[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557767":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":23,"locations":35,"responsibleParty":59,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":23,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":23,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":23,"overallStatus":38,"whyStopped":23,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Federal University of São Paulo","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Randomized Anemia Group for non-PBM protocol (GNPBM)","EXPERIMENTAL","Patients \\> 18 years admitted to Hospital São Paulo for Coronary Artery Bypass Grafting (CABG) surgery who are hospitalized in the Cardiovascular Surgery department or another specialty unit and are anemic (Hemoglobin - Hb \\\u003C 12g\u002Fdl in women and \\\u003C 13g\u002Fdl in men)",[13],"Procedure: blood transfusion",{"label":15,"type":10,"description":16,"interventionNames":17},"Randomized Anemia Group for PBM protocol (GPBM)","Patients \\>18 years admitted to Hospital São Paulo for Coronary Artery Bypass Grafting (CABG) surgery who are hospitalized in the Cardiovascular Surgery department or another specialty unit and are anemic (Hb \\\u003C 12g\u002Fdl in women and \\\u003C 13g\u002Fdl in men)",[18],"Drug: Erythropoietin",{"label":20,"type":21,"description":22,"interventionNames":23},"Control Group (GC)","NO_INTERVENTION","Patients \\> 18 years admitted to Hospital SãoPaulo for Coronary Artery Bypass Grafting (CABG) surgery who arehospitalized in the Cardiovascular Surgery department or another specialty unit and do not have anemia (Hb \\> 13g\u002Fdl in men and \\> 12g\u002Fdl in women)",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DRUG","Erythropoietin","* Treatment regimen for hospitalized patients awaiting non-urgent surgeries: Administer EPO 600 IU\u002Fkg\u002Fweek via subcutaneous (SC) or intravenous (IV) route, followed by 300 IU\u002Fkg\u002Fday via SC or IV 10 days before surgery. If ferritin \\\u003C 100 ng\u002FdL, supplement with IV iron (Iron hydroxide up to 600 mg\u002Fweek or Ferric carboxymaltose up to 1000 mg\u002Fweek).\n* Treatment regimen for hospitalized patients awaiting non-urgent surgeries with less than 5 days until surgery: Administer 40000 UI of EPO intravenous (IV) attack and supplement with IV iron (Iron hydroxide up to 600 mg\u002Fweek or Ferric carboxymaltose up to 2000 mg\u002Fweek), then 300UI\u002FKg\u002Fday IV or SC of EPO until day of surgery.",[15],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":23},"PROCEDURE","blood transfusion","After surgery, this group will receive one unit of RBC at the moment of ICU admission.\n\nHb \\> 8 g\u002Fdl: 1 unit of RBC. HB \\\u003C 8 g\u002Fdl: 2 units of RBC.",[9],[36],{"facility":37,"status":38,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Leonardo Ohashi","RECRUITING","São Paulo","04024-002","Brazil","BR",{"type":44,"coordinates":45},"Point",[46,47],-46.63611,-23.5475,{"lat":47,"lon":46},[50,55],{"name":51,"role":52,"phone":53,"phoneExt":23,"email":54},"ISABEL CESPEDES, PhD","CONTACT","05511996895763","isabel.cespedes@unifesp.br",{"name":56,"role":52,"phone":57,"phoneExt":23,"email":58},"LEONARDO OHASHI, MD","05511970531919","leonardo.ohashi@unifesp.br",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","LEONARDO OHASHI","MD",[64],{"name":65,"class":66},"Fundação de Amparo à Pesquisa do Estado de São Paulo","OTHER_GOV","100557767","phase-2-pbm-as-strategy-to-cabg-anemic-patients-bypass-graft-cabg-100557767",false,"NCT06542393","PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)","Patient Blood Manegement (PBM) as Perioperative Strategy to Anemic Patients Who Will be Submitted to Coronary Artery Bypass Graft (CABG).","Inclusion Criteria:\n\n* Eletive surgery;\n* Only CABG as procedure;\n* Off pump CABG candidate.\n\nExclusion Criteria:\n\n* Age \\> 80 years;\n* Chronic dialytic kidney disease;\n* Chronic rheumatologic disease;\n* Men with Hb levels \\> 13 g\u002Fdl and \\\u003C 8g\u002Fdl;\n* Women with Hb levels \\> 12 g\u002Fdl and \\\u003C 8g\u002Fdl;\n* Presence of another heart disease requiring surgical intervention;\n* Presence of hepatic insufficiency;\n* Presence of any implantable electronic cardiac device in any cardiac chambers;\n* Pregnancy;\n* Diagnosis of malignant neoplasia;\n* Thrombophilias;\n* Need for Erythropoietin treatment due to any other disease.\n* Recent ischemic event (\\\u003C 3 months).\n* Ejection fraction \\\u003C30%.",true,"ALL","18 Years","80 Years",{"count":79,"type":80},120,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","Anemia poses risks during coronary artery bypass grafting (CABG), increasing complications and mortality rates. Blood transfusions in cardiac surgery have negative outcomes, prompting the use of erythropoietin in Patient Blood Management (PBM) to limit transfusion needs and enhance postoperative recovery. EPO can reduce blood component requirements, adverse events, and inflammation in anemic CABG patients. A study aims to minimize transfusions through a PBM anemia treatment protocol for CABG patients, comparing outcomes in three groups: a Control Group (CG), a Non-PBM Group (NPBMG) treated with blood components, and a PBM Group (GPBM) treated with EPO. Parameters include post-op stay, mortality, cardiovascular events, non-cardiovascular events, ICU time, mechanical ventilation duration, vasoactive drug use, inflammatory responses, and cardiac cell death. Analysis will consider demographic and clinical factors, with expectations that GPBM will yield superior results compared to NPBMG and similar or better outcomes than CG.",[86,87,88,89,90,91,92,93],"Anemia","Coronary Disease","Coronary Artery Disease","Coronary Stenosis","Coronary Occlusion","Systemic Inflammatory Response","Bleeding","Epigenetic Disorder","2024-08-04",{"date":96,"type":97},"2024-08-07","ACTUAL",{"date":99,"type":97},"2024-06-01",{"date":101,"type":80},"2026-06-01",{"name":5,"class":6},1]