Executive Summary: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE (PEACE) Consensus Conference.
Journal
Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies
ISSN: 1529-7535
Titre abrégé: Pediatr Crit Care Med
Pays: United States
ID NLM: 100954653
Informations de publication
Date de publication:
01 Jul 2024
01 Jul 2024
Historique:
medline:
3
7
2024
pubmed:
3
7
2024
entrez:
3
7
2024
Statut:
ppublish
Résumé
To present recommendations and consensus statements with supporting literature for the clinical management of neonates and children supported with extracorporeal membrane oxygenation (ECMO) from the Pediatric ECMO Anticoagulation CollaborativE (PEACE) consensus conference. Systematic review was performed using PubMed, Embase, and Cochrane Library (CENTRAL) databases from January 1988 to May 2021, followed by serial meetings of international, interprofessional experts in the management ECMO for critically ill children. The management of ECMO anticoagulation for critically ill children. Within each of eight subgroup, two authors reviewed all citations independently, with a third independent reviewer resolving any conflicts. A systematic review was conducted using MEDLINE, Embase, and Cochrane Library databases, from January 1988 to May 2021. Each panel developed evidence-based and, when evidence was insufficient, expert-based statements for the clinical management of anticoagulation for children supported with ECMO. These statements were reviewed and ratified by 48 PEACE experts. Consensus was obtained using the Research and Development/UCLA Appropriateness Method. Results were summarized using the Grading of Recommendations Assessment, Development, and Evaluation method. We developed 23 recommendations, 52 expert consensus statements, and 16 good practice statements covering the management of ECMO anticoagulation in three broad categories: general care and monitoring; perioperative care; and nonprocedural bleeding or thrombosis. Gaps in knowledge and research priorities were identified, along with three research focused good practice statements. The 91 statements focused on clinical care will form the basis for standardization and future clinical trials.
Identifiants
pubmed: 38959353
doi: 10.1097/PCC.0000000000003480
pii: 00130478-202407000-00009
doi:
Substances chimiques
Anticoagulants
0
Types de publication
Journal Article
Consensus Development Conference
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
643-675Informations de copyright
Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.
Déclaration de conflit d'intérêts
Drs. Alexander’s and Muszynski’s institutions received funding from the National Institutes of Health (NIH). Drs. Alexander, Bembea, Himebauch, Barbaro, and Muszynski received support for article research from the NIH. Drs. Alexander’s and Bembea’s institutions received funding from the Extracorporeal Life Support Organization (ELSO). Dr. Alexander’s institution received funding from Novartis (Prospective Trial to Assess the Angiotensin Receptor Blocker Neprilysin Inhibitor LCZ696 Versus Angiotensin-Converting Enzyme Inhibitor for the Medical Treatment of Pediatric HF [PANORAMA-HF]). Dr. Alexander disclosed that she is Treasurer of the Board of Directors of ELSO, past Co-Chair of Pediatric Extracorporeal Membrane Oxygenation (Pedi-ECMO). Dr. Bembea’s institution received funding from the National Institute of Neurologic Disorders and Stroke and a Grifols Investigator Sponsored Research Grant. Dr. Cheifetz received funding from UptoDate. Dr. Dalton received funding from Innovative Extracorporeal Membrane Oxygenation (ECMO) Concepts, Medtronic, Entegrion, and Hemocue. Drs. Dalton, Ozment, Barbaro, Almond, Brandão, Baumann Kreuziger, Paden, and Ryerson disclosed the off-label product use of pediatric ECMO-related medications for anticoagulation. Dr. Himebauch’s institution received funding from the National Heart, Lung, and Blood Institute (NHLBI) (K23HL153759). Drs. Karam’s and Nellis’s institutions received funding from the NHBLI (R34HL159119). Dr. Ozment received funding from Kaufman & Canoles, Social Cascade, and Wiseman Ashworth Law