[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615036":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":65,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":24,"enrollmentInfo":82,"targetDuration":24,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":95,"whyStopped":24,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"intravenous (IV) iron","ACTIVE_COMPARATOR","If a participant is to receive IV iron, they will be scheduled to have two infusions, at the URMC Center for Perioperative Medicine (CPM). They will receive the iron through an IV, which is a small plastic tube inserted into a vein in the arm using a needle. This may require that saline water be inserted into the tube to keep the tube from clogging.",[13],"Drug: Treatment with intravenous iron",{"label":15,"type":16,"description":17,"interventionNames":18},"Sucrosomial Iron","EXPERIMENTAL","If a participant is to receive oral iron capsules, they will be provided with enough capsules to last until the date of surgery and will take 2 capsules every day.",[19],"Drug: Treatment with oral sucrosomial iron",{"label":21,"type":22,"description":23,"interventionNames":24},"3rd arm is for data collection only","NO_INTERVENTION","In addition, 25 patients refusing randomization, but accepting data collection, will be treated as per the standard of care, but will have data collected as for the randomized groups with the exception of no CBC or iron studies will be performed on the day of surgery unless as part of routine care unrelated to study participation.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"DRUG","Treatment with oral sucrosomial iron","blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies",[15],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"Treatment with intravenous iron","2 infusions of intravenous iron (ferumoxytol)",[9],[36],{"name":37,"affiliation":5,"role":38},"Michael P Eaton, MD","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":24,"email":44},"Michael Eaton, MD","CONTACT","585-275-7056","michael_eaton@urmc.rochester.edu",{"name":46,"role":42,"phone":24,"phoneExt":24,"email":47},"Marjorie Gloff, MD","marjorie_gloff@urmc.rochester.edu",[49],{"facility":5,"status":24,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Rochester","New York","14642","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-77.61556,43.15478,{"lat":59,"lon":58},[62,63,64],{"name":41,"role":42,"phone":43,"phoneExt":24,"email":44},{"name":46,"role":42,"phone":24,"phoneExt":24,"email":47},{"name":41,"role":38,"phone":24,"phoneExt":24,"email":24},{"type":38,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Michael Eaton","Principal Investigator",[69],{"name":70,"class":71},"Pharmanutra S.p.a.","INDUSTRY","100615036","phase-4-sucrosomial-vs-intravenous-iron-for-preoperative-anemia-100615036",false,"NCT07287371","Sucrosomial Vs Intravenous Iron for Preoperative Anemia","Randomized Trial of Sucrosomial Iron Vs Intravenous Iron for Preoperative Anemia (RSIVI)","RSIVI","Inclusion Criteria:\n\n* Age ≥18 years\n* Scheduled for elective cardiac surgical procedures, including:\n* Coronary artery bypass graft surgery (CABG)\n* Valve procedures\n* Aortic root procedures\n* Transcatheter aortic valve implantation (TAVI)\n* Hemoglobin \\\u003C12 g\u002FdL and ≥10 g\u002FdL on a complete blood count obtained at the Center for Perioperative Medicine pre operative visit\n* Evidence of iron deficiency\n* Able to provide informed consent\n* Able to understand spoken and written English\n\nExclusion Criteria:\n\n* Scheduled for cardiac surgery requiring deep hypothermia or circulatory arrest\n* Undergoing heart transplantation or ventricular assist device placement\n* Lacking capacity to provide informed consent or unable to understand spoken and written English\n* Baseline hemoglobin \\>12 g\u002FdL or \\\u003C10 g\u002FdL\n* Use of anticoagulant medications within 5 days of the Center for Perioperative Medicine visit, or planned initiation of anticoagulant therapy before surgery\n* History of hemoglobinopathy\n* History of hematologic malignancy\n* Bone marrow suppression from non nutritional causes\n* Vitamin B12 or folate deficiency\n* Known liver disease\n* Known kidney disease\n* Normal serum iron studies at baseline","ALL","18 Years",{"count":83,"type":84},75,"ESTIMATED","INTERVENTIONAL",[87],"PHASE4","50 patients with anemia scheduled for heart surgery or procedures will be randomized to receive either oral sucrosomial iron or standard-of-care intravenous iron before surgery to see if the oral iron is as effective as intravenous iron in increasing the red blood cell count.",[90,91],"Anemia","Iron Deficiency Anemia",[90,93,94],"Iron","Transfusion","NOT_YET_RECRUITING","2025-12-11",{"date":98,"type":99},"2025-12-17","ACTUAL",{"date":101,"type":84},"2025-12-31",{"date":103,"type":84},"2027-06-30",{"name":5,"class":6},1]