Guidelines for the Management of Severe Traumatic Brain Injury

Guidelines for the Management of Severe Traumatic Brain Injury

4th Edition

Nancy Carney, PhD Annette M. Totten, PhD Cindy O'Reilly, BS Jamie S. Ullman, MD Gregory W. J. Hawryluk, MD, PhD Michael J. Bell, MD Susan L. Bratton, MD Randall Chesnut, MD Odette A. Harris, MD, MPH Niranjan Kissoon, MD Andres M. Rubiano, MD

Lori Shutter, MD Robert C. Tasker, MBBS, MD

Monica S. Vavilala, MD Jack Wilberger, MD David W. Wright, MD Jamshid Ghajar, MD, PhD

Oregon Health & Science University, Portland, OR Oregon Health & Science University, Portland, OR Oregon Health & Science University, Portland, OR Hofstra North Shore-LIJ School of Medicine, Hempstead, NY University of Utah, Salt Lake City, UT University of Pittsburgh, Pittsburgh, PA University of Utah, Salt Lake City, UT University of Washington, Seattle, WA Stanford University, Stanford, CA University of British Columbia, Vancouver, BC El Bosque University, Bogota, Colombia; MEDITECH

Foundation, Neiva, Colombia University of Pittsburgh, Pittsburgh, PA Harvard Medical School & Boston Children's Hospital,

Boston, MA University of Washington, Seattle, WA Drexel University, Pittsburgh, PA Emory University, Atlanta, GA Stanford University, Stanford, CA

Reviewed for evidence-based integrity and endorsed by the American Association of Neurological Surgeons and the Congress of Neurological Surgeons.

September 2016

TABLE OF CONTENTS

PREFACE...................................................................................................................................... 5

ACKNOWLEDGEMENTS ..............................................................................................................................................5 FUNDING SOURCE......................................................................................................................................................6 DISCLAIMER OF LIABILITY ........................................................................................................................................6 CONFLICT OF INTEREST DISCLOSURE ........................................................................................................................7 AUTHORS' PREFACE ..................................................................................................................................................7

INTRODUCTION......................................................................................................................... 8

BRAIN TRAUMA RESEARCH: CURRENT CONDITIONS.................................................................................................8 THE BRAIN TRAUMA FOUNDATION'S POSITION ........................................................................................................9 THE BRAIN TRAUMA EVIDENCE-BASED CONSORTIUM............................................................................................12

METHODS .................................................................................................................................. 14

SYSTEMATIC EVIDENCE REVIEW AND SYNTHESIS ...................................................................................................14 DEVELOPMENT OF RECOMMENDATIONS..................................................................................................................22

EVIDENCE SYNTHESIS AND RECOMMENDATIONS, PART I: TREATMENTS....... 25

1. DECOMPRESSIVE CRANIECTOMY ...................................................................................................................26 2. PROPHYLACTIC HYPOTHERMIA......................................................................................................................36 3. HYPEROSMOLAR THERAPY ............................................................................................................................49 4. CEREBROSPINAL FLUID DRAINAGE ................................................................................................................57 5. VENTILATION THERAPIES ..............................................................................................................................62 6. ANESTHETICS, ANALGESICS, AND SEDATIVES ...............................................................................................67 7. STEROIDS .......................................................................................................................................................76 8. NUTRITION.....................................................................................................................................................84 9. INFECTION PROPHYLAXIS...............................................................................................................................99 10. DEEP VEIN THROMBOSIS PROPHYLAXIS ......................................................................................................111 11. SEIZURE PROPHYLAXIS ................................................................................................................................120

EVIDENCE SYNTHESIS AND RECOMMENDATIONS, PART II: MONITORING ... 130

12. INTRACRANIAL PRESSURE MONITORING......................................................................................................132 13. CEREBRAL PERFUSION PRESSURE MONITORING ..........................................................................................145 14. ADVANCED CEREBRAL MONITORING ..........................................................................................................151

