Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-01 @ 2:05 AM
Study NCT ID:
NCT06553833
Status:
COMPLETED
Last Update Posted:
2025-04-20
First Post:
2024-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Patient Blood Management in Patients Undergoing Major Surgery
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': 'ACTUAL', 'count': 25979}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2024-05-05', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inhospital Mortality', 'timeFrame': 'From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months', 'description': 'Number of dead participants at the end of hospitalization (inhospital mortality)'}], 'secondaryOutcomes': [{'measure': 'Local surgical complications', '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': 'Number of participants with local surgical complications'}, {'measure': 'Acute myocardial infarction', 'timeFrame': 'From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months', 'description': 'Number of participants with acute myocardial infarction'}, {'measure': 'Renal injury', 'timeFrame': 'From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months', 'description': 'Number of participants with renal injury (according to RIFLE criteria)'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 1000 months', 'description': 'Number of days a participant spends in hospital'}, {'measure': 'Readmission', 'timeFrame': 'From date of admission to hospital until 30 days thereafter', 'description': 'Number of participants readmitted to the same hospital within 30 days from first admission'}, {'measure': 'Transfusion reaction', 'timeFrame': 'From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months', 'description': 'Number of participants with a documented transfusion reaction'}, {'measure': 'Need of Intensive Care Unit treatment', 'timeFrame': 'From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months', 'description': 'Number of participants needing treatment in an Intensive Care Unit'}, {'measure': 'Respiratory complications', 'timeFrame': 'From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months', 'description': 'Number of participants with respiratory complications, defined as those needing ventilatory assistance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['major surgery', 'anemia', 'transfusion', 'patient blood management'], 'conditions': ['Major Surgery']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare patients who underwent major surgery and who were eligible to receive different management of their red blood count, namely, allogeneic transfusions with or without patient blood management, or blood management alone. Its main questions it aims to answer are:\n\nWhich group of patients dies more frequently: Patients who receive patient blood management only, patients who receive patient blood management and transfusions where indicated, or patients who are eligible to receive transfusions only.\n\nAmong these groups: which group of patients has more complications during hospital stay? Patients will either receive patients blood management, which is the management of anemia, bleeding and coagulation problems, will receive transfusions, that is, blood from other people, or a mix of both.', 'detailedDescription': 'Background:\n\nThere seems to be a clear relationship between hemoglobin level and inhospital morbidity and mortality. To mitigate negative effects of lower hemoglobin levels, that is, anemia, transfusions are given when the hemoglobin level of the patient reaches a point deemed detrimental by the treating health care personnel. Patient Blood Management (PBM) adds to the armamentarium of anemia therapy, starting typically well before transfusions are given, and sometimes beyond this point. PBM utilizes medical strategies to enhance the patients own red cell mass and to alleviate the ill effects of disease and bleeding on hematopoiesis and hemostasis.\n\nObjective:\n\nThe objectives of this study is to investigate the effects of different blood management strategies in patients undergoing major surgery, namely PBM exclusively or PBM with transfusion therapy combined, and compare them to standard transfusion therapy as regards inhospital mortality and morbidity.\n\nHypothesis:\n\nIt is hypothesized that participants who undergo major surgery and who were eligible to receive a combination of PBM and restrictive transfusion regime would have a lower mortality and less complications than participants receiving a liberal transfusion therapy without PBM, while participants opting to receive only PBM without transfusion support will have increased inhospital mortality and morbidity.