Group. Dr. Steiner’s institution received funding from the Department of Defense (DoD); she received funding from Medtronic and Octapharma; she disclosed that she is a Pumps for Kids, Infantsand Neonates (PumpKIN) trial Data Safety and Monitoring Board member. Dr. Alexander’s and Thiagarajan’s institution received funding from the DoD Clinical Trial Award for Trial of Indication-Based Transfusion of RBCs in ECMO trial (W81XWH2210301). Dr. Thiagarajan received funding from Society of Critical Care Medicine and ELSO. Dr. Zantek disclosed that she is a Board Member and Vice President of the North American Specialized Coagulation Laboratory Association and Board Member of the American Society for Apheresis, the External Quality Assurance in Thrombosis and Hemostasis, and Blood Network subgroup of Pediatric Acute Lung Injury and Sepsis Investigators groups; she disclosed that her spouse is an employee of Boston Scientific and owns stock in Endo International PLC. Dr. Barbaro’s institution received funding from the NHLBI (R01 HL153519 and K12 HL138039); he disclosed that he is ELSO Board of Directors and Pedi-ECMO Co-Chair. Dr. Emani received funding from Chiesi Pharma. Dr. Hyslop disclosed he is Co-Chair of ELSO Registry Database Development Committee and Coordinator Liaison to ELSO Steering Committee. Dr. Baumann Kreuziger received funding from the Health Resources and Services Administration Vaccine Injury Compensation Program. Dr. Paden disclosed that he is past president and board member of ELSO. Dr. Ryerson received an honorarium from Instrumentation Laboratory for consultation work. Dr. Sloan commenced employment with CSL Behring after the consensus process was complete. Dr. Patregnani received funding from Mallinckrodt; he discloses consultation payments from MNK pharmaceuticals and Pfizer. The Executive Committee (Drs. Alexander, Muszynski, Bembea, Cheifetz, Steiner, and Barbaro) served as arbitrators for conflict-of-interest management. The remaining authors have disclosed that they do not have any potential conflicts of interest.
Références
Barbaro RP, Paden ML, Guner YS, et al.; ELSO member centers: Pediatric extracorporeal life support organization registry international report 2016. ASAIO J 2017; 63:456–463
Extracorporeal Life Support Organization (ELSO): International Summary—ECLS Registry Report. 2023. Available at: https://www.elso.org/registry/internationalsummaryandreports/internationalsummary.aspx. Accessed January 10, 2024
O’Halloran CP, Thiagarajan RR, Yarlagadda VV, et al.: Outcomes of infants supported with extracorporeal membrane oxygenation using centrifugal versus roller pumps: An analysis from the Extracorporeal Life Support Organization Registry. Pediatr Crit Care Med 2019; 20:1177–1184
Dalton HJ, Reeder R, Garcia-Filion P, et al.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network: Factors associated with bleeding and thrombosis in children receiving extracorporeal membrane oxygenation. Am J Respir Crit Care Med 2017; 196:762–771
Ozment CP, Scott BL, Bembea MM, et al.: Anticoagulation and transfusion management during neonatal and pediatric extracorporeal membrane oxygenation: A survey of medical directors in the United States. Pediatr Crit Care Med 2021; 22:530–541
Conrad SA, Broman LM, Taccone FS, et al.: The extracorporeal life support organization Maastricht treaty for nomenclature in extracorporeal life support. A position paper of the extracorporeal life support organization. Am J Respir Crit Care Med 2018; 198:447–451
Nellis ME, Tucci M, Lacroix J, et al.; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network; and the Pediatric Critical Care Blood Research Network (BloodNet): Bleeding Assessment Scale in Critically Ill Children (BASIC): Physician-driven diagnostic criteria for bleeding severity. Crit Care Med 2019; 47:1766–1772
Levy JH, Faraoni D, Almond CS, et al.: Consensus statement: Hemostasis trial outcomes in cardiac surgery and mechanical support. Ann Thorac Surg 2022; 113:1026–1035
Hardin AP, Hackell JM; COMMITTEE ON PRACTICE AND AMBULATORY MEDICINE: Age limit of pediatrics. Pediatrics 2017; 140:e20172151
