[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494117":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":40,"locations":48,"responsibleParty":64,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":32,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":32,"enrollmentInfo":80,"targetDuration":32,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":50,"whyStopped":32,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","Iron to be administered as intravenous ferric derisomaltose:\n\nWhere Hb (hemoglobin) ≥100 g\u002FL, dosage according to body weight is as follows:\n\nBody weight \\\u003C50 kg: 500mg; Body weight 50 to \\\u003C70 kg: 1000 mg; Body weight ≥70 kg: 1500 mg.\n\nWhere Hb \\\u003C100 g\u002FL, dosage according to body weight is as follows:\n\nBody weight \\\u003C50 kg: 500mg; Body weight 50 to \\\u003C70 kg: 1500mg; Body weight ≥70 kg: 2000 mg.\n\nThe maximial dose should not exceed 20mg\u002Fkg body weight, rounded off to the nearest 100mg",[13],"Drug: Ferric derisomaltose",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Iron to be administered as oral ferrous succinate:\n\n1 tablet (100 mg) tid (three times daily), starting on the first postoperative day and continuing for 4 weeks.",[19],"Drug: Ferrous succinate",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ferric derisomaltose","Single intravenous dose ferric derisomaltose",[9],[27],"MONOFER®",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Ferrous succinate","Daily oral dose of 100 mg iron (ferrous succinate) tid postoperatively",[15],null,[34,37],{"name":35,"affiliation":5,"role":36},"Weiyun Chen, MD","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":5,"role":39},"Jianxiong Shen, MD","STUDY_DIRECTOR",[41,45],{"name":38,"role":42,"phone":43,"phoneExt":32,"email":44},"CONTACT","01069152701","sjxpumch@163.com",{"name":35,"role":42,"phone":46,"phoneExt":32,"email":47},"13691412863","chenweiyun@pumch.cn",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":57,"coordinates":58},"Point",[59,60],116.39723,39.9075,{"lat":60,"lon":59},[63],{"name":38,"role":42,"phone":32,"phoneExt":32,"email":44},{"type":36,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Weiyun Chen","Principal Investigator",[68],{"name":69,"class":70},"Pharmacosmos A\u002FS","INDUSTRY","100494117","phase-4-the-effects-of-ferric-derisomaltose-on-postoperative-anemia-in-spinal-deformity-surgery-100494117",false,"NCT05714007","The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery","The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study","Inclusion Criteria\n\n1. Age ≥18 years\n2. Received spinal deformity surgery\n3. 70 g\u002FL ≤ Hb ≤ 110 g\u002FL at POD1, or Hb at POD1 showed a decrease of\n\n   ≥20 g\u002FL compared with baseline\n4. Informed consent was obtained voluntarily\n\nExclusion Criteria\n\n1. Women who are pregnant, breastfeeding, or planning to become pregnant.\n2. known serious hypersensitivity to other parenteral iron products\n3. Non-iron deficiency anemia (e.g., hemolytic anemia)\n4. Decompensated liver insufficiency\n5. Coexisting active infection\n6. Drug abuse, including but not limited to opioids, amphetamines, methamphetamine, ketamine, etc.\n7. Other conditions that the investigator considers inappropriate for participation (e.g. deafness, Parkinson's disease, communication disorders, etc.)\n8. Participation in another clinical trial within three months prior to this study.","ALL","18 Years",{"count":81,"type":82},120,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","The prognosis of patients undergoing spinal deformity surgery is often compromised by perioperative anemia due to iron deficiency. The aim of this randomized, controlled trial was to evaluate whether postoperative ferric derisomaltose intravenous injection may improve anemia and prognosis in patients undergoing spinal deformity surgery comparing with oral iron. Participants will be randomly assigned to the treatment group (intravenous ferric derisomaltose) and the control group (oral iron). Changes in hemoglobin concentration, percentage of anemia correction, changes in iron indicators, patient quality of life, and incidence of adverse events will be analyzed to evaluate the efficacy and safety of iron isomaltoside infusion.",[88,89,90,91],"Perioperative Anemia","Surgery","Spinal Deformity","Adult",[93,94,95,96],"spinal deformity surgery","perioperative anemia","ferric derisomaltose","adult","2025-06-10",{"date":99,"type":100},"2025-06-13","ACTUAL",{"date":102,"type":100},"2023-08-31",{"date":104,"type":82},"2025-12",{"name":5,"class":6},1]