EVIDENCE SYNTHESIS AND RECOMMENDATIONS, PART III: THRESHOLDS .. 163

15. BLOOD PRESSURE THRESHOLDS ..................................................................................................................164 16. INTRACRANIAL PRESSURE THRESHOLDS......................................................................................................172 17. CEREBRAL PERFUSION PRESSURE THRESHOLDS ..........................................................................................181 18. ADVANCED CEREBRAL MONITORING THRESHOLDS.....................................................................................191

FUTURE RESEARCH ............................................................................................................. 201

TOPIC SELECTION AND REFINEMENT.....................................................................................................................201 METHODS--INDIVIDUAL STUDIES.........................................................................................................................202 METHODS--SYSTEMATIC REVIEWS AND GUIDELINES DEVELOPMENT..................................................................203

CONCLUSION ......................................................................................................................... 205

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TABLES

TABLE 1-1. QUALITY OF THE BODY OF EVIDENCE (DEPRESSIVE CRANIECTOMY) ...................................................28 TABLE 1-2. SUMMARY OF EVIDENCE ? CLASS 1 AND 2 STUDIES (DEPRESSIVE CRANIECTOMY)..............................29 TABLE 1-3. SUMMARY OF EVIDENCE ? CLASS 3 STUDIES (DEPRESSIVE CRANIECTOMY) ........................................31 TABLE 2-1. QUALITY OF THE BODY OF EVIDENCE (PROPHYLACTIC HYPOTHERMIA) ..............................................37 TABLE 2-2. SUMMARY OF EVIDENCE ? CLASS 1 AND 2 STUDIES (PROPHYLACTIC HYPOTHERMIA) .........................39 TABLE 2-3. SUMMARY OF EVIDENCE?CLASS 3 STUDIES (PROPHYLACTIC HYPOTHERMIA) .....................................44 TABLE 3-1. QUALITY OF THE BODY OF EVIDENCE (HYPEROSMOLAR THERAPY) .....................................................51 TABLE 3-2. SUMMARY OF EVIDENCE - CLASS 2 (HYPEROSMOLAR THERAPY).........................................................52 TABLE 3-3. SUMMARY OF EVIDENCE?CLASS 3 STUDIES (HYPEROSMOLAR THERAPY) ...........................................54 TABLE 4-1. QUALITY OF THE BODY OF EVIDENCE (CEREBROSPINAL FLUID DRAINAGE).........................................58 TABLE 4-2. SUMMARY OF EVIDENCE ? CLASS 3 STUDIES (CEREBROSPINAL FLUID DRAINAGE) .............................59 TABLE 5-1. QUALITY OF THE BODY OF EVIDENCE (VENTILATION THERAPIES) .......................................................64 TABLE 5-2. SUMMARY OF EVIDENCE (VENTILATION THERAPIES) ...........................................................................65 TABLE 6-1. QUALITY OF THE BODY OF EVIDENCE (ANESTHETICS, ANALGESICS, AND SEDATIVES) ........................69 TABLE 6-2. SUMMARY OF EVIDENCE: CLASS 2 STUDIES (ANESTHETICS, ANALGESICS, AND SEDATIVES)...............70 TABLE 6-3. SUMMARY OF EVIDENCE: CLASS 3 STUDIES (ANESTHETICS, ANALGESICS, AND SEDATIVES)...............72 TABLE 7-1. QUALITY OF THE BODY OF EVIDENCE (STEROIDS)................................................................................77 TABLE 7-2. SUMMARY OF EVIDENCE: CLASS 1 AND 2 STUDIES (STEROIDS) ............................................................78 TABLE 7-3. SUMMARY OF EVIDENCE: CLASS 3 STUDIES (STEROIDS) ......................................................................81 TABLE 8-1. QUALITY OF THE BODY OF EVIDENCE (NUTRITION) .............................................................................86 TABLE 8-2. SUMMARY OF EVIDENCE: CLASS 2 STUDIES (NUTRITION) ....................................................................87 TABLE 8-3. SUMMARY OF EVIDENCE: CLASS 3 STUDIES (NUTRITION) ....................................................................91 TABLE 9-1. QUALITY OF THE BODY OF EVIDENCE (INFECTION PROPHYLAXIS) .....................................................101 TABLE 9-2. SUMMARY OF EVIDENCE: CLASS 2 STUDIES AND META-ANALYSES (INFECTION PROPHYLAXIS) .......103 TABLE 9-3. SUMMARY OF EVIDENCE: CLASS 3 STUDIES (INFECTION PROPHYLAXIS)............................................107 TABLE 10-1. QUALITY OF BODY OF EVIDENCE (DEEP VEIN THROMBOSIS PROPHYLAXIS) ....................................113 TABLE 10-2. SUMMARY OF EVIDENCE ? CLASS 3 STUDIES (DEEP VEIN THROMBOSIS PROPHYLAXIS) ..................114 TABLE 11-1. QUALITY OF BODY OF EVIDENCE (SEIZURE PROPHYLAXIS)..............................................................122 TABLE 11-2. SUMMARY OF EVIDENCE ? CLASS 2 STUDIES (SEIZURE PROPHYLAXIS)............................................123 TABLE 11-3. SUMMARY OF EVIDENCE ? CLASS 3 STUDIES (SEIZURE PROPHYLAXIS)............................................126 TABLE 12-1. QUALITY OF THE BODY OF EVIDENCE (INTRACRANIAL PRESSURE MONITORING) ............................134 TABLE 12-2. SUMMARY OF EVIDENCE: CLASS 1 AND 2 STUDIES (INTRACRANIAL PRESSURE MONITORING).........135 TABLE 12-3. SUMMARY OF EVIDENCE ? CLASS 3 STUDIES (INTRACRANIAL PRESSURE MONITORING) .................140 TABLE 13-1. QUALITY OF THE BODY OF EVIDENCE (CEREBRAL PERFUSION PRESSURE MONITORING) .................146 TABLE 13-2. SUMMARY OF EVIDENCE ? CLASS 2 STUDY (CEREBRAL PERFUSION PRESSURE MONITORING) ........147 TABLE 13-3. SUMMARY OF EVIDENCE ? CLASS 3 STUDIES (CEREBRAL PERFUSION PRESSURE MONITORING)......148 TABLE 14-1. QUALITY OF THE BODY OF EVIDENCE (ADVANCED CEREBRAL MONITORING) .................................153 TABLE 14-2. SUMMARY OF EVIDENCE: CLASS 2 STUDY (ADVANCED CEREBRAL MONITORING) ..........................154 TABLE 14-3. SUMMARY OF EVIDENCE ? CLASS 3 STUDIES (ADVANCED CEREBRAL MONITORING) ......................155 TABLE 15-1. QUALITY OF THE BODY OF EVIDENCE (BLOOD PRESSURE THRESHOLDS) .........................................165 TABLE 15-2. SUMMARY OF EVIDENCE ? CLASS 2 STUDY (BLOOD PRESSURE THRESHOLDS) ................................166 TABLE 15-3. SUMMARY OF EVIDENCE ? CLASS 3 STUDIES (BLOOD PRESSURE THRESHOLDS) ..............................167 TABLE 16-1. QUALITY OF THE BODY OF EVIDENCE (INTRACRANIAL PRESSURE THRESHOLDS) ............................174 TABLE 16-2. SUMMARY OF EVIDENCE ? CLASS 2 STUDY (INTRACRANIAL PRESSURE THRESHOLDS)....................175 TABLE 16-3. SUMMARY OF EVIDENCE ? CLASS 3 STUDIES (INTRACRANIAL PRESSURE THRESHOLDS) .................176 TABLE 17-1. QUALITY OF THE BODY OF EVIDENCE (CEREBRAL PERFUSION PRESSURE THRESHOLDS) .................183 TABLE 17-2. SUMMARY OF EVIDENCE ? CLASS 2 STUDIES (CEREBRAL PERFUSION PRESSURE THRESHOLDS) ......184 TABLE 17-3. SUMMARY OF EVIDENCE ? CLASS 3 STUDIES (CEREBRAL PERFUSION PRESSURE THRESHOLDS) ......185 TABLE 18-1. QUALITY OF THE BODY OF EVIDENCE (ADVANCED CEREBRAL MONITORING THRESHOLDS) ...........192 TABLE 18-2. SUMMARY OF EVIDENCE: CLASS 2 STUDIES (ADVANCED CEREBRAL MONITORING THRESHOLDS)..194 TABLE 18-3: SUMMARY OF EVIDENCE: CLASS 3 STUDIES (ADVANCED CEREBRAL MONITORING THRESHOLDS)..195

