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Germany Haemotherapy Guidelines

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Germany Haemotherapy Guidelines Bundesärztekammer (German Medical Association) Cross-sectional Guidelines for Therapy with Blood Components and Plasma Derivatives Published by: Executive Committee of the German Medical Association on the recommendation of the Scientific Advisory Board 4th revised edition ii Notice: Medical science and the public health service are subject to continuous development, entailing that all statements regarding them can only be in accordance with the state of knowledge current at the time of publication. The utmost care was taken by the authors in compiling and verifying the stated recommendations. Despite diligent manuscript preparation and proof-reading of the typeset, occasional mistakes cannot be ruled out with certainty. Regarding the choice and dosage of drugs, the reader is requested to consult the manufacturer’s package insert and expert information and, in case of doubt, to draw on a specialist. Liability for any diagnostic or therapeutic application, medication or dosage lies with the reader. Accordingly, the German Medical Association does not assume responsibility and no subsequent or any other damage that result in any way from the use of information contained in this publication. This publication is copyright-protected. Any unauthorized use therefore requires prior written permission from the German Medical Association. Copyright © 2009 by German Medical Association iii This English translation and printing of the Cross-sectional Guidelines was funded by the organisers of the European Symposium on “Optimal Clinical Use of Blood Components”, April 24th–25th 2009, Wildbad Kreuth, Germany (European Directorate for the Quality of Medicines & Health Care, Strasbourg; LMU Klinikum der Universität, München; Paul- Ehrlich-Institut, Langen). The organisers gratefully acknowledge the excellent translation by Ms. Ursula Erikli (Robert Koch-Institut, Berlin). iv Preface The appropriate handling of blood components for hemotherapy represents a particular challenge for medical practice. On the one hand, it is essential to optimally apply the blood products available by indicating their therapeutic administration responsibly and critically. On the other hand, because the blood products are a limited resource that was obtained by voluntary blood donations, it is mandatory to use them with particular care. According to articles 12 a and 18, the Transfusionsgesetz (TFG, German Transfusion Act) rules that the German Medical Association (GMA) determines the generally accepted current state of scientific knowledge in medicine and technology regarding the preparation of blood and blood components as well as their application by developing and publishing Guides. According to article 18 TFG, the German Guide for Hemotherapy contains rules and regulations for the administration of blood products. The present Cross-sectional Guidelines contain recommendations regarding the selection of blood components and plasma derivatives as well as their indication and therapeutic administration. In comparison to disease-oriented guidelines, these Cross-sectional Guidelines focus on the critical assessment of a multitude of hemato-therapeutic treatments. This particular character of the publication is expressed in its novel designation as Cross-sectional Guidelines (GMA). On compiling these Cross-sectional Guidelines, the editors felt the unchanged incentive to submit therapeutic principles and dosages derived predominantly from well-tried clinical experience to critical review and to revise them according to current scientific standards. Similar to the practice regarding the German Guide for Hemotherapy, the Scientific Advisory Board of the German Medical Association has appointed a Working Group, whose members specialize in diverse medical disciplines, to prepare appropriate recommendations. In particular, the present revision is endeavoring to draft practical guidance and to distinctly point out the respective state of scientific evidence. The editors thank the Medical Societies, organizations and public institutions for their essen- tial part in developing further these therapeutic recommendations through their statements in the context of the hearing procedure. In particular, we appreciate the methodological advice of the Ärztliche Zentrum für Qualität in der Medizin (ÄZQ, Agency for Quality in Medicine). Specials thanks go to the experts of the Standing Working Group of the Scientific Advisory Board “Guidelines for Hemotherapy” who volunteered their expertise and who through their extensive personal dedication have rendered this publication possible in the first place. To donate blood is an inestimable service of volunteers who contribute every day to help critically ill patients and to preserve life. It shall be particularly emphasized here that the entire medical fraternity is grateful for this service. The appreciation of such altruistic assistance makes it mandatory for all physicians to apply blood products responsibly. The “Cross-sectional Guidelines for Therapy with Blood Compo- nents and Plasma Derivatives” shall contribute towards this goal. Prof. Dr. med. Dr. h.c. J.