[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462651":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":59,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous Ferric Derisomaltose","EXPERIMENTAL","One single dose of ferric derisomaltose, 1000 mg Intravenous over at least 20 minutes.",[13],"Drug: Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]",{"label":15,"type":16,"description":17,"interventionNames":18},"Oral Iron","ACTIVE_COMPARATOR","ferrous sulfate 65 mg once daily for 42 days.",[19],"Drug: Ferrous Sulfate 65 mg elemental iron (325 mg tablets)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]","Single Dose of IV Iron",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Ferrous Sulfate 65 mg elemental iron (325 mg tablets)","Once daily by mouth for 42 days",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Stephen Boone, MD","CONTACT","8324099126","Stephen.Boone@bcm.edu",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Kelly R Keene, BSN","8323682476","kelly.keene@bcm.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Ben Taub Hospital","RECRUITING","Houston","Texas","77030","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-95.36327,29.76328,{"lat":54,"lon":53},[57],{"name":33,"role":34,"phone":26,"phoneExt":26,"email":58},"stephen.boone@bcm.edu",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Stephen Boone MD","Assistant Professor",[64],{"name":65,"class":66},"Pharmacosmos Therapeutics, Inc.","UNKNOWN","100462651","phase-3-iv-iron-trial-for-anemia-related-to-uterine-bleeding-in-female-patients-presenting-to-the-emergency-department-100462651",false,"NCT05304442","IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department","Intravenous Ferric Derisomaltose for Moderate to Severe Anemia Due to Uterine Bleeding in the Emergency Department: a Randomized Trial","Inclusion Criteria:\n\n* Sub-acute or chronic uterine blood loss;\n* Moderate to Severe Anemia, defined as Hgb less than or equal to 9.0 g\u002Fdl;\n* Iron deficiency: Serum ferritin less than or equal to 30 ng\u002FmL;\n* Eligible for discharge from the ED following treatment;\n* Patient able to return for planned follow-up visits at 3 and 6 weeks;\n* Patient able to be reached by telephone;\n* Willing and able to provide consent for participation.\n\nExclusion Criteria:\n\n* Patient requiring hospitalization for any reason;\n* Pregnant or nursing;\n* Incarcerated\u002FPrisoner;\n* Weight \\\u003C 50 kg;\n* History of hypersensitivity reactions, as specified, known hypersensitivity to any formulation of parenteral iron;\n* History of any anaphylactic allergy;\n* Recent receipt of IV iron, erythropoiesis-stimulating agents;\n* Erythropoiesis-stimulating agent use within 8 weeks prior to ED visit;\n* Parenteral iron within 4 weeks prior to ED visit;\n* Scheduled\u002Fplanned use of parenteral iron or ESA during study period;\n* Receipt of blood transfusion at index visit;\n* Planned elective major surgery during study period;\n* Other current or recent hematologic therapy, as specified;\n* Current or planned use of antithrombotic therapy (antiplatelet agents or anticoagulants) within study period (Non-aspirin NSAIDs are NOT a contraindication);\n* Known bleeding disorder platelets \\\u003C 100,000';\n* Other significant underlying comorbidity, as specified:\n* Active rheumatologic disease, or rheumatologist disease requiring treatment, such as rheumatoid arthritis, systemic lupus erythematosus, or mixed connective tissue disease;\n* Acute heart failure or NYHA II-IV chronic heart failure;\n* Inflammatory bowel disease;\n* Cirrhosis or Decompensated liver disease;\n* Chronic kidney disease, stage III or greater (eGFR \\\u003C 60);\n* Current Systemic Infection (e.g. pneumonia, pelvic inflammatory disease, pyelonephritis). \\*Cystitis or cervicitis is NOT an exclusion\n* Any other medical or surgical condition that in the opinion of the treating physician may result in patient being unsuitable for trial participation","FEMALE","18 Years","65 Years",{"count":78,"type":79},40,"ESTIMATED","INTERVENTIONAL",[82],"PHASE3","The primary aim of this randomized trial is to assess the efficacy of IV Ferric Derisomaltose vs Oral Iron in the management of women with severe Iron Deficiency Anemia due to Uterine Bleeding in the emergency department.",[85,86],"Anemia, Iron Deficiency","Uterine Bleeding",[88,89,90,86],"IV Iron","Emergency Department","Iron Deficiency Anemia","2024-12-03",{"date":93,"type":94},"2024-12-05","ACTUAL",{"date":96,"type":94},"2022-09-15",{"date":98,"type":79},"2025-04",{"name":5,"class":6},1]