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Basics of Blood Management Basics of Blood Management Second edition Petra Seeber MD Institute for Blood Management Gotha, Germany Aryeh Shander MD, FCCM, FCCP Chief of Anesthesiology, Critical Care Medicine and Hyperbaric Medicine Englewood Hospital and Medical Center Englewood, NJ, USA; Clinical Professor of Anesthesiology, Medicine and Surgery Mount Sinai School of Medicine Mount Sinai Hospital New York, NY, USA A John Wiley & Sons, Ltd., Publication This edition fi rst published 2013 © 2007, 2013 by John Wiley & Sons, Ltd. Wiley-Blackwell is an imprint of John Wiley & Sons, formed by the merger of Wiley’s global Scientifi c, Technical and Medical business with Blackwell Publishing. Registered offi ce: John Wiley & Sons, Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK Editorial offi ces: 9600 Garsington Road, Oxford, OX4 2DQ, UK The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK 111 River Street, Hoboken, NJ 07030-5774, USA For details of our global editorial offi ces, for customer services and for information about how to apply for permission to reuse the copyright material in this book please see our website at www.wiley.com/ wiley-blackwell The right of the author to be identifi ed as the author of this work has been asserted in accordance with the UK Copyright, Designs and Patents Act 1988. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher. Designations used by companies to distinguish their products are often claimed as trademarks. All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners. The publisher is not associated with any product or vendor mentioned in this book. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is sold on the understanding that the publisher is not engaged in rendering professional services. If professional advice or other expert assistance is required, the services of a competent professional should be sought. The contents of this work are intended to further general scientifi c research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting a specifi c method, diagnosis, or treatment by physicians for any particular patient. The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifi cally disclaim all warranties, including without limitation any implied warranties of fi tness for a particular purpose. In view of ongoing research, equipment modifi cations, changes in governmental regulations, and the constant fl ow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. Readers should consult with a specialist where appropriate. The fact that an organization or Website is referred to in this work as a citation and/or a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make. Further, readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read. No warranty may be created or extended by any promotional statements for this work. Neither the publisher nor the author shall be liable for any damages arising herefrom. Library of Congress Cataloging-in-Publication Data Seeber, Petra. Basics of blood management / Petra Seeber, Aryeh Shander. – 2nd ed. p. cm. Includes bibliographical references and index. ISBN 978-0-470-67070-5 (pbk. : alk. paper) 1. Transfusion-free surgery. 2. Blood– Transfusion. 3. Blood banks. I. Shander, Aryeh. II. Title. RD33.35.S44 2013 362.17'84–dc23 2012014993 A catalogue record for this book is available from the British Library. Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books. Cover image: Top: left / right; bottom: left Stefano Lunardi / Kzenon / jpa1999. Bottom: right Petra Seeber Cover design: Steve Thompson Set in 9.25/11.5 pt Minion by Toppan Best-set Premedia Limited 1 2013 Contents Preface, vii Preface to the First Edition, viii 1 History and Organization of Blood Management, 1 2 Physiology of Anemia and Oxygen Transport, 9 3 Anemia Therapy I: Erythropoiesis-Stimulating Agents, 21 4 Anemia Therapy II: Hematinics, 36 5 Growth Factors, 51 6 Fluid Management, 67 7 Chemistry of Hemostasis, 81 8 Recombinant Blood Products, 100 9 Artifi cial Blood, 109 10 Oxygen Therapy, 124 11 Preparation of the Patient for Surgery, 139 12 Iatrogenic Blood Loss, 160 13 Physical Methods of Hemostasis, 173 14 Anesthesia—More than Sleeping, 191 15 Use of Autologous Blood, 201 16 Cell Salvage, 212 17 Blood-Derived Pharmaceuticals, 229 18 Transfusion Medicine, 245 19 Step by Step to an Organized Blood Management Program, 262 20 Law, Ethics, Religion, and Blood Management, 285 v vi Contents Appendix A: Detailed Information, 297 Appendix B: Sources of Information for Blood Management, 305 Appendix C: Program Tools and Forms, 309 Appendix D: Teaching Aids: Research and Projects, 323 Index, 327 Preface Much has been done in blood management since the fi rst specialty, from neonatology to geriatrics, from anesthesi- edition. This is not only true for the many scientifi c ology to urology, and including all clinical specialties as studies that elevate blood management out of the low well as laboratory - based specialties such as diagnostic plains of experience - driven action into the realms of laboratory medicine, can contribute to a successful blood evidence - based medicine. Many of the things that blood management program. managers over the decades have observed have now been As in the fi rst edition, the book