[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sydney Local Health District\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Extracorporeal Membrane Oxygenation Complication",[29,30,31,32],"ECMO","Bivalirudin","Heparin","Extracorporeal membrane oxygenation","RECRUITING","2026-05-07",{"date":36,"type":37},"2026-05-08","ACTUAL",{"date":39,"type":37},"2024-05-01",{"date":41,"type":21},"2026-09-01",{"name":43,"class":44},"Sydney Local Health District","OTHER_GOV",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100560539","end-tidal-oxygen-for-intubation-in-the-emergency-department-100560539","NCT06578468","End-Tidal Oxygen for Intubation in the Emergency Department","Preoxygenation Using End-Tidal Oxygen for Rapid Sequence Intubation in the Emergency Department (The PREOXED Trial) - a Multicentre Stepped Wedge Cluster Randomised Control Trial","PREOXED","Inclusion Criteria:\n\n1. The patient is located in the ED resuscitation bay of the participating centre.\n2. The planned procedure is orotracheal intubation using a laryngoscope and RSI technique with preoxygenation for patients who are spontaneously breathing.\n3. The patient is deemed to be at a high risk of hypoxia during RSI as per the treating ED clinician, as defined by:\n\n   * Any patient requiring any form of oxygen therapy before preoxygenation.\n   * Any patient with respiratory pathology based on clinical or radiological findings. Including, but not limited to:\n\n     * Pneumonia, pulmonary oedema, acute respiratory distress syndrome (ARDS), aspiration, pulmonary contusion from trauma, infective exacerbations of known lung disease (e.g. asthma, pulmonary fibrosis, emphysema) or pulmonary embolism (PE)\n   * Any patient with high oxygen consumption. Including, but not limited to:\n\n     * Sepsis, Diabetic ketoacidosis, alcohol or drug withdrawal, seizures, thyrotoxicosis\n   * Any underlying patient condition that may predispose to hypoxemia. Including, but not limited to:\n\n     * Obesity, pregnancy, underlying lung disease (e.g. asthma, pulmonary fibrosis, emphysema), severe injury- hypovolaemia\u002Fhaemorrhage.\n   * or any other patient that the treating clinician has a high concern for hypoxemia during RSI.\n\nExclusion Criteria:\n\n1. Patient is known to be less than 18 years old.\n2. The patient has a supraglottic device in-situ e.g iGel or LMA.\n3. The patient is known to be pregnant.\n4. The patient is known to be a prisoner.\n5. The patient was intubated in the prehospital environment.\n6. Immediate need for tracheal intubation precludes preoxygenation i.e. the patient is in cardiac arrest.",{"count":55,"type":21},1400,[57],"NA","Rapid Sequence Intubation (RSI) is a high-risk procedure in the emergency department (ED). Patients are routinely preoxygenated (given supplemental oxygen) prior to RSI to prevent hypoxia during intubation. For many years anaesthetists have used end-tidal oxygen (ETO2) levels to guide the effectiveness of preoxygenation prior to intubation. The ETO2 gives an objective measurement of preoxygenation efficacy. This is currently not available in most EDs.\n\nThis trial evaluates the use of ETO2 on the rate of hypoxia during intubation for patients in the ED.",[60,61,62],"Critical Illness","Hypoxia","Respiratory Failure",[64],"Emergency Intubation","2024-09-04",{"date":67,"type":37},"2024-09-19",{"date":69,"type":37},"2024-08-05",{"date":71,"type":21},"2025-12-31",{"name":43,"class":44},9,""]