[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590555":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":59,"collaborators":61,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":32,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":32,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":32,"overallStatus":42,"whyStopped":32,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Combined Iron Supplementation Group","EXPERIMENTAL","Patients in the experimental group will receive a combination therapy consisting of intravenous sucrose iron (200 mg), subcutaneous recombinant human erythropoietin (150 IU\u002Fkg), and intravenous vitamin C (2 g), administered once daily for three consecutive days within the week prior to surgery. All perioperative transfusion decisions will follow standardized restrictive transfusion thresholds",[13],"Drug: Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional treatment group","ACTIVE_COMPARATOR","Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices",[19],"Procedure: Routine perioperative management",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C","Patients in the experimental group will receive a combination therapy consisting of intravenous sucrose iron (200 mg), subcutaneous recombinant human erythropoietin (150 IU\u002Fkg), and intravenous vitamin C (2 g), administered once daily for three consecutive days within the week prior to surgery.",[9],[27],"Routine perioperative management",{"type":29,"name":27,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices.",[15],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Qi Gao, Dr.","CONTACT","19857136919","gaoqi19950203@163.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","330100","China","CN",{"type":49,"coordinates":50},"Point",[51,52],120.16142,30.29365,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":57,"phoneExt":32,"email":58},"Min Yan","+861375711863","zryanmin@zju.edu.cn",{"type":60,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[62,64,66,68,70],{"name":63,"class":6},"First Affiliated Hospital of Chongqing Medical University",{"name":65,"class":6},"Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University",{"name":67,"class":6},"The First Affiliated Hospital with Nanjing Medical University",{"name":69,"class":6},"First Affiliated Hospital of Wenzhou Medical University",{"name":71,"class":6},"Zhejiang Provincial People's Hospital","100590555","long-term-outcomes-sub-study-of-preoperative-combined-iron-therapy-100590555",false,"NCT06968936","Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy","Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy in Anemic Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Participants must be at least 18 years of age.\n2. Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both.\n3. Iron deficiency anemia is defined as having a ferritin level below 100 μg\u002FL or a ferritin level below 300 μg\u002FL accompanied by a transferrin saturation below 25%. Additionally, hemoglobin levels should range between 90 and 130 g\u002FL for men or between 90 and 120 g\u002FL for women.\n4. The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3.\n5. Prior to participation, the patient or their legal representative must provide informed consent.\n\nExclusion Criteria:\n\n1. Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO.\n2. Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics.\n3. Individuals with a weight equal to or less than 50kg.\n4. Individuals with a family history of haemochromatosis or thalassaemia, or those with a transferrin saturation level exceeding 50% or a documented history of iron overload.\n5. Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc.\n6. Requirement for emergency surgical intervention.\n7. Severe hepatic or renal impairment, ALT \\>3 times the upper limit of normal value or AST \\>3 times the upper limit of normal value, creatinine \\>1.5 times the upper limit of normal value\n8. Pregnant or lactating women\n9. history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeks prior to surgery\n10. Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.","ALL","18 Years","85 Years",{"count":83,"type":84},400,"ESTIMATED","INTERVENTIONAL",[87],"NA","This is a sub-study of the Preoperative Combined Iron Therapy trail in which some participants will be additionally randomized to combined iron supplementation or standarded treatment control to evaluate the impact on long-term outcomes.",[90,91,92],"Anemia","Iron Deficiencies","Cardiac Surgery","2026-04-07",{"date":95,"type":96},"2026-04-13","ACTUAL",{"date":98,"type":96},"2026-03-27",{"date":100,"type":84},"2029-06-30",{"name":5,"class":6},1]