[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100375426":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":26,"responsibleParty":40,"collaborators":26,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":26,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":26,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":26},{"fullName":5,"class":6},"Helsinki University Central Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","IV-iron substitution: The intravenous iron formulation used in the study is ferric carboxymaltose and it will be administered two to four weeks before the surgery, aiming at four weeks. The dose of intravenous iron will be calculated according to the weight and haemoglobin level of the patients, however so that all the patients receive minimum 1000mg iv iron and the maximum dose is 20 mg\u002Fkg per day.",[13],"Drug: Ferric carboxymaltose",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo is NaCl 0.9% solution, which is administrated in the same way as the study drug",[19],"Drug: Placebos",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ferric carboxymaltose","Ferric carboxymaltose iv infusion",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebos","NaCl 0.9% infusion",[15],[32],{"name":33,"affiliation":5,"role":34},"Arto Kokkola, MD","STUDY_DIRECTOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+358-9-4711","arto.kokkola@hus.fi",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ville Sallinen","MD, Phd, Adj. Professor","100375426","phase-4-preoperative-intravenous-iron-therapy-in-patients-with-gastric-cancer-100375426",false,"NCT04168346","Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer","IRONSTOMACH","Inclusion Criteria:\n\n\\- Patients with gastric cancer who will undergo a gastrectomy\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Patients not in full understanding\n* Hemoglobin levels \\> 155 g\u002Fl for women and \\>167 g\u002Fl for men (upper reference limits for the laboratory of Helsinki University Hospital district) preoperatively.\n* Transferrin saturation level \\>50%\n* Emergency gastrectomy\n* Palliative gastrectomy\n* Acute bacterial infection\n* Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products\n* Clinical evidence of iron overload or disturbances in the utilisation of iron\n* Patients \\\u003C35 kg\n* Dialysis therapy for chronic renal failure\n* Hemochromatosis\n* Polycythemia vera\n* Pregnancy\n* Patients in need of direct blood transfusion ( Criteria for this are hemoglobin \\\u003C 80 g\u002Fl or \\\u003C 90 g\u002Fl if the patient is symptomatic or has a history of heart disease)","ALL","18 Years",{"count":54,"type":55},202,"ESTIMATED","INTERVENTIONAL",[58],"PHASE4","The main objective of this investigator initiated study is to study if preoperative intravenous iron is effective in reducing need for allogenic blood transfusion in patients with gastric cancer who will undergo a standardized gastrectomy including both total and subtotal gastrectomies. The hypothesis is that intravenous iron reduces the need for perioperative blood transfusions.",[61,62,63,64,65],"Gastric Cancer","Anemia","Surgery","Iron Deficiency Anemia","Surgery--Complications","NOT_YET_RECRUITING","2019-11-16",{"date":69,"type":70},"2019-11-19","ACTUAL",{"date":72,"type":55},"2019-11",{"date":74,"type":55},"2026-11",{"name":5,"class":6}]