\n\nSetting:\n\nThe study will be performed at HELIOS Klinikum Gotha (HKG) and HELIOS Klinikum Erfurt (HKE) which are two neighboring hospitals with overlapping personnel, purchasing, IT departments and standard operating procedures. Both hospitals offer basic, advanced and specialist care to their communities. HKG offers PBM to their patients, while HKE does not.\n\nData sources:\n\nData will be sourced from the hospital information systems of HKG and HKE. Diseases are coded with the ICD-10-GM (International Code of Diseases, Version 10, Germany) and procedures using the OPS code (Procedure Key, analogous to the International Code of Procedures).\n\nParticipants:\n\nAll adults undergoing major surgery and being treated between June 01, 2008 and December 31, 2020 in HKG and HKE will be eligible for enrollment when they were treated by a specialty that both hospitals offer.\n\nInterventions:\n\nStudy group 1: Participants in this group received full PBM measures as clinically appropriate, but were not transfused at all, no matter how low their hemoglobin dropped.\n\nStudy group 2:\n\nParticipants in this group received convenience measures of PBM and were transfused as deemed necessary in an environment where a restrictive transfusion strategy is encouraged.\n\nControl:\n\nThe control group was treated without systematic PBM offered to patients and transfusions were the only standard of care beyond the individual transfusion trigger.\n\nOutcome:\n\nPrimary outcome is inhospital mortality. Secondary outcomes are morbidity measures as outlined below.\n\nStudy design:\n\nThis is a dual-center, retrospective observational cohort study. Reporting of results will be performed in line with the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement extension of the STrengthening the Reporting of Observational studies in Epidemiology (STROBE) statement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all hospitalized participants admitted to HELIOS Klinikum Gotha and Erfurt between June 1, 2008 and December 31, 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult\n* undergoing major surgery\n\nExclusion Criteria:\n\n* treatment in a non-comparable specialty\n* transfer from admitting hospital within 6 h after arrival\n* requesting PBM/ transfusion-free therapy but not offered'}, 'identificationModule': {'nctId': 'NCT06553833', 'briefTitle': 'Outcomes of Patient Blood Management in Patients Undergoing Major Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Helios Klinik Gotha/Ohrdruf'}, 'officialTitle': 'Impact of Transfusions and Patient Blood Management on Outcomes in Patients Undergoing Major Surgery', 'orgStudyIdInfo': {'id': 'O-PBM3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group 1: PBM only', 'description': 'Participants in study group 1 receive full PBM while they opted not to receive transfusions.', 'interventionNames': ['Other: Patient Blood Management']}, {'label': 'Study group 2: PBM with transfusions', 'description': 'Participants in study group 2 receive partial PBM while they opted to receive transfusions. Transfusions are given by physicians encouraged to use a restrictive transfusion strategy. PBM is delivered to participants at a convenient time, resorting to a set of standard PBM measures rather than individualized care.', 'interventionNames': ['Biological: Allogeneic transfusion', 'Other: Patient Blood Management']}, {'label': 'Control group: Transfusions only', 'description': 'The control group is treated in an environment where PBM is not implemented and transfusion is the standard therapy for anemia, major bleeding, thrombopenia and coagulopathy beyond the transfusion trigger.', 'interventionNames': ['Biological: Allogeneic transfusion']}], 'interventions': [{'name': 'Allogeneic transfusion', 'type': 'BIOLOGICAL', 'description': 'Anemia is treated by administering donor red cells, and bleeding or coagulopathy by plasma, platelets or other donor blood products.', 'armGroupLabels': ['Control group: Transfusions only', 'Study group 2: PBM with transfusions']}, {'name': 'Patient Blood Management', 'type': 'OTHER', 'description': 'PBM is a strategy to manage the participants own blood. Its focus is on anemia, bleeding and coagulation management (using predominantly pharmaceutical and technological means).', 'armGroupLabels': ['Study group 1: PBM only', 'Study group 2: PBM with transfusions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99867', 'city': 'Gotha', 'country': 'Germany', 'facility': 'Helios Klinikum', 'geoPoint': {'lat': 50.94823, 'lon': 10.70193}}], 'overallOfficials': [{'name': 'Petra Seeber', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HELIOS Klinikum Gotha'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helios Klinik Gotha/Ohrdruf', 'class': 'OTHER'}, 'collaborators': [{'name': 'HELIOS Hospital, Erfurt, Germany', 'class': 'OTHER'}, {'name': 'Matthias Lucas', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Petra Seeber', 'investigatorAffiliation': 'Helios Klinik Gotha/Ohrdruf'}}}}