[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515793":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":172,"collaborators":174,"id":193,"slug":194,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":195,"sex":201,"minAge":202,"maxAge":24,"enrollmentInfo":203,"targetDuration":24,"studyType":206,"phases":207,"briefSummary":209,"conditions":210,"keywords":215,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"fullName":5,"class":6},"University of Leicester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypothermic Cardiopulmonary Bypass","ACTIVE_COMPARATOR","Patients allocated to this arm will undergo standard care for coronary artery bypass grafting and\u002For valve surgery with mild hypothermia during CPB.",[13],"Procedure: Hypothermic Cardiopulmonary Bypass",{"label":15,"type":10,"description":16,"interventionNames":17},"Normothermic Cardiopulmonary Bypass","Patients allocated to this arm will undergo intervention care for coronary artery bypass grafting and\u002For valve surgery with normothermia hypothermia during CPB.",[18],"Procedure: Normothermic Cardiopulmonary Bypass",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Mild hypothermia (between 32 - 35 °C) during cardiopulmonary bypass",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Normothermia (active maintenance of temperature between 36.5 °C to 37.5°C; no active cooling below 36.5 °C) during cardiopulmonary bypass",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Gavin J Murphy, FRCS, MD, MBChB, BSc","CONTACT","0116 258 3054","gjm19@le.ac.uk",{"name":35,"role":31,"phone":24,"phoneExt":24,"email":36},"Ann Cheng, MBChB, MSc","ann.cheng1@nhs.net",[38,55,69,82,95,104,117,127,133,146,159],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Glenfield Hospital, University Hospitals of Leicester NHS Trust","RECRUITING","Leicester","Leicestershire","LE3 9QP","United Kingdom","UK",{"type":47,"coordinates":48},"Point",[49,50],-1.13169,52.6386,{"lat":50,"lon":49},[53],{"name":54,"role":31,"phone":24,"phoneExt":24,"email":36},"Ann Cheng",{"facility":56,"status":57,"city":58,"state":24,"zip":59,"country":44,"countryCode":45,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust","NOT_YET_RECRUITING","Blackpool","FY3 8NR",{"type":47,"coordinates":61},[62,63],-3.05,53.81667,{"lat":63,"lon":62},[66],{"name":67,"role":31,"phone":24,"phoneExt":24,"email":68},"Marcus Taylor","marcus.taylor1@nhs.net",{"facility":70,"status":40,"city":71,"state":24,"zip":72,"country":44,"countryCode":45,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"University Hospitals Bristol and Weston NHS Foundation Trust","Bristol","BS1 3NU",{"type":47,"coordinates":74},[75,76],-2.59665,51.45523,{"lat":76,"lon":75},[79],{"name":80,"role":31,"phone":24,"phoneExt":24,"email":81},"Luke Rogers","ljrogers@doctors.org.uk",{"facility":83,"status":40,"city":84,"state":24,"zip":85,"country":44,"countryCode":45,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust","Cottingham","HU16 5JQ",{"type":47,"coordinates":87},[88,89],-0.7554,52.50243,{"lat":89,"lon":88},[92],{"name":93,"role":31,"phone":24,"phoneExt":24,"email":94},"Mohamed Sherif","mohamed.sherif3@nhs.net",{"facility":96,"status":40,"city":97,"state":24,"zip":98,"country":44,"countryCode":45,"cosmosGeoPoint":99,"geoPoint":103,"contacts":24},"Golden Jubilee National Hospital, NHS Golden Jubilee","Glasgow","G81 4DY",{"type":47,"coordinates":100},[101,102],-4.25763,55.86515,{"lat":102,"lon":101},{"facility":105,"status":40,"city":106,"state":24,"zip":107,"country":44,"countryCode":45,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"King's College Hospital, King's College Hospital NHS Foundation Trust","London","SE5 9RS",{"type":47,"coordinates":109},[110,111],-0.12574,51.50853,{"lat":111,"lon":110},[114],{"name":115,"role":31,"phone":24,"phoneExt":24,"email":116},"Naomi Watson","naomi.watson5@nhs.net",{"facility":118,"status":57,"city":106,"state":24,"zip":119,"country":44,"countryCode":45,"cosmosGeoPoint":120,"geoPoint":122,"contacts":123},"Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust","SW3 6NP",{"type":47,"coordinates":121},[110,111],{"lat":111,"lon":110},[124],{"name":125,"role":31,"phone":24,"phoneExt":24,"email":126},"Ricky Vaja","r.vaja@rbht.nhs.uk",{"facility":128,"status":57,"city":106,"state":24,"zip":129,"country":44,"countryCode":45,"cosmosGeoPoint":130,"geoPoint":132,"contacts":24},"Harefield Hospital, Guy's and St Thomas' NHS Foundation Trust","UB9 6JH",{"type":47,"coordinates":131},[110,111],{"lat":111,"lon":110},{"facility":134,"status":40,"city":135,"state":24,"zip":136,"country":44,"countryCode":45,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust","Oxford","OX3 9DU",{"type":47,"coordinates":138},[139,140],-1.25596,51.75222,{"lat":140,"lon":139},[143],{"name":144,"role":31,"phone":24,"phoneExt":24,"email":145},"Ali Ansaripour","ali.ansaripou@ouh.nhs.uk",{"facility":147,"status":40,"city":148,"state":24,"zip":149,"country":44,"countryCode":45,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Derriford Hospital, Plymouth