[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492965":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":59,"collaborators":61,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":35,"enrollmentInfo":82,"targetDuration":35,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":40,"whyStopped":35,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Individulised transfusion strategy group","EXPERIMENTAL","Patients will recieve red blood cells transfusion in case of a drop of ScVO2 \\\u003C65% after an assessment for the optimisation of SaO2 normalisation (SaO2\\>94%), volume optimisation, ECMO output increase, Fever (body temperature 38°3 C°), Anxiety and Pain",[13],"Drug: Packed Red Blood Cells (PRBCs)",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventionnal transfusion strategy group","ACTIVE_COMPARATOR","Transfusion will be performed in case of a hemoglobin drop \\\u003C9 g\u002FdL",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Packed Red Blood Cells (PRBCs)","Patient will recieve PRBCs transfusion only in case of ScVO2 level\\\u003C65% after assessment of patient for optimisation of SaO2 targeting 100%, volume status, ECMO flow (increase to 20% in relevant), pain, anxiety and fever (body temperature \\>38°3).\n\nIn both groups transfusion may be performed in case massive bleeding according to local protocols, STEMI, Hyperlactatemia \\>4 that can be related to oxygen demand and supply DO2\u002FVO2 ratio impairement, in all groups, transfusion should be performed in case of hemolobin level \\\u003C7g\u002FdL or worsening of neurological condition (Increase in Neurological SOFA component of 1 and more) related to DO2\u002FVO2 impairement.",[15,9],[26],"ScVO2 assesment to guide transfusion",[28],{"name":29,"affiliation":5,"role":30},"Mouhamed MOUSSA, MD","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","0320445962",null,"mouhamed.moussa@chru-lille.fr",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille","RECRUITING","Lille","NORD","59000","France","FR",{"type":47,"coordinates":48},"Point",[49,50],3.05512,50.63391,{"lat":50,"lon":49},[53,56],{"name":54,"role":33,"phone":55,"phoneExt":35,"email":36},"Mouhamed D Moussa, MD","=33659248780",{"name":57,"role":33,"phone":34,"phoneExt":35,"email":58},"Julien Tabareau","julien.tabareau@chru-lille.fr",{"type":60,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[62,64,66,68,70],{"name":63,"class":6},"Amiens University Hospital",{"name":65,"class":6},"University Hospital, Caen",{"name":67,"class":6},"University Hospital, Rouen",{"name":69,"class":6},"Centre Hospitalier Universitaire Dijon",{"name":71,"class":6},"Centre Hospitalier de Lens","100492965","phase-1-individualized-or-conventional-transfusion-strategies-during-peripheral-va-ecmo-100492965",false,"NCT05699005","Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO","Comparison of an Individualized Transfusion Strategy to a Conventional Strategy in Patients Undergoing Peripheral Veno-arterial ECMO for Refractory Cardiogenic Shock: a Randomized Controlled Trial - ICONE","ICONE","Inclusion Criteria:\n\n* Age of 18 and older,\n* supported by peripheral VA-ECMO\n* for cardiogenic shock\n* Life expentency \\>90 days\n* Central venous line available ScVO2 measurement\n\nExclusion Criteria:\n\n* Pregnancy,\n* Lack of health insurance,\n* Opposition to blood transfusion,\n* Known congenital hemoglobin disease or disorder,\n* Metabolic alcaloosis with pH\\>7.8,\n* eCPR,\n* Legally incapacitated adults","ALL","18 Years",{"count":83,"type":84},236,"ESTIMATED","INTERVENTIONAL",[87],"PHASE1","This multicenter randomized controlled trial compare two transfusion strategies of red blood cells transfusion in patients supported by veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock.\n\nAn individualized transfusion strategy based on ScVO2 level, is compared to a conventionnal strategy based on predefined hemoglobin threshold. The primary endpoint is the consumption of packed red blod cells, secondary endpoints are subgroup analysis, mortality, morbidity, and cost-effectiveness",[90,91,92,93,94],"Cardiogenic Shock","Extracorporeal Membrane Oxygenation","Transfusion Related Complication","Anemia","Oxygen Delivery",[96,97,98,99,100,101],"ECMO","ECLS","Refractory cardiogenic shock","Transfusion","ScVO2","Outcome","2026-06-30",{"date":104,"type":105},"2026-07-02","ACTUAL",{"date":107,"type":105},"2023-09-18",{"date":109,"type":84},"2028-12-18",{"name":5,"class":6},1]