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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Tranexamic Acid in Patients Undergoing Noncardiac Surgery
New England Journal of Medicine, Volume 386, No. 21, Year 2022
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Description
Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.67 to 0.87; absolute difference, -2.6 percentage points; 95% CI, -3.8 to -1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 percentage points; 95% CI, -1.1 to 1.7; one-sided P=0.04 for noninferiority). CONCLUSIONS Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established. Copyright © 2022 Massachusetts Medical Society.
Authors & Co-Authors
Devereaux, Philip James
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Marcucci, Maura
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Painter, Thomas W.
Australia, Adelaide
The University of Adelaide
Australia, Adelaide
Royal Adelaide Hospital
Conen, David
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Lomivorotov, Vladimir V.
Russian Federation, Novosibirsk
E.n. Meshalkin National Medical Research Center
Russian Federation, Novosibirsk
Novosibirsk State University
Sessler, Daniel I.
United States, Cleveland
Cleveland Clinic Foundation
Chan, Matthew Tak Vai
Hong Kong, Hong Kong
Chinese University of Hong Kong
Borges, Flávia Kessler
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Martínez Zapata, Ma José
Spain, Barcelona
Institut de Recerca Sant Pau ir Sant Pau
Wang, Chew Yin
Malaysia, Kuala Lumpur
Universiti Malaya
Xavier, Denis
India, Bengaluru
St. John's Medical College
Ofori, Sandra N.
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Wang, Michael K.
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Efremov, Sergey Mihailovich
Russian Federation, Saint Petersburg
Saint-petersburg State University Hospital
Landoni, Giovanni
Italy, Milan
Università Vita-salute San Raffaele
Kleinlugtenbelt, Ydo Vincent
Netherlands, Deventer
Deventer Hospitals
Szczeklik, Wojciech
Poland, Krakow
Jagiellonian University Medical College
Schmartz, Denis
Belgium, Brussels
Université Libre de Bruxelles
Garg, Amit X.
Canada, Hamilton
Mcmaster University
Canada, London
Western University
Short, Timothy G.
New Zealand, Auckland
Auckland City Hospital
Wittmann, Maria
Germany, Bonn
Universitätsklinikum Bonn
Meyhoff, Christian Sylvest
Denmark, Copenhagen
Bispebjerg Hospital
Denmark, Copenhagen
Københavns Universitet
Amir, Mohammed A.
Pakistan, Islamabad
Shifa International Hospital
Torres, David P.
Chile, Santiago
Clinica Santa Maria
Patel, Ameen
Canada, Hamilton
Mcmaster University
Duceppe, Emmanuelle
Canada, Montreal
Centre Hospitalier de L'universite de Montreal
Ruetzler, Kurt
United States, Cleveland
Cleveland Clinic Foundation
Parlow, Joel L.
Canada, Kingston
Queen’s University
Tandon, Vikas
Canada, Hamilton
Mcmaster University
Fleischmann, Edith
Austria, Vienna
Medizinische Universität Wien
Polanczyk, Carisi Anne
Brazil, Porto Alegre
Universidade Federal do Rio Grande do Sul
Lamy, Andre L.
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Astrakov, Sergey V.
Russian Federation, Novosibirsk
Novosibirsk State University
Rao, Mangala B.
India, Bengaluru
St. John's Medical College
Wu, William Ka Kei
Hong Kong, Hong Kong
Chinese University of Hong Kong
Bhatt, Keyur Sureshchandra
Unknown Affiliation
de Nadal Clanchet, Miriam
Spain, Barcelona
Hospital Universitari Vall D'hebron
Likhvantsev, V. V.
Russian Federation, Moscow
Sechenov First Moscow State Medical University
Paniagua, Pilar
Spain, Barcelona
Hospital de la Santa Creu I Sant Pau
Aguado, H. J.
Spain, Valladolid
Hospital Clínico Universitario de Valladolid
Whitlock, Richard Paul
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
McGillion, Michael H.
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Vincent, Jessica
Canada, Hamilton
Population Health Research Institute, Ontario
Eikelboom, John W.
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Copland, Ingrid
Canada, Hamilton
Population Health Research Institute, Ontario
Balasubramanian, Kumar
Canada, Hamilton
Population Health Research Institute, Ontario
Turan, Alparslan M.
United States, Cleveland
Cleveland Clinic Foundation
Bangdiwala, Shrikant I.
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Stillo, David
Canada, Hamilton
Population Health Research Institute, Ontario
Gross, Peter L.
Canada, Hamilton
Mcmaster University
Alfonsi, Pascal
France, Paris
Université Paris Cité
Roshanov, Pavel S.
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, London
Western University
Belley-Côté, Émilie Prudence
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Spence, Jessica D.
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Richards, Toby A.
Australia, Clayton
Monash University
VanHelder, Tomas
Canada, Hamilton
Mcmaster University
McIntyre, William Finlay
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Gordon, Guyatt H.
Canada, Hamilton
Mcmaster University
Yusuf, Salim N.
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Leslie, Kate E.
Australia, Melbourne
University of Melbourne
Statistics
Citations: 103
Authors: 60
Affiliations: 36
Identifiers
Doi:
10.1056/NEJMoa2201171
ISSN:
00284793
Research Areas
Environmental
Health System And Policy
Noncommunicable Diseases
Violence And Injury
Study Design
Randomised Control Trial
Cohort Study