[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100432633":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":77,"collaborators":81,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":51,"enrollmentInfo":95,"targetDuration":51,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":49,"whyStopped":51,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"St. Antonius Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous iron (ferric derisomaltose)","EXPERIMENTAL","The intervention consists of a single dose of ferric derisomaltose (Monofer®) 100 mg\u002FmL solution for infusion (Monofer® is a registered product with a marketing authorization in the Netherlands (RVG number: 103070). Manufacturer: Pharmacosmos A\u002FS, Denmark. Dutch marketing authorization holder: Cablon Medical B.V). The method of administration and dosage of the investigational medication are standard treatment. The ferric derisomaltose dose will calculated for each patient depending on body weight (20mg\u002Fkg) and diluted in 250 ml NaCl 0.9%. Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards",[13],"Drug: Ferric Derisomaltose 100 MG\u002FML",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Single dose of sodium chloride 0.9% (250ml). Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards",[19],"Drug: Sodium chloride",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ferric Derisomaltose 100 MG\u002FML","Postoperative treatment with a single dose IVI (ferric derisomaltose), with a dose of 20mg\u002Fkg in approximately 60 minutes.",[9],[27],"Monofer",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sodium chloride","Postoperative treatment with a single dose NaCl 0.9% in approximately 60 minutes.",[15],[15],[34],{"name":35,"affiliation":5,"role":36},"Peter Noordzij, MD, PhD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","883203000","+ 31 (0)","p.noordzij@antoniusziekenhuis.nl",{"name":44,"role":39,"phone":40,"phoneExt":41,"email":45},"Rosa Smoor, MD","r.smoor@antoniusziekenhuis.nl",[47,63],{"facility":48,"status":49,"city":50,"state":51,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Amphia Hospital","RECRUITING","Breda",null,"Netherlands","NL",{"type":55,"coordinates":56},"Point",[57,58],4.77596,51.58656,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":51,"phoneExt":51,"email":51},"Thijs Rettig",{"facility":64,"status":49,"city":65,"state":51,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"St Antonius Hospital","Nieuwegein",{"type":55,"coordinates":67},[68,69],5.08056,52.02917,{"lat":69,"lon":68},[72,74],{"name":73,"role":39,"phone":51,"phoneExt":51,"email":51},"Peter Noordzij",{"name":75,"role":76,"phone":51,"phoneExt":51,"email":51},"Rosa Smoor","SUB_INVESTIGATOR",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"SPONSOR_INVESTIGATOR","dr. P. Noordzij","Principal investigator",[82],{"name":83,"class":84},"Pharmacosmos A\u002FS","INDUSTRY","100432633","phase-4-intravenous-iron-to-treat-postoperative-anemia-in-older-cardiac-surgery-patients-100432633",false,"NCT04913649","Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients","Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients: a Randomized Controlled Trial'","AGE-ANEMIA","Inclusion Criteria:\n\n* Mentally competent with age ≥ 70 years\n* Elective AVR or CABG surgery\n* Expected uncomplicated postoperative trajectory, defined as:\n* No inotropic agents or ventilation at time of final inclusion (POD 1)\n* Expected discharge to general ward at POD 1\n* Moderate postoperative IDA, defined as:\n* Hb between 85 and 110 g\u002FL and\n* Ferritin \\\u003C100 µg\u002FL or\n* Iron saturation (TSAT) \\\u003C 20%\n\nExclusion Criteria:\n\n* Medical history of iron overload\u002Fhaemochromatosis\n* Medical history of liver cirrhosis or ALT\u002FAST value in blood serum triple of normal value (female patients: ALT \\>120, AST \\>105 U\u002FL. Male patients: ALT\\>150, AST\\>135 U\u002FL)\n* Severe renal failure (eGFR\\\u003C15ml\u002Fmin\u002F1.73m2)\n* Recent treatment with IVI (\\\u003C12 weeks prior)\n* Serious or severe allergic reaction to IVI in medical history\n* Severe asthma or eczema in medical history (atopic constitution)","ALL","70 Years",{"count":96,"type":97},310,"ESTIMATED","INTERVENTIONAL",[100],"PHASE4","Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients. The objective of the study is to determine the effect of treatment of postoperative iron deficiency anemia with intravenous iron on disability 90 days after surgery. This will be evaluated in a randomized placebo-controlled double blind two-center trial in which 310 elective cardiac surgery patients will be included.",[103],"Iron Deficiency Anemia",[105,106,107,108],"Cardiac surgery","Postoperative anemia","Intravenous iron","Postoperative disability","2026-04-22",{"date":111,"type":112},"2026-04-27","ACTUAL",{"date":114,"type":112},"2021-09-23",{"date":116,"type":97},"2026-12",{"name":79,"class":6},2]