[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590707":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":31,"interventions":43,"overallOfficials":24,"centralContacts":24,"locations":49,"responsibleParty":70,"collaborators":24,"id":72,"slug":24,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":24,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":24,"enrollmentInfo":80,"targetDuration":24,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":24,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Englewood Hospital and Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in hemoglobin levels","Delta change of hemoglobin levels assessed at T1 in Sucrosomial Iron group to demonstrate non-inferiority compared to the Standard of Care.","30 days",{"measure":14,"description":15,"timeFrame":16},"Financial Cost","Financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV)","30 Days",[18,21],{"measure":19,"description":20,"timeFrame":16},"Transfusion requirements","Reduction in transfusion requirements, measured by the number of transfusions needed during the study period.",{"measure":22,"description":23,"timeFrame":16},"Length of Stay","Length of hospital stay measured from the date of surgery to discharge. Length of ICU stay measured from date of surgery to date of ICU discharge.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"Sucrosomial® Iron","EXPERIMENTAL","Patients will receive iron supplementation with Sucrosomial® Iron",[37],"Dietary Supplement: Sucrosomial Iron (SI)",{"label":39,"type":40,"description":41,"interventionNames":42},"Iron Sucrose injections.","ACTIVE_COMPARATOR","Patients will receive standard of care Iron Sucrose injections.",[37],[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":24},"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.",[39,33],[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Englewood Hospital","RECRUITING","Englewood","New Jersey","07631","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-73.97264,40.89288,{"lat":62,"lon":61},[65],{"name":66,"role":67,"phone":68,"phoneExt":24,"email":69},"Dara Herman","CONTACT","201-894-3944","dara.herman@ehmchealth.org",{"type":71,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","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":81,"type":82},40,"ESTIMATED","INTERVENTIONAL",[85],"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",[88],"Cardiac Surgery","2025-08-04",{"date":91,"type":92},"2025-08-07","ACTUAL",{"date":94,"type":92},"2025-06-30",{"date":96,"type":82},"2026-06-30",{"name":5,"class":6},1]