[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559133":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":215,"collaborators":218,"id":221,"slug":222,"hasResults":223,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":223,"sex":229,"minAge":230,"maxAge":36,"enrollmentInfo":231,"targetDuration":36,"studyType":234,"phases":235,"briefSummary":237,"conditions":238,"keywords":244,"overallStatus":44,"whyStopped":36,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Restrictive strategy","ACTIVE_COMPARATOR","The restrictive strategy will consist of a transfusion Hb threshold of 7.0 g\u002FdL, with a target Hb range of 7.1 - 9.0 g\u002FdL. These thresholds are based on previous non-inferior trials in the patient populations in which VV ECMO (comparable to sepsis) and VA ECMO (cardiac surgery, acute myocardial infarction) are often applied.",[13],"Other: Red Blood Cell transfusion",{"label":15,"type":10,"description":16,"interventionNames":17},"Liberal strategy","The liberal strategy will consist of a transfusion Hb threshold of 9.0 g\u002FdL, with a target Hb range of 9.1 - 11.0 g\u002FdL. These Hb thresholds are based on thresholds that are currently used in ECMO.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Red Blood Cell transfusion","When the appropriate Hb threshold is reached, patients in each group will have one unit of RBC administered at a time. Within 3 hours after the transfusion, a repeat Hb concentration will be measured. Each group will only be transfused when their Hb level falls below the transfusion threshold. In case of a outlier measurement, clinicians are advised to repeat the measurement. The RBC transfusion must take place within 4 hours when the Hb trigger was measured.",[15,9],[24,25,26],"RBC transfusion","pRBCs","packed Red Blood Cells",[28],{"name":29,"affiliation":30,"role":31},"Alexander P.J. Vlaar, PhD","Amsterdam UMC, location AMC","PRINCIPAL_INVESTIGATOR",[33,38],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","020 566 9111",null,"a.p.vlaar@amsterdamumc.nl",{"name":39,"role":34,"phone":35,"phoneExt":36,"email":40},"Stefan F. van Wonderen, MD","s.vanwonderen@amsterdamumc.nl",[42,61,76,85,100,112,127,138,153,169,183,198],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hôpital Erasme Brussels","RECRUITING","Brussels","Brussels Capital","1070","Belgium","BE",{"type":51,"coordinates":52},"Point",[53,54],4.34878,50.85045,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":59,"phoneExt":36,"email":60},"Fabio Taccone, PhD","+32 2 555 31 11","Fabio.Taccone@ulb.be",{"facility":62,"status":44,"city":63,"state":64,"zip":65,"country":48,"countryCode":49,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"KU Leuven, medical IC","Leuven","Flemish Brabant","3000",{"type":51,"coordinates":67},[68,69],4.70093,50.87959,{"lat":69,"lon":68},[72],{"name":73,"role":34,"phone":74,"phoneExt":36,"email":75},"Greet Hermans, PhD","+32 16 33 22 11","greet.hermans@uzleuven.be",{"facility":77,"status":44,"city":63,"state":64,"zip":65,"country":48,"countryCode":49,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"KU Leuven, surgical IC",{"type":51,"coordinates":79},[68,69],{"lat":69,"lon":68},[82],{"name":83,"role":34,"phone":74,"phoneExt":36,"email":84},"Dieter Dauwe, PhD","dieter.dauwe@uzleuven.be",{"facility":86,"status":44,"city":87,"state":88,"zip":89,"country":48,"countryCode":49,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"CHU Charleroi","Charleroi","Hainaut","6000",{"type":51,"coordinates":91},[92,93],4.44448,50.41136,{"lat":93,"lon":92},[96],{"name":97,"role":34,"phone":98,"phoneExt":36,"email":99},"Michaël Piagnerelli, PhD","071 92 11 11","michael.Piagnerelli@ulb.be",{"facility":101,"status":44,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":36,"geoPoint":36,"contacts":107},"Medisch Spectrum Twente (MST)","Enschede","Drenthe","7512 KZ","Netherlands","NL",[108],{"name":109,"role":34,"phone":110,"phoneExt":36,"email":111},"Wytze Vermeijden, PhD","053 487 2000","j.vermeijden@mst.nl",{"facility":113,"status":44,"city":114,"state":115,"zip":116,"country":105,"countryCode":106,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Maastricht Universitair Medisch Centrum+ (MUMC+)","Maastricht","Limburg","6229 HX",{"type":51,"coordinates":118},[119,120],5.68889,50.84833,{"lat":120,"lon":119},[123],{"name":124,"role":34,"phone":125,"phoneExt":36,"email":126},"Marcel van de Poll, PhD","043 387 6543","marcel.vande.poll@mumc.nl",{"facility":30,"status":44,"city":128,"state":129,"zip":130,"country":105,"countryCode":106,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Amsterdam","North Holland","1105 AZ",{"type":51,"coordinates":132},[133,134],4.88969,52.37403,{"lat":134,"lon":133},[137],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},{"facility":139,"status":44,"city":140,"state":141,"zip":142,"country":105,"countryCode":106,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Universitair Medisch Centrum Groningen (UMCG)","Groningen","Provincie Groningen","9713 GZ",{"type":51,"coordinates":144},[145,146],6.56667,53.21917,{"lat":146,"lon":145},[149],{"name":150,"role":34,"phone":151,"phoneExt":36,"email":152},"Walter van den Bergh, PhD","050 361 6161","w.m.van.den.bergh@umcg.nl",{"facility":154,"status":155,"city":156,"state":157,"zip":158,"country":105,"countryCode":106,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Leids Universitair Medisch Centrum (LUMC)","NOT_YET_RECRUITING","Leiden","South