-D. Hoppe President of the German Medical Association and of the German Medical Assembly Prof. Dr. med. Dr. h.c. P. C. Scriba Chairman of the Scientific Advisory Board of the German Medical Association Prof. Dr. med. H. Klüter Central Coordinator of the Standing Working Group “Guidelines for Hemotherapy” v Table of contents 0 General explanations 1 1 RBC concentrates 8 2 Platelet concentrates 23 3 Granulocyte concentrates 42 4 Plasma for therapeutical use 49 5 Human albumin 64 6 Factor VIII concentrates, factor VIII / von Willebrand factor 79 concentrates, factor IX concentrates, activated prothrombin complex concentrates 7 Procoagulants 96 8 Inhibitors 126 9 Human immunoglobulins 145 10 Autologous hemotherapy 165 11 Adverse reactions 174 Annex Legal rules regarding expert information (Summary of Product 199 Characteristics, SPC) on medical products List of Medical Societies, organizations and public institutions 201 participating in the hearing Members of the Working Group 203 Chapter 0 – General explanations 1 0 General explanations 0.1 Classification of these Cross-sectional Guidelines The present publication is called “Cross-sectional Guidelines (GMA)”, because recommenda- tions are given regarding the entire range of blood components and plasma derivatives the application of which represents a particular challenge for medical practice. On the one hand, it is essential to optimally apply the blood products available by indicating their therapeutic application responsibly and critically and to prevent risks like transmission of infections. On the other hand, because the blood products are a limited resource that was obtained by volun- tary blood donations, it is mandatory to use them with particular care. Because of this wide range of subjects, the Working Group chose to deviate from the usual practice in guidelines to refer to a single disease entity. The ambition regarding contents of the present publication corresponds to its special legal position since the present Cross-sectional Guidelines are referred to in the German Guide for Therapy with Blood Components and Plasma Derivatives (Hemotherapy) according to article 18 Transfusion Act (TFG). It is a result of the special character of these Cross-sectional Guidelines that the methodology used in its compilation is different from the one preferably used by Medical Societies in Ger- many in developing guidelines or the one used in compiling National Disease Management Guidelines. Regarding several issues, the Working Group has deliberately decided to deviate from the approach used in compiling evidence-based “S2” guidelines. Rather the focus of methodological procedure is on consensus processes that were tried and tested by the Scien- tific Advisory Board, in particular the comprehensive hearings of the Medical Societies con- cerned and circles of experts, respectively (see section 0.3). For these three reasons the present Cross-sectional Guidelines form a separate entity. 0.2 Classification of the recommendations Compared to previous editions, in the present revised edition the refinement of the Guidelines is further systemized. Initially the individual chapters were revised by the authors indicated and adapted to the present state of the art. In doing so the authors were requested to give defi- nite recommendations regarding the selection and indication for administration of a particular blood product and to classify them according to the principles of Evidence-based Medicine. On implementation of this classification system, the underlying evidence and the level of the recommendation is demonstrated to the user in a comprehensible manner. The assignation of quality categories to data and studies on which the recommendations are based followed the system developed for compiling the Guidelines of the American College of Chest Physicians (ACCP) regarding thrombosis prophylaxis and therapy (Guyatt et al 20041). The recommendations were marked as follows (see Table 1): 1 Guyatt G, Schunemann HJ, Cook D, Jaeschke R, Pauker S: Applying the grades of recommendation for antithrombotic and thrombolytic therapy: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126 (suppl 3): 179S-87S. 2 Chapter 0 – General explanations Designation of the level of recommendation Recommendations were marked as level 1 recommendation if, based on present data, the experts were convinced that in compliance to
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