introduces the reader proven in randomized clinical trials. Other things in to blood management and explains how to improve blood management that may have been driven by tradi- medical outcomes by avoiding undue blood loss, enhanc- tion and belief have come into question. These develop- ing the patient ’ s own blood, and improving tolerance of ments contribute greatly to the maturation of this new anemia and coagulopathy until any of the underlying specialty of blood management. conditions are successfully remedied. While the fi rst It is interesting, though, to note that the defi nition of edition considered transfusion avoidance as a very blood management is still not accepted by all who claim important outcome improvement, the second edition to practice blood management. Some use the term blood shifts its focus from this aspect of improving outcomes management to effi ciently distribute the ever more scarce to the even more important reduction of morbidity and resource of banked blood to those patients who are mortality. This does not mean that transfusion avoidance deemed to be in the greatest need. Others consider blood is not a noble goal. But it means that – lacking good (sci- management as the outcome - oriented part of transfusion entifi c) reasons to transfuse – there is no point in trying to medicine that delivers allogeneic blood products in an avoid something that has no proven value in itself. It evidence - based manner. Still others see blood manage- should be self - evident that such non - proven therapies ment as a mix of transfusion medicine and hematology. should be let go. Mounting evidence shows that the out- And another group of medical practitioners consider comes of patients treated by current principles of trans- blood management to be a religiously motivated restric- fusion medicine are not superior to those obtained in tion of modern medicine. However, blood management transfusion - free environments, and that in some sub- is none of these. At the core of blood management are groups even the contrary might be the case. Therefore, it two foci: one is the patient ’ s own blood as a precious, seems timely to advance patient care beyond this point live - saving, and potentially fi nite resource; and the other and focus attention on interventions that have proven is the patient ’ s outcome. To manage the patient ’ s resource value in improving patient outcome. We therefore again “ blood” skillfully to optimize his or her outcome is the invite you cordially to continue your efforts to improve philosophy that drives blood management. your patient ’ s outcome by optimal blood management. Practically speaking, blood management is a multidis- ciplinary, multimodality concept that focuses on the Petra Seeber and Aryeh Shander patient by improving his/her outcome. Every medical March 2012 vii Preface to the First Edition The benefi t - to - risk ratio of blood products needs con- reader to blood management and explains how to stant evaluation. Blood products, as therapeutic agents, improve medical outcomes by avoiding undue blood loss, have had the test of time but still lack the evidence we enhancing the patient ’ s own blood, and improving toler- expect from other medicinals. Blood, an organ, is used as ance of anemia and coagulopathy until any of these a pharmaceutical agent by the medical profession, due to underlying conditions are successfully remedied. the achievements in collection, processing, banking, and This introduction to blood management is intended distribution. The fact that the most common risk of for training and early practicing clinicians. It is meant to blood transfusion is blood delivery error supports the be both informative and practical, and spans many of the notion that blood must be handled as a pharmaceutical medical specialties that encounter blood and transfusions agent. Over the last few decades, the risk of blood transfu- as part of their daily practice. It will aid in tailoring indi- sion and associated complications has raised concerns vidual care plans for different patients. Finally, it addresses about the safety of blood by both the public and health- the structure and function of a blood management care providers. At the same time, experience with patients program, a novel approach to blood conservation, and refusing blood and data on blood conservation have improved patient outcome. brought to light the real possibility of other modalities to In this book, blood management is considered from an treat perisurgical anemia and to avoid it with blood con- international perspective, so attention is paid to condi- servation methods. In addition to risks and complica- tions encountered in developing as well as industrial tions, data have become available that demonstrate the countries. Techniques such as cell salvage are performed behavioral aspect of transfusion practice versus an evi- differently in economically deprived countries; HIV, hep- dence - based practice. In this book, we address many atitis, and malaria may or may not be a threat to the blood aspects of modern transfusion medicine, known blood supply, depending on geographical location; oxygen, conservation modalities, and new approaches to the intravenous fl uids, and erythropoiesis - stimulating pro- treatment of