[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512961":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":30,"locations":31,"responsibleParty":80,"collaborators":30,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":30,"enrollmentInfo":92,"targetDuration":30,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":34,"whyStopped":30,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Sydney Local Health District","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bivalirudin","ACTIVE_COMPARATOR","Bivalirudin protocol with target activated thromboplastin time (aPTT) of 50-70 seconds",[13],"Drug: Bivalirudin",{"label":15,"type":10,"description":16,"interventionNames":17},"Unfractionated Heparin","Unfractionated heparin protocol with target anti-Xa of 0.3-0.5 IU\u002FmL",[18],"Drug: Unfractionated heparin",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Unfractionated heparin","Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU\u002FmL",[15],[26],"Heparin",{"type":21,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"Bivalirudin protocol with target aPTT 50-70 seconds",[9],null,[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Royal Prince Alfred Hospital","RECRUITING","Sydney","New South Wales","2050","Australia","AU",{"type":41,"coordinates":42},"Point",[43,44],151.20732,-33.86785,{"lat":44,"lon":43},[47,52,55,57,60,62,64,66,68,70,72,74,76,78],{"name":48,"role":49,"phone":50,"phoneExt":30,"email":51},"Timothy J Southwood","CONTACT","+61295156111","timothy.southwood@health.nsw.gov.au",{"name":53,"role":49,"phone":50,"phoneExt":30,"email":54},"Mark Dennis, PhD","mark.dennis@sydney.edu.au",{"name":48,"role":56,"phone":30,"phoneExt":30,"email":30},"PRINCIPAL_INVESTIGATOR",{"name":58,"role":59,"phone":30,"phoneExt":30,"email":30},"Elliot Worku","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":30,"phoneExt":30,"email":30},"Paul Forrest",{"name":63,"role":59,"phone":30,"phoneExt":30,"email":30},"Richard Totaro",{"name":65,"role":59,"phone":30,"phoneExt":30,"email":30},"Lucy Wells",{"name":67,"role":59,"phone":30,"phoneExt":30,"email":30},"Mark Dennis",{"name":69,"role":59,"phone":30,"phoneExt":30,"email":30},"Ru Carey",{"name":71,"role":59,"phone":30,"phoneExt":30,"email":30},"Bruce Cartwright",{"name":73,"role":59,"phone":30,"phoneExt":30,"email":30},"Brian Plunkett",{"name":75,"role":59,"phone":30,"phoneExt":30,"email":30},"Lianne Khoo",{"name":77,"role":59,"phone":30,"phoneExt":30,"email":30},"Anthony Keech",{"name":79,"role":59,"phone":30,"phoneExt":30,"email":30},"Ian Marschner",{"type":81,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100512961","phase-2-bivalirudin-versus-heparin-in-extracorporeal-membrane-oxygenation-100512961",false,"NCT05959252","BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation","BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO)","BLUSH","INCLUSION CRITERIA\n\n* Patients receiving ECMO\n* Age: 18 years or older\n* Ability to randomise the patient within 4 hours of ECMO support initiation\n\nEXCLUSION CRITERIA\n\n* Post-cardiotomy ECMO patients\n* Contraindication to heparin or bivalirudin at time of randomisation e.g., active bleeding\n* Heparin induced thrombotic thrombocytopenia syndrome\n* Where the patient is expected to be disconnected from ECMO in the next day after cannulation.\n* Limitations of care put in place either through patient wishes or the treating medical teams\n* Other reason where the treating physician deems the study is not in the patient's best interest\n* Patients who are suspected or confirmed to be pregnant\n* Inherited bleeding or thrombotic disorders, Systemic Lupus Erythematosus patients","ALL","18 Years",{"count":93,"type":94},80,"ESTIMATED","INTERVENTIONAL",[97],"PHASE2","The goal of this open label randomised clinical trial is to compare Bivalirudin versus Heparin for anticoagulation in patients requiring extracorporeal membrane oxygenation support.\n\nThe main question it aims to answer are include the ability to maintain anticoagulation within defined therapeutic range, bleeding and thrombotic complications and a comparison of the total cost of anticoagulation care.\n\nParticipants will be randomised to either anticoagulation with Bivalirudin or anticoagulation with Unfractionated Heparin.",[100],"Extracorporeal Membrane Oxygenation Complication",[102,9,26,103],"ECMO","Extracorporeal membrane oxygenation","2026-05-07",{"date":106,"type":107},"2026-05-08","ACTUAL",{"date":109,"type":107},"2024-05-01",{"date":111,"type":94},"2026-09-01",{"name":5,"class":6},1]