Holland","2333 ZA",{"type":51,"coordinates":160},[161,162],4.49306,52.15833,{"lat":162,"lon":161},[165],{"name":166,"role":34,"phone":167,"phoneExt":36,"email":168},"Carlos Elzo Kraemer, MD","071 526 9111","c.v.elzo_kraemer@lumc.nl",{"facility":170,"status":155,"city":171,"state":157,"zip":172,"country":105,"countryCode":106,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Erasmus MC","Rotterdam","3015 GD",{"type":51,"coordinates":174},[175,176],4.47917,51.9225,{"lat":176,"lon":175},[179],{"name":180,"role":34,"phone":181,"phoneExt":36,"email":182},"Christiaan Meuwese, PhD","010 704 0704","c.meuwese@erasmusmc.nl",{"facility":184,"status":44,"city":185,"state":186,"zip":187,"country":105,"countryCode":106,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"St. Antonius Ziekenhuis","Nieuwegein","Utrecht","3435 CM",{"type":51,"coordinates":189},[190,191],5.08056,52.02917,{"lat":191,"lon":190},[194],{"name":195,"role":34,"phone":196,"phoneExt":36,"email":197},"Erik Scholten, MD","088 320 3000","e.scholten@antoniusziekenhuis.nl",{"facility":199,"status":155,"city":200,"state":201,"zip":202,"country":203,"countryCode":204,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Karolinska Universtiy Hospital","Stockholm","Stockholm County","171 76","Sweden","SE",{"type":51,"coordinates":206},[207,208],18.06871,59.32938,{"lat":208,"lon":207},[211],{"name":212,"role":34,"phone":213,"phoneExt":36,"email":214},"Lars M. Broman, PhD","+46 8 123 70 000","lars.broman@regionstockholm.se",{"type":31,"investigatorFullName":216,"investigatorTitle":217,"investigatorAffiliation":30,"oldNameTitle":36,"oldOrganization":36},"A.P.J. Vlaar","Prof. Dr.",[219],{"name":220,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development","100559133","restrictive-versus-liberal-thresholds-for-rbc-transfusion-in-ecmo-100559133",false,"NCT06560164","Restrictive Versus Liberal Thresholds for RBC Transfusion in ECMO","Restrictive Versus Liberal Thresholds for Red Blood Cell Transfusion in ExtraCorporeal Membrane Oxygenation - the TREC Study","TREC","Inclusion Criteria:\n\n* Patient is aged 18 years or older;\n* Is receiving ECMO;\n* (Deferred) informed consent.\n\nExclusion Criteria:\n\n* Not expected to survive for 24 hours when assessed;\n* Inability to receive blood products;\n* (Known) decline to blood transfusions (e.g., Jehovah's Witnesses);\n* Extracorporeal carbon dioxide removal (ECCO2R) using low blood flow devices or pumpless devices (i.e., MINILUNG ®, PrismaLung+);\n* Received ECMO over 48h before screening for eligibility.","ALL","18 Years",{"count":232,"type":233},526,"ESTIMATED","INTERVENTIONAL",[236],"NA","Rationale: In patients supported with extracorporeal membrane oxygenation (ECMO), transfusion of red blood cells (RBC) is very common. This is possibly due to the application of liberal thresholds and the lack of evidence-based guidelines. Although RBC transfusion can be lifesaving, it is also a risk-bearing intervention with substantial risk for morbidity and mortality in this critically ill population. Also, with increasing scarcity, RBC transfusions are becoming more expensive. Furthermore, in the past decades it has been shown in several critically ill patient populations - not on ECMO - that maintaining a restrictive hemoglobin (Hb) threshold for RBC transfusion is non-inferior, including in cardiothoracic surgery, acute myocardial infarction and septic shock. Therefore, the investigators hypothesize that a restrictive transfusion threshold for RBC is safe to apply in patients on ECMO in comparison with a liberal transfusion threshold.\n\nObjective: The primary objective of this trial is to study in a prospective randomized comparison whether a restrictive RBC transfusions strategy is non-inferior compared to a liberal strategy in patients on ECMO with respect to 90-day mortality.\n\nStudy design: Prospective multi-center randomized controlled non-inferiority trial.\n\nStudy population: Patients, 18 years or older, receiving ECMO.\n\nIntervention: Restrictive RBC transfusion threshold: in case the Hb transfusion trigger of 7.0 g\u002FdL (4.3 mmol\u002FL) is reached, 1 RBC unit at a time will be transfused. The aimed Hb target range of the restrictive\u002Fintervention group will be 7.1 - 9.0 g\u002FdL (4.3 - 5.6 mmol\u002FL). Liberal RBC transfusion threshold: in case the Hb transfusion trigger of 9.0 g\u002FdL (5.6 mmol\u002FL) is reached, 1 RBC unit at a time will be transfused. Target range of the liberal group is defined as Hb 9.1 - 11.0 g\u002FdL\n\nMain study parameters\u002Fendpoints: The primary outcome parameter is 90-day all-cause mortality.\n\nSecondary outcomes include: 1) proportion of patients on ECMO exposed to allogeneic RBC transfusion; 2) RBC volume infused per patient during ECMO; 3) reasons for RBC transfusion other than Hb triggers; 4) transfusion reactions; 5) time on ECMO; 6) length of hospital- and ICU-stay; 7) in-ICU morbidity; 8) quality of life (QoL), iMTA Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ) at 3, 6, 9, and 12 months; 9) costs related to a) transfusion, b) hospital admission and c) transfusion-related sequelae.",[239,240,241,242,243],"Transfusion","Red Blood Cell","Extracorporeal Membrane Oxygenation","Anemia","ECMO",[239,240,241,242,243],"2025-04-04",{"date":247,"type":248},"2025-04-08","ACTUAL",{"date":250,"type":248},"2024-11-26",{"date":252,"type":233},"2029-10-01",{"name":5,"class":6},12]