perisurgical anemia, as well as special clini- teins may be readily available in some countries or inac- cal considerations. This approach, now termed “ blood cessible in others. The book is intended to broaden the management ” by the Society for the Advancement of readers′ horizons, discussing working conditions encoun- Blood Management (SABM, www.sabm.org), incorpo- tered by blood managers around the world. Many of the rates appropriate transfusion practice and blood conser- clinical scenarios and the exercises that follow are vation to deliver the lowest risk and highest benefi t to the intended to allow the reader to adapt the information to patient. In addition, it brings all these modalities to the the prevailing circumstances in their location. patient ’s bedside and above all is a patient - centered This book is unique in the fact that it is the fi rst dedi- approach. Blood management is a multidisciplinary, cated in its entirety to the concept of blood management. multimodality concept that focuses on the patient. The authors hope that this book will stimulate its readers Patient outcome is improved, making this one of the to further advance blood management through shared most intriguing and rewarding fi elds in medicine. experience and research. It is intended to be informative, Blood management requires an understanding of all practical, enjoyable, and hopefully will stimulate debate elements of blood and transfusions. It includes the phi- and discussion as well as help patients in need. losophy, biology, physiology, and ethical considerations, as well as demonstrating the practical application of Petra Seeber and Aryeh Shander various techniques. This publication introduces the March 2007 viii 1 History and Organization of Blood Management B lood management has evolved from humble beginnings Transfusion - free medicine and surgery: Since “ bloodless into a viable, rapidly - developing medical specialty. Its medicine ” is something of a misnomer, the term development was initiated by the wish of Jehovah ’ s Wit- “ transfusion - free medicine ” was coined and is used nesses for a transfusion - free treatment and has been instead. shaped by infl uences coming from transfusion medicine Blood conservation: “ Blood conservation is a global and the military ’ s experiences. Blood management has concept engulfi ng all possible strategies aimed at reducing today been introduced into mainstream medicine. The patient ’ s exposure to allogeneic blood products ” [1] . This vivid history of blood management is described in this concept does not exclude the use of allogeneic blood chapter. entirely. Blood management: Blood management is the philoso- phy to improve patient outcomes by caring for and man- Objectives aging the patient ’ s own blood as a precious, life - saving resource. It is a patient - centered, multidisciplinary, mul- 1. To identify the historical developments that have led timodal, planned approach to patient care. Blood man- to today ’ s concept of blood management. agement is not an “ alternative ” to allogeneic transfusions; 2. To demonstrate the benefi ts of blood management. it is the standard of care. 3. To identify blood management as “ good clinical ” Patient blood management: In order to clarify that practice. blood management is not confused with an outcome - 4. To show that blood management and its techniques oriented transfusion therapy, the term “ patient ” is added, should be used in all cases who qualify. denoting that it is not the blood in the blood bank that 5. To help understand how a blood management program is managed but the patient ’ s own blood that is taken good works. care of and managed in accord with the philosophy of blood management. Defi nitions A brief history Bloodless medicine and surgery: Bloodless medicine is a multimodality, multidisciplinary approach to safe and Bloodless medicine, transfusion-free effective patient care without the use of allogeneic blood medicine, blood conservation, and products. Bloodless medicine and surgery utilize phar- blood management macological and technological means as well as medical The term “ bloodless medicine ” is often associated with and surgical techniques to provide the best possible care the belief of Jehovah ’ s Witnesses that they should refrain without the use of donor blood. from the use of blood, therefore ruling out the option of Basics of Blood Management, Second Edition. Petra Seeber and Aryeh Shander. © 2013 John Wiley & Sons, Ltd. Published 2013 by John Wiley & Sons, Ltd. 1 2 Chapter 1 blood transfusion. The essence of bloodless medicine, the use of blood transfusions. These were in fact the and lately, blood management, however, is not restricted earliest blood managers. As their experience in perform- to the beliefs of a religious group. To get a better under- ing “ bloodless ” surgery increased, more complex proce- standing as to what bloodless medicine and blood man- dures, such as open heart surgery, orthopedic surgery, agement mean, let us go back to the roots of these and cancer surgery, could be performed. Even children disciplines. and newborns could successfully be treated without One is not completely wrong to attribute the origin of transfusing blood. Before long, these pioneering physi- the term “ bloodless medicine ” to