Watanabe A, Yasuhara J, Karube T, et al.: Extracorporeal membrane oxygenation in children with COVID-19: A systematic review and meta-analysis. Pediatr Crit Care Med 2023; 24:406–416
Bembea MM, Loftis LL, Thiagarajan RR, et al.; Overcoming COVID-19 Investigators: Extracorporeal membrane oxygenation characteristics and outcomes in children and adolescents with COVID-19 or multisystem inflammatory syndrome admitted to U.S. ICUs. Pediatr Crit Care Med 2023; 24:356–371
Guyatt GH, Oxman AD, Kunz R, et al.: GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol 2011; 64:395–400
Fitch K, Bernstein SJ, Aguilar MD, et al.: The RAND/UCLA Appropriateness Method User’s Manual. Santa Monica, CA, RAND, 2001
Diamond IR, Grant RC, Feldman BM, et al.: Defining consensus: A systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol 2014; 67:401–409
Neumann I, Brignardello-Petersen R, Wiercioch W, et al.: The GRADE evidence-to-decision framework: A report of its testing and application in 15 international guideline panels. Implement Sci 2016; 11:93
Rudan I, Yoshida S, Wazny K, et al.: Setting health research priorities using the CHNRI method: V. Quantitative properties of human collective knowledge. J Glob Health 2016; 6:010502
Muszynski JA, Bembea MM, Gehred A, et al.; Pediatric Extracorporeal Membrane Oxygenation (ECMO) Anticoagulation CollaborativE (PEACE), in collaboration with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric ECMO subgroup of PALISI and the Extracorporeal Life Support Organization (PediECMO): Priorities for clinical research in pediatric extracorporeal membrane oxygenation anticoagulation from the Pediatric Extracorporeal Membrane Oxygenation Anticoagulation Collaborative Consensus Conference. Priorities for clinical research in pediatric anticoagulation from the Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference. Pediatr Crit Care Med 2024; 25 (Suppl 1):e78–e89
Himebauch AS, Priest JR, Annich GM, et al.; Pediatric Extracorporeal Membrane Oxygenation (ECMO) Anticoagulation CollaborativE (PEACE), in collaboration with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric ECMO subgroup of PALISI and the Extracorporeal Life Support Organization (PediECMO): The influence of extracorporeal membrane oxygenation circuit and components on anticoagulation management: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference. Pediatr Crit Care Med 2024; 25 (Suppl 1):e1–e6
Cashen K, Saini A, Brandão L, et al.; Pediatric Extracorporeal Membrane Oxygenation (ECMO) Anticoagulation CollaborativE (PEACE), in collaboration with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric ECMO subgroup of PALISI and the Extracorporeal Life Support Organization (PediECMO): Anticoagulant medications: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference. Pediatr Crit Care Med 2024; 25 (Suppl 1):e7–e13
Ozment C, Alexander PMA, Chandler W, et al.; Pediatric Extracorporeal Membrane Oxygenation (ECMO) Anticoagulation CollaborativE (PEACE), in collaboration with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric ECMO subgroup of PALISI and the Extracorporeal Life Support Organization (PediECMO): Anticoagulation monitoring and targets: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference. Pediatr Crit Care Med 2024; 25 (Suppl 1):e14–e24
Nellis ME, Moynihan KM, Sloan SR, et al.; Pediatric Extracorporeal Membrane Oxygenation (ECMO) Anticoagulation CollaborativE (PEACE), in collaboration with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric ECMO subgroup of PALISI and the Extracorporeal Life Support Organization (PediECMO): Prophylactic transfusions strategies in children supported by extracorporeal membrane oxygenation: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference. Pediatr Crit Care Med 2024; 25 (Suppl 1):e25–e34
Zantek ND, Steiner ME, Teruya J, et al.; Pediatric Extracorporeal Membrane Oxygenation (ECMO) Anticoagulation CollaborativE (PEACE), in collaboration with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric ECMO subgroup of PALISI and the Extracorporeal Life Support Organization (PediECMO): Recommendations on monitoring and replacement of antithrombin, fibrinogen and von Willebrand factor in pediatric patients on extracorporeal membrane oxygenation: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference. Pediatr Crit Care Med 2024; 25 (Suppl 1):e35–e43
