Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-17 @ 12:48 PM
Study NCT ID:
NCT06345469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost Analysis of Therapies for Severe Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 640}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cost-effectiveness', 'timeFrame': 'From date of admission to hospital until the date of discharge or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months', 'description': 'The study evaluates costs incurred to treat severe anemia and how these relates to its effect on reduction of inhospital mortality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anemia', 'costs', 'transfusion', 'patient blood management'], 'conditions': ['Severe Anemia']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the costs that occur when participants with severe anemia are treated with blood transfusions or with patient blood management (PBM). PBM means that the body of the participant is stimulated to produce new blood by itself rather than receiving it from a blood donor, and to reduce blood losses.\n\nThe main question the study aims to answer is: Do participants treated with transfusions incur the same treatment costs than participants treated with PBM? And how much costs are this in relation to the lives saved by the therapy of severe anemia?', 'detailedDescription': 'Background:\n\nSevere anemia is a condition that is associated with increased morbidity and mortality in hospitalized patients. In an effort to treat severe anemia, transfusions and/or Patient Blood Management are provided with the goal to reduce morbidity and mortality. This treatment naturally incurs costs. Several studies already tried to evaluate the costs of transfusions and PBM and to compare them. However, a comparison of the therapy costs of severe anemia and their cost effectiveness is not available.\n\nObjective: It is the objective of this study to assess therapeutic costs of severe anemia and to compare the cost effectiveness of transfusion therapy and PBM in relation to their effect on inhospital mortality.\n\nHypothesis: It is hypothesized that the therapy of severely anemic participants who received PBM and who receive transfusions is equally cost effective as regards its ability to reduce in-hospital mortality.\n\nSetting: The study will be performed at HELIOS Klinikum Gotha, a hospital with general, advanced and specialized care which offers not only transfusions but also PBM.\n\nData sources: Data will be sourced from the hospital information system as well as from chart review.\n\nParticipants: All adult patients treated between 2008 and 2020 in Helios Klinikum Gotha who had a nadir hemoglobin of less than 8 g/dL and who opted to be treated with PBM, but not with allogeneic transfusions. A control group will be matched from all other severely anemic patients treated in the same time period but who opted to receive transfusions.\n\nInterventions: allogeneic transfusion therapy with red blood cells according to the standards of the Federal Chamber of Physicians in Germany or Patient Blood Management only without transfusion of allogeneic red cells.\n\nOutcome:\n\nThe primary outcome is the cost-effectiveness of transfusion therapy and PBM to reduce in-hospital mortality.\n\nCosts will be calculated by the top-down and the bottom-up method and the Incremental Cost Effectiveness Ratio (ICER) will be calculated in relation to mortality reduction.\n\nStudy design:\n\nThis is a retrospective observational cohort study. Reporting of the results will be performed in line with the CHEERS (Consolidated Health Economic Evaluation Reporting Standards 2022) statement.\n\nThe study will be guided by a study protocol with an attached statistical analysis plan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants admitted to Helios Klinikum Gotha, Germany, between 2008 and 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult (\\> 18 years at admission)\n* hemoglobin nadir of \\< 8 g/dL\n\nExclusion Criteria:\n\n* participants treated by physicians not related to Helios Klinikum Gotha'}, 'identificationModule': {'nctId': 'NCT06345469', 'briefTitle': 'Cost Analysis of Therapies for Severe Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Helios Klinik Gotha/Ohrdruf'}, 'officialTitle': 'Cost Effectiveness Analysis of Transfusion Therapy and Patient Blood Management in Patients With Severe Anemia', 'orgStudyIdInfo': {'id': 'O-PBM2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PBM only', 'description': 'The Study group received comprehensive Patient Blood Management without allogeneic transfusions to treat their severe anemia.', 'interventionNames': ['Other: Patient blood management (PBM)']}, {'label': 'PBM with transfusion', 'description': 'The Control group opted to be treated with allogeneic transfusions together with convenience measures of PBM.', 'interventionNames': ['Other: Patient blood management (PBM)', 'Biological: Allogeneic transfusion']}], 'interventions': [{'name': 'Patient blood management (PBM)', 'type': 'OTHER', 'description': 'PBM means the medical enhancement of the participants own hematopoietic reserve to treat anemia and to reduce the ill effects of disease and bleeding on hematopoiesis and homeostasis.', 'armGroupLabels': ['PBM only', 'PBM with transfusion']}, {'name': 'Allogeneic transfusion', 'type': 'BIOLOGICAL', 'description': 'transfusion of donor red cells', 'armGroupLabels': ['PBM with transfusion']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marisa Eichner', 'role': 'CONTACT', 'email': 'marisaeichner@web.de', 'phone': '+49-17672731730'}], 'overallOfficials': [{'name': 'Petra Seeber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HELIOS Klinikum Gotha'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helios Klinik Gotha/Ohrdruf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Marisa Eichner', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Petra Seeber', 'investigatorAffiliation': 'Helios Klinik Gotha/Ohrdruf'}}}}