class":6},2]