An observational study in Clinical Safety of a PBM Program, sponsored by Johann Wolfgang Goethe University Hospital. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by Johann Wolfgang Goethe University Hospital · Observational
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).
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 1,000,000 is above the median of 270 across 368 observational studies indexed under Anemia.
Browse Anemia studies →Johann Wolfgang Goethe University Hospital is the lead sponsor of 160 studies on the registry; 8 are open to participants now.
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Adult surgical patients
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Exclusion Criteria:
Standard care before implementation (pre-implementation)
After implementation of PBM program (post-implementation)
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
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of stay
length of stay on the intensive care unit, total hospital stay
Time frame: 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
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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