[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517070":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":30,"responsibleParty":53,"collaborators":55,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":26,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":26,"overallStatus":33,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"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 Protocols group（CIP group）","EXPERIMENTAL","Preoperative randomization was conducted, followed by a three-day regimen in the week preceding surgery, involving the administration of intravenous iron sucrose at a dosage of 200 mg per day, vitamin C at a dosage of 2 g per day, and subcutaneous administration of Human Erythropoietin Injection at a dosage of 150 IU per kilogram.",[13],"Drug: Iron sucrose, Human Erythropoietin Injection, Vitamin C",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Medical Care group（SMC group）","ACTIVE_COMPARATOR","Standard Medical Care (SMC) for the treatment of IDA. SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).",[19],"Drug: Standard Medical Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Iron sucrose, Human Erythropoietin Injection, Vitamin C","The participants were administered a combined iron supplementation regimen consisting of iron sucrose,Human Erythropoietin Injection, and vitamin C, three times throughout the preoperative week.",[9],null,{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":26},"Standard Medical Care",[15],[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"The Second Affiliated Hospital of Zhejiang University anesthesiology department","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":40,"coordinates":41},"Point",[42,43],120.16142,30.29365,{"lat":43,"lon":42},[46,51],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Min Yan, Doctor","CONTACT","15888210247","zryanmin@zju.edu.cn",{"name":47,"role":52,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[56,58,60,62,64,66,68,70],{"name":57,"class":6},"First Affiliated Hospital of Wenzhou Medical University",{"name":59,"class":6},"Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University",{"name":61,"class":6},"The Central Hospital of Lishui City",{"name":63,"class":6},"First Affiliated Hospital of Chongqing Medical University",{"name":65,"class":6},"Zhejiang Provincial People's Hospital",{"name":67,"class":6},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine",{"name":69,"class":6},"Zhejiang University",{"name":71,"class":6},"Affiliated Hospital of Nanjing University of Chinese Medicine","100517070","the-effect-of-combined-iron-protocols-on-perioperative-allogeneic-transfusion-100517070",false,"NCT06012760","The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion","Effect of Iron Sucrose Combined With Human Erythropoietin and Vitamin C on Perioperative Allogeneic Red Blood Cell Infusion in Major Cardiac Surgery","CIPAT","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",{"count":83,"type":84},400,"ESTIMATED","INTERVENTIONAL",[87],"NA","The goal of this clinical trial is to learn if a combined iron supplementation regimen can reduce the need for blood transfusions in adults with iron-deficiency anemia undergoing major elective cardiac surgery. The trial will also look at whether this regimen is safe and well tolerated. The main questions it aims to answer are:\n\nDoes the combined regimen lower the amount of allogeneic red blood cell transfusion needed during and after surgery?\n\nAre there any side effects or safety concerns associated with the regimen?\n\nResearchers will compare the combined iron supplementation (sucrose iron, erythropoietin, and vitamin C) to standard care to see if it helps reduce blood transfusions.\n\nParticipants will:\n\nReceive either the combined regimen or standard care before surgery\n\nUndergo major elective cardiac surgery under general anesthesia\n\nBe monitored for blood transfusion needs and recovery up to 90 days after surgery",[90,91,92,93,94],"Anemia","Iron Deficiency Anemia","Perioperative","Transfusion","Cardiac Surgery","2026-05-29",{"date":97,"type":98},"2026-06-02","ACTUAL",{"date":100,"type":98},"2025-01-04",{"date":102,"type":84},"2028-03-31",{"name":5,"class":6},1]