University Hospitals NHS Trust","Plymouth","PL6 8DH",{"type":47,"coordinates":151},[152,153],-4.14305,50.37153,{"lat":153,"lon":152},[156],{"name":157,"role":31,"phone":24,"phoneExt":24,"email":158},"Omar Zibdeh","o.zibdeh@nhs.net",{"facility":160,"status":40,"city":161,"state":24,"zip":162,"country":44,"countryCode":45,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust","Sheffield","S5 7AU",{"type":47,"coordinates":164},[165,166],-1.4659,53.38297,{"lat":166,"lon":165},[169],{"name":170,"role":31,"phone":24,"phoneExt":24,"email":171},"Olaniran Omodara","olaniran.omodara@nhs.net",{"type":173,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[175,177,179,181,184,185,187,189,191],{"name":176,"class":6},"NHS National Waiting Times Centre Board",{"name":178,"class":6},"Sheffield Teaching Hospitals NHS Foundation Trust",{"name":180,"class":6},"Oxford University Hospitals NHS Trust",{"name":182,"class":183},"Hull University Teaching Hospitals NHS Trust","OTHER_GOV",{"name":70,"class":6},{"name":186,"class":6},"University Hospitals, Leicester",{"name":188,"class":6},"Royal Brompton & Harefield NHS Foundation Trust",{"name":190,"class":6},"King's College Hospital NHS Trust",{"name":192,"class":6},"University Hospital Plymouth NHS Trust","100515793","study-on-optimal-temperature-during-cardiopulmonary-bypass-thermic-4-100515793",false,"NCT05996120","Study on Optimal Temperature During Cardiopulmonary Bypass (THERMIC-4)","Normothermic Versus Hypothermic Cardiopulmonary Bypass in Adult Cardiac Surgery: a Multicentre Feasibility Randomised Controlled Trial","THERMIC-4","INCLUSION CRITERIA\n\nParticipants may enter the trial if all of the following apply\n\n1. Adult patients (≥ 18 years) scheduled for coronary artery bypass surgery and\u002For valve replacement\u002F repair, either in the elective or urgent setting.\n2. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of 2 or higher.\n3. Able to understand and communicate to provide informed consent.\n4. Able to read and understand the English language.\n\nEXCLUSION CRITERIA\n\nParticipants may not enter the trial if any of the following apply:\n\n1. Patients undergoing coronary artery bypass surgery in combination with other procedures including cardiac or vascular procedures that require deep hypothermic arrest.\n2. Patients undergoing emergency or salvage surgery.\n3. Patients undergoing off-pump cardiac surgery.\n4. Patients who are participating in another interventional trial.\n5. Unable to provide informed consent.","ALL","18 Years",{"count":204,"type":205},100,"ESTIMATED","INTERVENTIONAL",[208],"NA","In order to perform heart surgery, a machine called cardiopulmonary bypass (CPB), or more commonly known as a heart-lung machine, is used to maintain the circulation of oxygenated blood needed by the rest of the body and its organs.\n\nHistorically, when a patient is connected to CPB, their body is cooled below the normal body temperature. This is known as hypothermia. This is because scientific studies have previously shown that reduced body temperature lowers metabolism and therefore offers more protection to the brain and other organs due to the reduced oxygen requirement. The evidence supporting this practice, however, has been challenged throughout the history of cardiac surgery, with studies supporting that normothermia, or normal body temperature, is a safe alternative. Despite this, the practice of hypothermia has persisted. Published data from a survey of 139 cardiac surgeons in the United Kingdom showed that 84% still routinely employ hypothermic CPB during surgery.\n\nTo assess whether normothermic or hypothermic CPB is safer, a clinical trial requiring a large sample size and high recruitment rates will be required. Therefore, the investigators aim to assess firstly the feasibility of trial recruitment and allocation adherence in this study. 100 adults across 10 different cardiac surgery centres in the United Kingdom will be recruited to a multicentre feasibility randomised controlled trial comparing normothermia (active comparator) against hypothermia (control comparator) during cardiopulmonary bypass in cardiac surgery. This study will also test the ability of the Cardiothoracic Interdisciplinary Research Network (CIRN), a trainee-led research collaborative, to collect pilot data on Major Adverse Cardiac and Cerebrovascular Events (MACCE) using a regulation-approved electronic application HealthBitⓇ. Participants will also be asked to complete quality of life surveys. The results of this study will subsequently inform a large, adequately powered randomised controlled trial for optimal temperature management during CPB.",[211,212,213,214],"Ischemic Heart Disease","Valvular Heart Disease","Cardiovascular Diseases","Surgery-Complications",[216,217,218,219],"cardiopulmonary bypass","hypothermia","myocardial protection","neurologic protection","2025-03-31",{"date":222,"type":223},"2025-04-03","ACTUAL",{"date":225,"type":223},"2024-05-20",{"date":227,"type":205},"2026-02",{"name":5,"class":6},11]