the endeavor of cians published their results with Witness patients, Jehovah ’ s Witnesses to receive treatment without resort- thereby encouraging other doctors to adopt the methods ing to donor blood transfusion. Their attitude toward the used in performing such surgical interventions. sanctity of blood greatly infl uences their view of blood Among the fi rst to rise to the challenge was the heart transfusion. This was described as early as 1927 in their surgeon Denton Cooley of Texas. In the early 1960s, his journal The Watchtower (December 15, 1927). Although team devised methods to treat Witness patients. He the decision to refuse blood transfusion is a completely described the techniques in an article, “ Open heart religious one, the Witnesses have frequently used scien- surgery in Jehovah ’ s Witnesses, ” published in 1964 in T he tifi c information about the side effects of donor blood American Journal of Cardiology . In 1977, Cooley reported transfusion to convince their physicians that their deci- his experiences with more than 500 patients [2] . sion is a reasonable one and is corroborated by scientifi c Cooley’ s example was followed by many other coura- evidence. The booklet entitled B lood, Medicine and the geous physicians. For instance, in 1970 Dr Pearce per- Law of God (published in 1961) explained the Witnesses ’ formed bloodless open heart surgery in New Orleans. His religious stand, but also addressed issues such as transfu- efforts did not go unnoticed. Newspapers reported on sion reactions, transfusion - related syphilis, malaria, and these spectacular cases. Perhaps out of curiosity or out of hepatitis. the earnest desire to learn, many colleagues visited Dr Refusing blood transfusions on religious grounds was Pearce ’ s team in the operating room to learn how to do not easy. Repeatedly, patients were physically forced to “ bloodless hearts. ” Jerome Kay, from Los Angeles, also take donor blood, using such high - handed methods as performed bloodless heart surgery. In 1973 he reported incapacitation by court order, strapping patients to the that he was now performing bloodless heart surgery on bed (even with the help of police offi cers), and secretly the majority of his patients. The call for bloodless treat- adding sedatives to a patient ’ s infusion. In the early 1960s, ments spread around the whole world. Sharad Pandey, of representatives of Jehovah ’ s Witnesses started visiting the KEM Hospital in Mumbai, India, adopted bloodless physicians to explain the reasons why transfusions were techniques from Canada and tailored them to Indian refused by the Witness population. They often offered conditions. Centers in Europe and the rest of the world literature that dealt with techniques that were acceptable started adopting these advances as well. to Witness patients, informing physicians of the availabil- It is understandable that Witness patients preferred to ity of so - called transfusion alternatives. In 1979 the gov- be treated by physicians who had proven their willingness erning body of the Jehovah ’ s Witnesses announced the and ability to treat them without using donor blood. The formation of Hospital Liaison Committees (see Chapter good reputation of such physicians spread and so patients 20 ). These continued to “ support Jehovah ’ s Witnesses in from far away were transferred to their facilities. This laid their determination to prevent their being given blood the foundation for organized “ bloodless programs. ” One transfusions, to clear away misunderstandings on the part of the hospitals with such a program was the Esperanza of doctors and hospitals, to establish a more cooperative Intercommunity Hospital in Yorba Linda, California, spirit between medical institutions and Witness patients where a high percentage of patients were Witnesses. Herk (our italics)” and to “ alert hospital staff to the fact that Hutchins, an experienced surgeon and a Witness himself, there are valid alternatives to the infusion of blood ” . was known for his development of an iron - containing Occasionally, the Witnesses even went to court to fi ght formula for blood - building. Among his team was the for their rights as patients. In a great number of cases, the young surgeon Ron Lapin, who was later famed for his Witnesses ’ position was upheld by the courts. pioneering work in the area of bloodless therapies. Critics Although many physicians had diffi culty with the labeled him a quack. Nevertheless, he continued and was concept of bloodless medicine, some took up the chal- later honored for opening one of the fi rst organized lenge to provide the best possible medical care without bloodless centers in the world, as well as for publishing History and Organization of Blood Management 3 the fi rst journal on this topic, and for his efforts to teach agement, but not on religious grounds. Instead, the his colleagues. During his career, he performed thousands military made many crucial contributions to blood man- of bloodless surgeries. agement by taking care of the thousands of wounded T he pioneers of blood management had to rise to the operated on before transfusions became feasible, thereby challenge of using and refi ning available techniques, actually performing “ bloodless surgery. ” It was on the adjusting them