[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466408":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Iron treatment intervention arm","EXPERIMENTAL","The combination therapy group will receive three treatments consisting of 200 mg\u002F100 ml of iron sucrose IV infusion, 150 IU\u002FKg of erythropoietin subcutaneously and 2 mg\u002F100 ml of vitamin C IV infusion in the week prior to surgery",[13],"Drug: Iron Sucrose, recombinant human erythropoietin, ascorbic acid",{"label":15,"type":16,"description":17,"interventionNames":18},"conventional treatment arm","ACTIVE_COMPARATOR","Treatment in accordance with measures routinely used by the surgeon's team to treat anemia including but not limited to (clinical observation, oral iron supplementation, intravenous iron supplementation, blood transfusion, or other measures) will be documented faithfully by the study team",[19],"Procedure: conventional treatment",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Iron Sucrose, recombinant human erythropoietin, ascorbic acid","During the 1 week period following admission, 3 consecutive dosing regimens were administered, 200 mg of iron sucrose by intravenous infusion at 8am daily in combination with 150 IU\u002Fkg of recombinant human erythropoietin by subcutaneous injection and 2 g of ascorbic acid by intravenous infusion.",[9],null,{"type":28,"name":29,"description":17,"armGroupLabels":30,"otherNames":26},"PROCEDURE","conventional treatment",[15],[32],{"name":33,"affiliation":34,"role":35},"Min Yan, Doctor","2nd Affiliated Hospital, School of Medicine, Zhejiang University, China","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Min Yan","CONTACT","13757118632","zryanmin@zju.edu.cn",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"The Second Affiliated Hospital of Zhejiang University Medical College","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":52,"coordinates":53},"Point",[54,55],120.16142,30.29365,{"lat":55,"lon":54},[58],{"name":33,"role":39,"phone":59,"phoneExt":26,"email":41},"15888210247",{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100466408","effect-of-the-combined-programme-on-perioperative-anaemiacppa-100466408",false,"NCT05353348","Effect of the Combined Programme on Perioperative Anaemia（CPPA）","Effectiveness of Iron Sucrose Combined With rHuEPO and Ascorbic Acid in Improving Perioperative Anaemia in Patients Undergoing Major Cardiac Surgery","Inclusion Criteria:\n\n* Age 18 years and above\n* Ferritin \\\u003C300µg\u002FL, transferrin saturation \\\u003C25%, male 90\\\u003CHb\\\u003C130g\u002FL or female 90\\\u003CHb\\\u003C120g\u002FL\n* Elective major cardiac surgery (valve replacement, CABG coronary artery bypass surgery or a combination of both)\n* ASA: Grade 1-3\n* Signed informed consent\n\nExclusion Criteria:\n\n1. Allergy or contraindication to iron sucrose or recombinant human erythropoietin or ascorbic acid\n2. Patients with a preoperative temperature \\>37.5 °C or on non-prophylactic antibiotics\n3. Pregnancy or breastfeeding stage\n4. weight ≤ 50 kg\n5. Presence of chronic renal insufficiency, urinary stones, oxalate deposits, gout\n6. Chronic liver disease and\u002For screening alanine transferase\u002Faspartate transferase above normal 3 times or more above the upper limit of the normal range\n7. Family history of haemochromatosis, thalassaemia or transferrin saturation \\> 50%\n8. Known history of iron overload\n9. Other known causes of anaemia (folic acid or vitamin B12 deficiency or haemoglobinopathies, etc.)\n10. Emergency surgery\n11. Use of iron, blood transfusion or related anaemia treatment within 12 weeks prior to surgery\n\nWithdrawal criteria:\n\n1. massive blood transfusion (≥ 10 red blood cells (RBC)\u002F24h)\n2. Preoperative interventions not performed according to standard\n3. Cancellation of surgery","ALL","18 Years",{"count":72,"type":73},110,"ESTIMATED","INTERVENTIONAL",[76],"NA","We used the preoperative intervention of iron sucrose in combination with human erythropoietin and vitamin C as an innovative combination therapy. This combined treatment strategy aims to improve perioperative anaemia in patients by promoting erythropoiesis and improving iron metabolism. Compared with previous perioperative intravenous iron supplementation, this innovative combination therapy strategy takes into account multiple aspects of iron metabolism as well as the biological mechanisms of erythropoiesis, providing a more comprehensive intervention. Management of perioperative anaemia in previous studies has largely relied on single intravenous iron supplementation therapy, and although this approach has been effective in raising iron levels, its effectiveness may be limited in patients who have impaired iron utilisation or in situations where concurrent stimulation of erythropoiesis is required. The use of iron sucrose in combination with human erythropoietin and vitamin C, on the other hand, is based on an integrative therapeutic concept aimed at providing a more comprehensive response to perioperative anaemia by simultaneously promoting effective iron utilisation and erythropoiesis.",[79,80,81],"Patient Blood Management","Cardiac Surgery","Iron Deficiency Anemia","2025-01-08",{"date":84,"type":85},"2025-01-10","ACTUAL",{"date":87,"type":85},"2023-03-15",{"date":89,"type":73},"2025-04-01",{"name":5,"class":6},1]