Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000000 participants
OBSERVATIONAL
2012-01-31
2025-12-31
Brief Summary
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* 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.
* 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.
* The primary aim is to prove non-inferiority of the intervention (PBM) group when compared with the control group stratified by center.
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Detailed Description
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Study 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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control cohort
Standard care before implementation (pre-implementation)
No interventions assigned to this group
PBM cohort
After implementation of PBM program (post-implementation)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* minimum hospital stay of 24 h
* ≥ 18 years
Exclusion Criteria
* ophthalmologic or dermatologic or outpatient surgery
* all non-surgical anesthetic procedures
18 Years
ALL
Yes
Sponsors
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Vifor Pharma
INDUSTRY
B. Braun Melsungen AG
INDUSTRY
CSL Behring
INDUSTRY
Fresenius Kabi
INDUSTRY
Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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Professor Kai Zacharowski, M.D., Ph.D., FRCA
Professor Kai Zacharowski, M.D., Ph.D., FRCA
Locations
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Goethe University Hospital
Frankfurt am Main, Hesse, Germany
University Hospital Würzburg
Würzburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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PBM01
Identifier Type: -
Identifier Source: org_study_id
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