[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"red-blood-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:red-blood-cell":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":32,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},526,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31],"Transfusion","Red Blood Cell","Extracorporeal Membrane Oxygenation","Anemia","ECMO",[27,28,29,30,31],"RECRUITING","2025-04-04",{"date":36,"type":37},"2025-04-08","ACTUAL",{"date":39,"type":37},"2024-11-26",{"date":41,"type":21},"2029-10-01",{"name":43,"class":44},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",12]