Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-02-19 @ 12:37 AM
Study NCT ID:
NCT02147795
Status:
RECRUITING
Last Update Posted:
2023-03-10
First Post:
2014-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The German Patient Blood Management Network
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2014-05-13', 'studyFirstSubmitQcDate': '2014-05-27', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Outcome for and after PBM program', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': 'composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the PBM program'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': 'length of stay on the intensive care unit, total hospital stay'}, {'measure': 'haemotherapy', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': 'the quantitative utilization of allogeneic RBC units, platelet concentrates, other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and any other haemotherapy (including use of cell salvage'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Patient Blood Management', 'Red Blood Cell Transfusion Practice', 'Patient Safety', 'Anemia', 'Clinical Outcome', 'perioperative care'], 'conditions': ['Clinical Safety of a PBM Program']}, 'referencesModule': {'references': [{'pmid': '37380568', 'type': 'DERIVED', 'citation': 'Meybohm P, Schmitt E, Choorapoikayil S, Hof L, Old O, Muller MM, Geisen C, Seifried E, Baumhove O, de Leeuw van Weenen S, Bayer A, Friederich P, Brautigam B, Friedrich J, Gruenewald M, Elke G, Molter GP, Narita D, Raadts A, Haas C, Schwendner K, Steinbicker AU, Jenke DJ, Thoma J, Weber V, Velten M, Wittmann M, Weigt H, Lange B, Herrmann E, Zacharowski K; German Patient Blood Management Network Collaborators. German Patient Blood Management Network: effectiveness and safety analysis in 1.2 million patients. Br J Anaesth. 2023 Sep;131(3):472-481. doi: 10.1016/j.bja.2023.05.006. Epub 2023 Jun 26.'}, {'pmid': '35220460', 'type': 'DERIVED', 'citation': 'Schmitt E, Meybohm P, Neef V, Baumgarten P, Bayer A, Choorapoikayil S, Friederich P, Friedrich J, Geisen C, Guresir E, Grunewald M, Gutjahr M, Helmer P, Herrmann E, Muller M, Narita D, Raadts A, Schwendner K, Seifried E, Stark P, Steinbicker AU, Thoma J, Velten M, Weigt H, Wiesenack C, Wittmann M, Zacharowski K, Piekarski F; German PBM Network Collaborators. Preoperative anaemia and red blood cell transfusion in patients with aneurysmal subarachnoid and intracerebral haemorrhage - a multicentre subanalysis of the German PBM Network Registry. Acta Neurochir (Wien). 2022 Apr;164(4):985-999. doi: 10.1007/s00701-022-05144-7. Epub 2022 Feb 26.'}]}, 'descriptionModule': {'briefSummary': '* This epidemiological trial will determine whether the implementation of a PBM program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort\n* Primary endpoint is a composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the PBM program.\n* Secondary endpoints are the length of stay on the intensive care unit, total hospital stay and the quantitative utilization of allogeneic RBC units, platelet concentrates, other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and cell saver systems during hospital stay.\n* The primary aim is to prove non-inferiority of the intervention (PBM) group when compared with the control group stratified by center.', 'detailedDescription': 'Background: The transfusion of allogeneic red blood cell units might be associated with increased morbidity and mortality due to infectious, immunological, pulmonary and thromboembolic complications. However, transfusion practice currently varies significantly between hospitals and even between physicians and Patient Blood Management programs have not been implemented nationwide in Germany yet. Patient Blood Management (PBM) concepts aim to identify and optimize patients at risk of allogeneic blood transfusions, to promote blood-sparing techniques and restrictive transfusion practices. A rational use of red blood cell concentrates and safe clinical transfusion practice is mandatory. The purpose of the German PBM network is to evaluate the safety of a standardized, evidence-based Patient Blood management concept.\n\nStudy Design and Methods: This epidemiological study is a follow-up of a study that is already being carried out in four German university hospitals. This new prospective, multi-centre trial comprises approximately 20 different hospitals of varying size and levels of patient care. A patient-centred, evidence-based Patient Blood Management program will be enrolled in each of these hospitals reforming the care of adult patients undergoing any type of surgery. This PBM program includes the following three main pillars: 1) preoperative optimization of hemoglobin levels in high-risk patients with anaemia, 2) standardization of transfusion practice and transfusion triggers according to evidence-based guidelines and 3) alternatives to transfusion of allogeneic RBC concentrates and blood-sparing techniques (like routine use of cell saver systems, point-of-care diagnostics, optimized coagulation management, restrictive blood sampling).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult surgical patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all surgeries with a general or local anaesthetic\n* minimum hospital stay of 24 h\n* ≥ 18 years\n\nExclusion Criteria:\n\n* \\< 18 years\n* ophthalmologic or dermatologic or outpatient surgery\n* all non-surgical anesthetic procedures'}, 'identificationModule': {'nctId': 'NCT02147795', 'briefTitle': 'The German Patient Blood Management Network', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients', 'orgStudyIdInfo': {'id': 'PBM01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control cohort', 'description': 'Standard care before implementation (pre-implementation)'}, {'label': 'PBM cohort', 'description': 'After implementation of PBM program (post-implementation)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kai Zacharowski, MD PhD', 'role': 'CONTACT', 'email': 'kai.zacharowski@kgu.de', 'phone': '+49-69-6301-5998'}], 'facility': 'Goethe University Hospital', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Würzburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Patrick Meybohm, MD', 'role': 'CONTACT', 'email': 'meybohm_p@ukw.de'}], 'facility': 'University Hospital Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'centralContacts': [{'name': 'Kai D Zacharowski, Prof, MD, PhD', 'role': 'CONTACT', 'email': 'Direktion.Anaesthesie@kgu.de', 'phone': '0049 69 6301', 'phoneExt': '5998'}, {'name': 'Patrick Meybohm, M.D', 'role': 'CONTACT', 'email': 'patientbloodmanagement@kgu.de', 'phone': '0049 6906301', 'phoneExt': '5998'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vifor Pharma', 'class': 'INDUSTRY'}, {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, {'name': 'CSL Behring', 'class': 'INDUSTRY'}, {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Kai Zacharowski, M.D., Ph.D., FRCA', 'investigatorFullName': 'Professor Kai Zacharowski, M.D., Ph.D., FRCA', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}