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APPENDICES

APPENDIX A. MAJOR CHANGES FROM 3RD TO 4TH EDITION ......................................................................................207 APPENDIX B. RESEARCH TEAM ..................................................................................................................................210 APPENDIX C. ANALYTIC FRAMEWORKS .....................................................................................................................211 APPENDIX D. SEARCH STRATEGIES ............................................................................................................................215 APPENDIX E. INCLUSION AND EXCLUSION CRITERIA .................................................................................................223 APPENDIX F. EXCLUDED STUDIES ..............................................................................................................................225 APPENDIX G. CRITERIA FOR QUALITY ASSESSMENT OF INDIVIDUAL STUDIES ...........................................................240 APPENDIX H. QUALITY OF THE BODY OF EVIDENCE ASSESSMENT.............................................................................242 APPENDIX I. HYPOTHERMIA INTERVENTIONS DETAIL ................................................................................................244

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Preface

Acknowledgements

We would like to thank the following people at the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University for their invaluable assistance in producing this document: Molly Stillwell, MA, Ngoc Wasson, MPH, Sandra Assasnik, MA, Elaine Graham, MLS, Leah Williams, BS, and Roger Chou, MD; we also thank Stephanie A. Kolakowsky-Hayner, PhD, and Meredith Klein, MS, from the Brain Trauma Foundation for their review of the document.

Additionally, we would like to thank the following people for serving as peer reviewers and providing their insights, comments, and suggestions: Mary Kay Bader, RN, Neuroscience Nurse's Association; Mission Hospital, Mission Viejo, CA Ross Bullock, MD, PhD, Medical Advisory Board, Brain Trauma Foundation; University of

Miami, Miami, FL Jamie Cooper, MD, Australian and New Zealand Intensive Care Research Centre, Monash

University, Melbourne, Victoria, Australia Chris Cribari, MD, American College of Surgeons Committee on Trauma; University of

Colorado, Boulder, CO Rachel Groman, MPH, Quality Improvement and Research, American Association of

Neurological Surgeons/Congress of Neurological Surgeons, Washington, DC Karen Hirsch, MD, Neurology, Stanford School of Medicine, Palo Alto, CA Stephan Mayer, MD, Neurocritical Care Society; Mount Sinai, New York, NY Enrique No?, MD, PhD, Neurology, Hospital NISA, Valecnia al Mar and Sevilla-Aljarafe, Spain Gustavo Petroni, MD, Hospital de Emergencias Dr. Clemente Alvarez, Rosario, Santa Fe,

Argentina P.B. Raksin, MD, Neurosurgery, John H. Stroger Jr. Hospital of Cook County, Chicago, IL, Gerard Ribbers, MD, PhD, Rehabilitation Medicine, Erasmus University of Rotterdam,

Rotterdam, Netherlands

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Alex Valadka, MD, American Association of Neurological Surgeons; National Trauma Institute; Seton Brain and Spine Institute, Austin, TX (presently at Virginia Commonwealth University, Richmond, VA) Finally, we would like to recognize the American Association of Neurological Surgeons

(AANS) and the Congress of Neurological Surgeons (CNS) Joint Guidelines Committee (JGC) for providing feedback on the Guidelines for the Management of Severe Traumatic Brain Injury, 4th Edition, and the AANS and CNS leadership for their endorsement, which appears on the title page.

