[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597727":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":55,"collaborators":19,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":19,"enrollmentInfo":68,"targetDuration":19,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":36,"whyStopped":19,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Feasibility","EXPERIMENTAL","Feasibility and safety of home-based blood count measurement and transfusions",[13],"Device: Feasibility and safety of home-based blood count measurement and transfusions",[15],{"type":16,"name":11,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Feasibility and safety of home-based blood count measurement and transfusions in patients with acute myeloid leukemia",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Lars Kjeldsen, MD","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Iben H Nielsen, PhD","CONTACT","+4526227757","iben.husted.nielsen@regionh.dk",{"name":22,"role":27,"phone":31,"phoneExt":19,"email":32},"+4530224032","lars.kjeldsen.01@regionh.dk",[34],{"facility":35,"status":36,"city":37,"state":19,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Rigshospitalet","RECRUITING","Copenhagen","2100","Denmark","DK",{"type":42,"coordinates":43},"Point",[44,45],12.56553,55.67594,{"lat":45,"lon":44},[48,50,52,53],{"name":49,"role":27,"phone":28,"phoneExt":19,"email":29},"Iben H Nielsen, Clinical Nurse Specialist, PhD",{"name":51,"role":27,"phone":31,"phoneExt":19,"email":32},"Lars Kjeldsen, Consultant, MD",{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"name":49,"role":54,"phone":19,"phoneExt":19,"email":19},"SUB_INVESTIGATOR",{"type":23,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Iben Husted Nielsen","Clinical nurse specialist, PhD","100597727","feasibility-and-safety-of-home-blood-count-measurement-and-transfusions-in-patients-with-acute-myeloid-leukemia-100597727",false,"NCT07062250","Feasibility and Safety of Home Blood Count Measurement and Transfusions in Patients With Acute Myeloid Leukemia","Feasibility and Safety of Home Blood Count Measurement and Transfusions by Systematically Educated Patients With Acute Myeloid Leukemia","HOME-BLOOD","Inclusion Criteria:\n\n* ≥ 18 years old\n* newly diagnosed with AML within four weeks\n* scheduled to receive home-based chemotherapy.\n\nExclusion Criteria:\n\n* Patients who do not understand or speak Danish\n* Incapable of performing home-based CBC measurements and administration of transfusions.\n* Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.","ALL","18 Years",{"count":69,"type":70},15,"ESTIMATED","INTERVENTIONAL",[73],"NA","The aim is to investigate the feasibility, safety, and complication rates of patient's self-measurement of CBC and self-administration of blood and platelet transfusions at home and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion. Furthermore, to evaluate the health economic consequences of our innovative approach, specifically, the anticipated reduction in reliance on nurse-driven services.\n\nThis study is a single-arm feasibility study with patients newly diagnosed with Acute Myeloid Leukemia. The study will be conducted at the Department of Hematology, Rigshospitalet.\n\nPatients are included if they are ≥ 18 years old, newly diagnosed with AML within four weeks, and scheduled to receive home-based chemotherapy. Patients are excluded if they do not speak Danish or are not assessed to be capable of performing home-based CBC measurements and administration of transfusions. Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.\n\nIncluded patients will receive comprehensive training and certification to perform CBC measurements, self-administer transfusions, and monitor selected vital parameters including blood pressure, pulse rate, oxygen saturation, and temperature.\n\nIt is hypothesized that the study can demonstrate the logistic, technical, and economic feasibility and safety of educating patients with AML undergoing intensive chemotherapy, to independently conduct self-measurement of complete blood count (CBC), self-administration of transfusions at home, and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion.",[76],"Acute Myeloid Leukaemia (AML)",[78,79,80,81,82,83],"Home transfusion","Hematology","Blood transfusion","Home based treatment","Acute leukemia","Patient empowerment","2025-07-02",{"date":86,"type":87},"2025-07-14","ACTUAL",{"date":89,"type":87},"2024-04-01",{"date":91,"type":70},"2026-03",{"name":5,"class":6},1]