Moynihan KM, Ryerson L, Le J, et al.; Pediatric Extracorporeal Membrane Oxygenation (ECMO) Anticoagulation CollaborativE (PEACE), in collaboration with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric ECMO subgroup of PALISI and the Extracorporeal Life Support Organization (PediECMO): Antifibrinolytic and adjunct hemostatic agents: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference. Pediatr Crit Care Med 2024; 25 (Suppl 1):e44–e52
Willems A, Anders MM, Garcia A, et al.; Pediatric Extracorporeal Membrane Oxygenation (ECMO) Anticoagulation CollaborativE (PEACE), in collaboration with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric ECMO subgroup of PALISI and the Extracorporeal Life Support Organization (PediECMO): Management of extracorporeal membrane oxygenation anticoagulation in the peri-operative period: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference. Pediatr Crit Care Med 2024; 25 (Suppl 1):e53–e65
Rintoul NE, McMichael ABV, Bembea MM, et al.; Pediatric Extracorporeal Membrane Oxygenation (ECMO) Anticoagulation CollaborativE (PEACE), in collaboration with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric ECMO subgroup of PALISI and the Extracorporeal Life Support Organization (PediECMO): Management of bleeding and thrombotic complications during pediatric extracorporeal membrane oxygenation: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference. Pediatr Crit Care Med 2024; 25 (Suppl 1):e66–e77
Werho DK, Pasquali SK, Yu S, et al.; Extracorporeal Life Support Organization Member Centers: Hemorrhagic complications in pediatric cardiac patients on extracorporeal membrane oxygenation: An analysis of the Extracorporeal Life Support Organization Registry. Pediatr Crit Care Med 2015; 16:276–288
Thomas J, Kostousov V, Teruya J: Bleeding and thrombotic complications in the use of extracorporeal membrane oxygenation. Semin Thromb Hemost 2018; 44:20–29
O’Halloran CP, Andren KG, Mecklosky J, et al.: Mortality and factors associated with hemorrhage during pediatric extracorporeal membrane oxygenation. Pediatr Crit Care Med 2020; 21:75–81
Penk JS, Reddy S, Polito A, et al.: Bleeding and thrombosis with pediatric extracorporeal life support: A roadmap for management, research, and the future from the Pediatric Cardiac Intensive Care Society: Part 2. Pediatr Crit Care Med 2019; 20:1034–1039
Penk JS, Reddy S, Polito A, et al.: Bleeding and thrombosis with pediatric extracorporeal life support: A roadmap for management, research, and the future from the Pediatric Cardiac Intensive Care Society: Part 1. Pediatr Crit Care Med 2019; 20:1027–1033
Nichols WL, Hultin MB, James AH, et al.: The Diagnosis, Evaluation and Management of Von Willebrand Disease. U.S. Department of Health and Human Services NIoH, National Heart, Lung and Blood Institute, NIH Publication No. 08-5832, 2007. Available at: https://www.nhlbi.nih.gov/health-topics/diagnosis-evaluation-and-management-of-von-willebrand-disease. Accessed January 10, 2024
Malloy PC, Grassi CJ, Kundu S, et al.; Standards of Practice Committee with Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Endorsement: Consensus guidelines for periprocedural management of coagulation status and hemostasis risk in percutaneous image-guided interventions. J Vasc Interv Radiol 2009; 20:S240–S249
Patel IJ, Rahim S, Davidson JC, et al.: Society of Interventional Radiology consensus guidelines for the periprocedural management of thrombotic and bleeding risk in patients undergoing percutaneous image-guided interventions-Part II: Recommendations: Endorsed by the Canadian Association for Interventional Radiology and the Cardiovascular and Interventional Radiological Society of Europe. J Vasc Interv Radiol 2019; 30:1168–1184.e1
Douketis JD, Spyropoulos AC, Duncan J, et al.: Perioperative management of patients with atrial fibrillation receiving a direct oral anticoagulant. JAMA Intern Med. 2019; 179:1469–1478