Funding Source

This material is based in part upon work supported by (1) the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division, through a contract awarded to Stanford University (W911 QY-14-C-0086), a subcontract awarded to the Brain Trauma Foundation, and a second-tier subcontract awarded to Oregon Health & Science University and (2) the Brain Trauma Foundation, through a contract awarded to Oregon Health & Science University.

Any opinions, findings and conclusions or recommendations expressed in this material are those of the authors and do not necessarily reflect the views of the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division, Stanford University, or the Brain Trauma Foundation.

Disclaimer of Liability

The information contained in the Guidelines for the Management of Severe Traumatic Brain Injury reflects the current state of knowledge at the time of publication. The Brain Trauma Foundation, American Association of Neurological Surgeons, Congress of Neurological Surgeons, and other collaborating organizations are not engaged in rendering professional medical services and assume no responsibility for patient outcomes resulting from application of these general recommendations in specific patient circumstances. Accordingly, the Brain Trauma Foundation, American Association of Neurological Surgeons, and Congress of Neurological Surgeons consider adherence to these clinical practice guidelines will not necessarily assure a

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successful medical outcome. The information contained in these guidelines reflects published scientific evidence at the time of completion of the guidelines and cannot anticipate subsequent findings and/or additional evidence, and therefore should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same result. Medical advice and decisions are appropriately made only by a competent and licensed physician who must make decisions in light of all the facts and circumstances in each individual and particular case and on the basis of availability of resources and expertise. Guidelines are not intended to supplant physician judgment with respect to particular patients or special clinical situations and are not a substitute for physician-patient consultation. Accordingly, the Brain Trauma Foundation, American Association of Neurological Surgeons, and Congress of Neurological Surgeons consider adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in light of each patient's individual circumstances.

Conflict of Interest Disclosure

There are no conflicts of interest. The authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this publication.

Authors' Preface

The scope and purpose of this work is two-fold: to synthesize the available evidence and to translate it into recommendations. This document provides recommendations only when there is evidence to support them. As such, they do not constitute a complete protocol for clinical use. Our intention is that these recommendations be used by others to develop treatment protocols, which necessarily need to incorporate consensus and clinical judgment in areas where current evidence is lacking or insufficient. We believe it is important to have evidence-based recommendations in order to clarify what aspects of practice currently can and cannot be supported by evidence, to encourage use of evidence-based treatments that exist, and to encourage creativity in treatment and research in areas where evidence does not exist. The communities of neurosurgery and neuro-intensive care have been early pioneers and supporters of evidence-based medicine and plan to continue in this endeavor.

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Guidelines for the Management of Severe Traumatic Brain Injury

Introduction

In this 4th Edition of the Brain Trauma Foundation's guidelines, there are 189 publications used for evidence--5 Class 1, 46 Class 2, 136 Class 3 studies, and 2 meta-analyses. Over the past 20 years, our community has evolved along with the science and application of evidencebased medicine in general. As a consequence, with each new iteration of the guidelines, we have applied the most current methodological standards and established more rigorous procedures for future work. This approach resulted in changes in the evaluation of previous work, an increase in the quality of the included studies, and essential improvements in the precision of the recommendations.

The size of the literature base is a reflection of the rate at which new studies are being conducted that can be used as evidence for guideline recommendations. During the 7 years between the 3rd1 and 4th Editions of this work, 94 new studies were added to the library of evidence. Although there have been numerous new publications, many of them repeat the same methodological flaws found in previous research. The following is an examination of the current condition of brain trauma clinical research, our view of how this condition is defining and shaping our future, and a proposed solution in establishing a formal evidence-based consortium.

Brain Trauma Research: Current Conditions

Clinical Trials in TBI. Failure to establish intervention effectiveness for brain trauma in clinical trials is a primary feature of the current condition of our work. Fourteen years ago, the Clinical Trials in Head Injury Study Group published a thoughtful summary of recommendations to improve the design and conduct of clinical trials in TBI.2 They encouraged (in part):

? Identification and testing of specific (appropriate) subgroups of TBI patients ? Standardized clinical management across centers ? Independent monitoring of patient management and data quality

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