to current needs, and individualizing battlefi eld that hemorrhage was recognized as a cause of patient care. They adopted new technologies as soon as death. Therefore, it was imperative for military surgeons was reasonable. Much attention was paid to details of to stop hemorrhage promptly and effectively, and to patient care, thus improving the quality of the whole avoid further blood loss. To achieve this, many techniques therapy. They also fought for patients ’ rights and upheld of bloodless medicine and blood management were those rights. Many involved in the fi eld of blood manage- invented. The experience of the early surgeons serving ment confi rm the good feeling that comes from being near the battlefi eld is applicable in today ’ s blood manage- a physician in the truest sense. There is no need to force ment schemes. William Steward Halsted, a surgeon on the a particular treatment. Such an attitude is a precious her- battlefi eld, described uncontrolled hemorrhage [3] and itage from the pioneers of blood management. Now, at later taught his trainees at Johns Hopkins the technique the beginning of the 21st century, this pioneering spirit of gentle tissue handling, surgery that respects anatomy, can still be felt at some meetings dedicated to blood and meticulous hemostasis (Halstedian principles). His management. excellent work provides the basis of the surgical contribu- C urrently, strenuous efforts are being made to incor- tion to a blood management program. porate blood management further and deeper into Since war brought a deluge of hemorrhaging victims, mainstream medicine. This elicits various responses. there was a need for a therapy. As soon as transfusions Transfusionists, who are actually well suited to spearhead became practical, they were adopted by the military, but blood management, sometimes insist that their current experience from the First and Second World Wars also realm of activity defi nes blood management. However, showed their drawbacks, such as storage problems and transfusion medicine so far is a discipline in itself and transfusion - transmissible diseases. So, while the world defi nes only certain aspects of blood management, such wars propelled the development of transfusion medicine, as cell salvage or the rare provision of specifi c, purifi ed they simultaneously spurred the development of alterna- blood products, e.g., fi brinogen concentrates. Other tive treatments. Intravenous fl uids had been described in aspects of blood management include surgical tech- the earlier medical literature [4, 5] , but the pressing need niques, pharmacological hemostasis, diagnostic proce- to replace lost blood and the diffi culties involved in trans- dures, etc. At the core of blood management, however, is fusions provided a strong impetus for military medicine the patient ’ s own blood as a precious, life - saving com- to change its practice. In this connection, the following modity. To emphasize this further, recently the term comment in the P rovidence Sunday Journal of May 17, blood management has been replaced by the term patient 1953 is pertinent: “ The Army will henceforth use dextran, blood management by some groups. Although not all a substance made from sugar, instead of blood plasma, parties agree with the defi nition of blood management, for all requirements at home and overseas, it was learned the World Health Organization (WHO) endorsed blood last night. An authoritative Army medical source, who management as a specialty worth developing further. asked not to be quoted by name, said ‘ a complete switcho- During its 63rd World Health Assembly in 2010, the ver ’ to the plasma substitute has been put into effect, after WHO defi ned blood management as the previously pub- ‘ utterly convincing ’ tests of dextran in continental and lished three - pillar model (preoperative anemia manage- combat area hospitals during the last few months. This ment, reduction of blood loss, improvement of anemia offi cial said a major factor in the switchover to dextran tolerance). Although this model includes only one aspect was that use of plasma entails a ‘ high risk ’ of causing of blood management, the WHO ’ s endorsement repre- a disease known as serum hepatitis — a jaundice - like sents an important historical development. ailment. Not all plasma carries this hazard, he empha- sized, but he added that dextran is entirely free of the Military use of blood and hazard. ‘ We have begun to fi ll all orders from domestic blood management and overseas theaters with dextran instead of plasma. ’ ” Over the centuries, the armies of different nations have The military readily adopted other promising products contributed to the development of current blood man- in blood management. For example, the surgeon Gerald

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Content: Chapter 1 History and Organization of Blood Management (pages 1–8): Chapter 2 Physiology of Anemia and Oxygen Transport (pages 9–20): Chapter 3 Anemia Therapy I: Erythropoiesis?Stimulating Agents (pages 21–35): Chapter 4 Anemia Therapy II: Hematinics (pages 36–50): Chapter 5 Growth
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Most books are stored in the elastic cloud where traffic is expensive. For this reason, we have a limit on daily download.