Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3) : a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
Marcucci, Maura (Population Health Research Institute)
Painter, Thomas W. (Department of Anaesthesia. Royal Adelaide Hospital)
Conen, David (Population Health Research Institute)
Leslie, Kate (Department of Critical Care Medicine. Melbourne Medical School. University of Melbourne)
Lomivorotov, Vladimir V. (Department of Anesthesiology and Intensive Care. Novosibirsk State University)
Sessler, Daniel (Department of Outcomes Research. Anesthesiology Institute. Cleveland Clinic)
Chan, Matthew T.V. (The Chinese University of Hong Kong)
Borges, Flavia K. (Population Health Research Institute)
Martinez-Zapata, Maria José (Institut d'Investigació Biomèdica Sant Pau)
Wang, C.Y. (Department of Anaesthesiology. Faculty of Medicine. University of Malaya)
Xavier, Denis (St. John's Medical College)
Ofori, Sandra N. (Population Health Research Institute)
Landoni, G. (School of Medicine. Vita-Salute San Raffaele University)
Efremov, Sergey (Saint Petersburg State University Hospital)
Kleinlugtenbelt, Y.V. (Department of Orthopedic and Trauma Surgery. Deventer Ziekenhuis)
Szczeklik, W. (Jagiellonian University Medical College. Center for Intensive Care and Perioperative Medicine)
Schmartz, D. (CHU Brugmann. Université libre de Bruxelles)
Garg, A. X. (Department of Medicine. Epidemiology and Biostatistics. Western University)
Short, T.G. (University of Auckland. School of Health Sciences)
Wittmann, M. (Department of Anesthesiology. University Hospital)
Meyhoff, C.S. (Department of Anaesthesia and Intensive Care. Bispebjerg and Frederiksberg Hospital. University of Copenhagen)
Amir, Mohammed (Shifa International Hospital (STMU))
Torres, D. (Universidad de Los Andes)
Patel, A. (Department of Medicine. McMaster University)
Duceppe, E. (Department of Medicine. Universite de Montreal)
Ruetzler, K. (Department of Outcomes Research. Anesthesiology Institute. Cleveland Clinic)
Parlow, Joel (Department of Anesthesiology and Perioperative Medicine. Kingston General Hospital and Queen's University)
Tandon, V. (Department of Medicine. McMaster University)
Wang, M.K. (Population Health Research Institute)
Fleischmann, E. (Department of Anesthesia. General Intensive Care and Pain Management. Medical University of Vienna)
Polanczyk, C.A. (Hospital de Clínicas de Porto Alegre (Brasil))
Jayaram, R. (Nuffield Department of Anaesthetics. Clinical Neurosciences. University of Oxford)
Astrakov, S.V. (Department of Anesthesiology. Novosibirsk State University)
Rao, M. (St. John's Medical College)
VanHelder, T. (Department of Anesthesia. McMaster University)
Wu, W.K.K. (The Chinese University of Hong Kong)
Cheong, C.C. (Department of Anaesthesiology. Faculty of Medicine. University of Malaya)
Ayad, S. (Case Western Reserve University. Anesthesiology Institute. Cleveland Clinic - Fairview Hospital)
Abubakirov, M. (Meshalkin National Medical Research Center)
Kirov, M. (Department of Anesthesiology and Intensive Care Medicine. Northern State Medical University)
Bhatt, Keyur (SIDS Hospital & Research Centre)
de Nadal, M. (Hospital Universitari Vall d'Hebron)
Likhvantsev, V. (M. Vladimirskiy Moscow Regional Clinical and Research Institute)
Paniagua, Pilar (Institut d'Investigació Biomèdica Sant Pau)
Aguado, Héctor J (Trauma & Orthopaedic surgery department. Hospital Clínico Universitario)
McGillion, M. (School of Nursing. McMaster University)
Lamy, A. (Department of Surgery. McMaster University)
Whitlock, R.P. (Department of Surgery. McMaster University)
Roshanov, P. (Department of Medicine. London Health Sciences Centre)
Stillo, D. (Population Health Research Institute)
Copland, I. (Population Health Research Institute)
Vincent, J. (Population Health Research Institute)
Balasubramanian, K. (Population Health Research Institute)
Bangdiwala, S.I. (Population Health Research Institute)
Biccard, Bruce M (Department of Anaesthesia and Perioperative Medicine. Groote Schuur Hospital and University of Cape Town)
Kurz, A. (Department of General Anaesthesiology. Emergency- and Intensive Care Medicine. Medical University Graz)
Srinathan, S. (Department of Surgery. University of Manitoba)
Petit, S. (Population Health Research Institute)
Eikelboom, J. (Population Health Research Institute)
Richards, T. (Faculty of Health and Medical Sciences. University of Western Australia)
Gross, P.L. (Department of Medicine. McMaster University)
Alfonsi, P. (Department of Anesthesiology. GH Paris Saint Joseph)
Guyatt, G. (Department of Medicine. McMaster University)
Belley-Cote, E. (Population Health Research Institute)
Spence, J. (Department of Anesthesia. McMaster University)
McIntyre, W. (Population Health Research Institute)
Yusuf, S. (Population Health Research Institute)
Devereaux, P. J (Population Health Research Institute)

Data:	2022
Resum:	Background: For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i. e. , most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes. Methods: The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients ≥45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on ≥ 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization. Discussion: Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality. Trial registration: ClinicalTrials. gov NCT03505723. Registered on 23 April 2018.
Ajuts:	Instituto de Salud Carlos III CP1120/00023
Nota:	Altres ajuts: Canadian Institutes of Health Research (CIHR, FDN-143302); General Research Fund (14104419), Research Grant Council, Hong Kong SAR, China; National Health and Medical Research Council, Funding Schemes (NHMRC Project Grant 1162362), Australia; McMaster University Department of Medicine Career Research Award and a Physicians' Services Incorporated (PSI) Foundation Mid-Career Clinical Research Award.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Noncardiac surgery ; Tranexamic acid ; Perioperative bleeding ; Perioperative hypotension ; Cardiovascular complications ; Randomized controlled trial
Publicat a:	Trials, Vol. 23 Núm. 1 (december 2022) , p. 101, ISSN 1745-6215

DOI: 10.1186/s13063-021-05992-1
PMID: 35101083

12 p, 1.3 MB

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