Bembea MM, Valentine SL, Bateman ST, et al.; Pediatric Critical Care Transfusion and Anemia Expertise Initiative (TAXI): The pediatric critical care transfusion and anemia expertise initiative consensus conference methodology. Pediatr Crit Care Med 2018; 19(9S Suppl 1):S93–S97
Nellis ME, Karam O, Valentine SL, et al.; Pediatric Critical Care Transfusion and Anemia EXpertise Initiative—Control/Avoidance of Bleeding (TAXI-CAB), in collaboration with the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network: Executive summary of recommendations and expert consensus for plasma and platelet transfusion practice in critically ill children: From the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB). Pediatr Crit Care Med 2022; 23:34–51
Muszynski JA, Reeder RW, Hall MW, et al.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN): RBC transfusion practice in pediatric extracorporeal membrane oxygenation support. Crit Care Med 2018; 46:e552–e559
Datta S, Chang S, Jackson NJ, et al.: Impact of age of packed RBC transfusion on oxygenation in patients receiving extracorporeal membrane oxygenation. Pediatr Crit Care Med 2019; 20:841–846
Keene SD, Patel RM, Stansfield BK, et al.: Blood product transfusion and mortality in neonatal extracorporeal membrane oxygenation. Transfusion 2020; 60:262–268
O’Halloran CP, Alexander PMA, Andren KG, et al.: RBC exposure in pediatric extracorporeal membrane oxygenation: Epidemiology and factors associated with large blood transfusion volume. Pediatr Crit Care Med 2018; 19:767–774
Qin CX, Yesantharao LV, Merkel KR, et al.: Blood utilization and clinical outcomes in extracorporeal membrane oxygenation patients. Anesth Analg 2020; 131:901–908
Surti J, Jain I, Mishra A, et al.: Venoarterial extra corporeal membrane oxygenation and blood component usage in pediatric patients undergoing cardiac surgery: Single centre experience. Ann Card Anaesth 2021; 24:203–208
Cooper DJ, McQuilten ZK, Nichol A, et al.; TRANSFUSE Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group: Age of red cells for transfusion and outcomes in critically ill adults. N Engl J Med 2017; 377:1858–1867
Steiner ME, Ness PM, Assmann SF, et al.: Effects of red-cell storage duration on patients undergoing cardiac surgery. N Engl J Med 2015; 372:1419–1429
Heddle NM, Cook RJ, Arnold DM, et al.: Effect of short-term vs. long-term blood storage on mortality after transfusion. N Engl J Med 2016; 375:1937–1945
Lacroix J, Hebert PC, Fergusson DA, et al.; ABLE Investigators: Age of transfused blood in critically ill adults. N Engl J Med 2015; 372:1410–1418
Fergusson DA, Hebert P, Hogan DL, et al.: Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth-weight infants: The ARIPI randomized trial. JAMA 2012; 308:1443–1451
Spinella PC, Tucci M, Fergusson DA, et al.; ABC-PICU Investigators, the Canadian Critical Care Trials Group, the Pediatric Acute Lung Injury and Sepsis Investigators Network, the BloodNet Pediatric Critical Care Blood Research Network, and the Groupe Francophone de Réanimation et Urgences P: Effect of fresh vs standard-issue red blood cell transfusions on multiple organ dysfunction syndrome in critically ill pediatric patients: A randomized clinical trial. JAMA 2019; 322:2179–2190
McMichael ABV, Ryerson LM, Ratano D, et al.: 2021 ELSO adult and pediatric anticoagulation guidelines. ASAIO J 2022; 68:303–310
Cholette JM, Muszynski JA, Ibla JC, et al.; Pediatric Critical Care Transfusion and Anemia EXpertise Initiative–Control/Avoidance of Bleeding (TAXI-CAB), in collaboration with the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network: Plasma and platelet transfusions strategies in neonates and children undergoing cardiac surgery with cardiopulmonary bypass or neonates and children supported by extracorporeal membrane oxygenation: From the transfusion and anemia expertise initiative-control/avoidance of bleeding. Pediatr Crit Care Med 2022; 23(13 Suppl 1 1S):e25–e37
Alexander PMA, Habet V, Barbaro RP: Realizing potential: Pediatric extracorporeal membrane oxygenation needs common adverse event definitions to improve outcomes. Pediatr Crit Care Med 2023; 24:528–530