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| Name | Class |
|---|---|
| Vifor Pharma | INDUSTRY |
| B. Braun Melsungen AG | INDUSTRY |
| CSL Behring | INDUSTRY |
| Fresenius Kabi |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control cohort | Standard care before implementation (pre-implementation) | ||
| PBM cohort | After implementation of PBM program (post-implementation) |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite Outcome for and after PBM program | 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 | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | length of stay on the intensive care unit, total hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| haemotherapy | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult surgical patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai D Zacharowski, Prof, MD, PhD | Contact | 0049 69 6301 | 5998 | Direktion.Anaesthesie@kgu.de |
| Patrick Meybohm, M.D | Contact | 0049 6906301 | 5998 | patientbloodmanagement@kgu.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goethe University Hospital | Recruiting | Frankfurt am Main | Hesse | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37380568 | Derived | 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. | |
| 35220460 |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| INDUSTRY |
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| Participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| University Hospital Würzburg | Recruiting | Würzburg | Germany |
|
| Derived |
| 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. |