Transfusion of whole blood, erythrocyte concentrate, thrombocyte concentrate and massive transfusion (G-DRG OPS 8-800) Frozen plasma administration (OPS 8.812.6-8.812.8) Prothrombin concentrate administration (OPS 8-812.5) Fibrinogen administration (OPS 8-810.j) mechanical autotransfusion (OPS 8-803.2-3) Other blood products
Conditions
Interventions
Group 1: Prospective observation and analysis of all patients who have received or donated a blood product.
Sponsors
Goethe Universität Frankfurt, Universitätsklinikum, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? All individuals voluntarily donating blood, which includes the donation of red blood cells, thrombocytes, plasma, cryoplasma, and coagulation factors ? All persons who receive blood products, i.e. outpatients and inpatients who receive any quantity and type of blood products derived from human blood donors (red blood cells, platelets, plasma, cryoplasma, and coagulation factors of human origin and/or medication impacting in any way on the bone marrow (e.g. erythropoietin, iron formulations, platelet-releasing drugs, and other) ? All donors/recipients willing to give their informed consent for the study ? Any individuals that cannot give their consent can be included if someone has been granted medical power of attorney, and can consent for them ? Participants under 18 years can be included if their legal guardian(s) give(s) consent ? The coverage of the LOS Registry includes participants donating or receiving a single blood product or more and/or coagulation factors of human origin or medication impacting in any way on the bone marrow ? Registration can take place at any point in the treatment process, but must ensure that all diagnosed adverse events are recorded
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The registry study aims to determine any long-term effects associated with receiving and donating blood: ? First blood donation/transfusion captured by the LOS Registry ? Presentation of immediate adverse effects linked to blood transfusion/donation ? Long-term health status changes (new diagnoses, intervention, or treatment) based on annual follow-ups for 30 years since enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| Long-term goals of LOS according to the study plan ? Determine the impact of blood reception/donation on long-term health outcomes ? Adapt appropriate modes of long-term observation (quality of life observations, medical status observations, etc.) ? Identification of factors to predict “favourable” or “unfavourable” outcomes and development of precision medicine concepts in the field of blood transfusion ? Evaluation of the quality of care at the level of the participating centres (benchmarking) with the goal of quality improvement ? Develop and introduce quality assurance measures to the participating centres ? Develop national and international transfusion guidelines and elaborate position papers ? Determine quality indicators based on the pathophysiological findings and the clinical treatment approaches for the long-term course ? Promotion of international collaboration through standardisation ? Improved digitization of clinics and collaboration across Europe through data exchange ? Cooperation with other (inter)national registries to simplify data entry and to generate a larger data pool representative for diverse populations ? Preparation of information for dissemination among professionals, patients, and other stakeholders, including seminars and continuing medical education for physicians involved in all aspects of blood transfusions ? Determining if any new medical conditions arising in the course of the study are independently associated with receiving and/or donating blood ? Development, refinement, and continued testing of machine learning-based models for risk assessment, patient stratification and treatment | — |
Countries
Germany
Contacts
Public ContactElina Nürenberg-Goloub
Goethe Universität Frankfurt, Universitätsklinikum, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Outcome results
None listed