Antifibrinolytic and Adjunct Hemostatic Agents: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference
- PMID: 38959359
- PMCID: PMC11216380
- DOI: 10.1097/PCC.0000000000003491
Antifibrinolytic and Adjunct Hemostatic Agents: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference
Abstract
Objectives: To derive systematic-review informed, modified Delphi consensus regarding antifibrinolytic and adjunct hemostatic agents in neonates and children supported with extracorporeal membrane oxygenation (ECMO) for the Pediatric ECMO Anticoagulation CollaborativE consensus conference.
Data sources: A structured literature search was performed using PubMed, EMBASE, and Cochrane Library (CENTRAL) databases from January 1988 to May 2021.
Study selection: Use of antifibrinolytics (epsilon-aminocaproic acid [EACA] or tranexamic acid), recombinant factor VII activated (rFVIIa), or topical hemostatic agents (THAs).
Data extraction: Two authors reviewed all citations independently, with a third independent reviewer resolving conflicts. Eleven references were used for data extraction and informed recommendations. Evidence tables were constructed using a standardized data extraction form.
Measurements and main results: Risk of bias was assessed using the Quality in Prognosis Studies tool. The evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation system. Forty-eight experts met over 2 years to develop evidence-based recommendations and, when evidence was lacking, expert-based consensus statements for the management of bleeding and thrombotic complications in pediatric ECMO patients. A web-based modified Delphi process was used to build consensus via the Research And Development/University of California Appropriateness Method. Consensus was defined as greater than 80% agreement. One weak recommendation and three consensus statements are presented.
Conclusions: Evidence supporting recommendations for administration of antifibrinolytics (EACA or tranexamic acid), rFVIIa, and THAs were sparse and inconclusive. Much work remains to determine effective and safe usage strategies.
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.
Conflict of interest statement
The Executive Committee (Drs. Alexander, Muszynski, Bembea, Cheifetz, Steiner, and Barbaro) served as arbitrators for conflict of interest management. Dr. Alexander’s institution received funding from Novartis (Prospective Trial to Assess the Angiotensin Receptor Blocker NeprilysinInhibitor LCZ696 Versus Angiotensin-Converting Enzyme Inhibitor for the Medical Treatmentof Pediatric HF [PANORAMA-HF]). Dr. Ryerson received an honorarium from the Instrumentation Laboratory for consultation work. Dr. Ryerson disclosed the off-label product use of antifibrinolytic agents (epsilon-aminocaproic acid and tranexamic acid) and topical hemostatic agents. Drs. Alexander and Muszynski’s institutions received funding from the National Institutes of Health (NIH) and received support for article research from the NIH. Dr. Alexander’s institution received funding from the Extracorporeal Life Support Organization and Novartis. Dr. Steiner’s institution received funding from the Department of Defense; she received funding from Octapharma and Medtronic; she disclosed she was on the Data Safety and Monitoring Board for the Pumps for Kids, Infants and Neonates (PumpKIN) Trial; she disclosed the off-label product use of rFVIIa, Kcentra, antithrombin, tranexamic acid, and Amicar. The remaining authors have disclosed that they do not have any potential conflicts of interest.
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References
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- 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 - PMC - PubMed
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- 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 - PubMed
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- Extracorporeal Life Support Organization (ELSO): International Summary—ECLS Registry Report 2023 30 July 2023. Available at: https://www.elso.org/registry/internationalsummaryandreports/internation.... Accessed January 10, 2024
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