[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590707":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":26,"responsibleParty":47,"collaborators":25,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":25,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":25,"enrollmentInfo":58,"targetDuration":25,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":25,"overallStatus":29,"whyStopped":25,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Englewood Hospital and Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sucrosomial® Iron","EXPERIMENTAL","Patients will receive iron supplementation with Sucrosomial® Iron",[13],"Dietary Supplement: Sucrosomial Iron (SI)",{"label":15,"type":16,"description":17,"interventionNames":18},"Iron Sucrose injections.","ACTIVE_COMPARATOR","Patients will receive standard of care Iron Sucrose injections.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Sucrosomial Iron (SI)","The Sucrosomial Iron (SI) you may receive is a considered a supplement, so it has not been approved by the U.S. Food \\& Drug Administration (FDA) for sale. However, it is available for over-the-counter purchase. Sucrosomial Iron (SI) has been developed by PharmaNutra.",[15,9],null,[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Englewood Hospital","RECRUITING","Englewood","New Jersey","07631","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-73.97264,40.89288,{"lat":39,"lon":38},[42],{"name":43,"role":44,"phone":45,"phoneExt":25,"email":46},"Dara Herman","CONTACT","201-894-3944","dara.herman@ehmchealth.org",{"type":48,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100590707","early-phase-1-pilot-study-evaluating-the-advantages-of-sucrosomial-iron-post-operative-supplementation-vs-standard-of-care-after-cardiac-surgery-100590707",false,"NCT06970925","Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery","Pilot Study Evaluating Efficacy and Economic Advantage of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care in Patients After Cardiac Surgery","Inclusion Criteria:\n\n* ICU hospitalized patients who underwent non-emergent cardiac surgery\n* Post operative iron deficient or anemic patients (Hb\\\u003C 12 for both men and women).\n* Patients following the same pre-operative protocol\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Post operative day 1 Hg \\\u003C9\n* Age \\>90 years\n* Patients with cancer or other chronic conditions that impair erythropoiesis (e.g. MDS)\n* Stage 3, 4 renal disease\n* Intraoperative transfusion of PRBC","ALL","18 Years",{"count":59,"type":60},40,"ESTIMATED","INTERVENTIONAL",[63],"EARLY_PHASE1","Primary objective: to evaluate the non-inferiority in terms of improvement of hemoglobin (Hg) levels within 30 days postoperatively between two proposed treatments.\n\nSecondary objective: to evaluate the financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV), while demonstrating non-inferiority in the improvement of hemoglobin levels, reduction in transfusion requirements, and reduction of hospital\u002FICU stay length",[66],"Cardiac Surgery","2025-08-04",{"date":69,"type":70},"2025-08-07","ACTUAL",{"date":72,"type":70},"2025-06-30",{"date":74,"type":60},"2026-06-30",{"name":5,"class":6},1]