Tranexamic Acid in Patients Undergoing Noncardiac Surgery

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dc.coverageDOI: 10.1056/NEJMoa2201171
dc.creatorDevereaux, P. J.
dc.creatorMarcucci, Maura
dc.creatorPainter, Thomas W.
dc.creatorConen, David
dc.creatorLomivorotov, Vladimir
dc.creatorSessler, Daniel I.
dc.creatorChan, Matthew T.V.
dc.creatorBorges, Flavia K.
dc.creatorMartínez-Zapata, María J.
dc.creatorWang, Chew Yin
dc.creatorXavier, Denis
dc.creatorOfori, Sandra N.
dc.creatorWang, Michael K.
dc.creatorEfremov, Sergey
dc.creatorLandoni, Giovanni
dc.creatorKleinlugtenbelt, Ydo V.
dc.creatorSzczeklik, Wojciech
dc.creatorSchmartz, Denis
dc.creatorGarg, Amit X.
dc.creatorShort, Timothy G.
dc.creatorWittmann, Maria
dc.creatorMeyhoff, Christian S.
dc.creatorAmir, Mohammed
dc.creatorTorres, David
dc.creatorPatel, Ameen
dc.creatorDuceppe, Emmanuelle
dc.creatorRuetzler, Kurt
dc.creatorParlow, Joel L.
dc.creatorTandon, Vikas
dc.creatorFleischmann, Edith
dc.creatorPolanczyk, Carisi A.
dc.creatorLamy, Andre
dc.creatorAstrakov, Sergey V.
dc.creatorRao, Mangala
dc.creatorWu, William K.K.
dc.creatorBhatt, Keyur
dc.creatorde Nadal, Miriam
dc.creatorLikhvantsev, Valery V.
dc.creatorPaniagua, Pilar
dc.creatorAguado, Hector J.
dc.creatorWhitlock, Richard P.
dc.creatorMcGillion, Michael H.
dc.creatorPrystajecky, Michael
dc.creatorVincent, Jessica
dc.creatorEikelboom, John
dc.creatorCopland, Ingrid
dc.creatorBalasubramanian, Kumar
dc.creatorTuran, Alparslan
dc.creatorBangdiwala, Shrikant I.
dc.creatorStillo, David
dc.creatorGross, Peter L.
dc.creatorCafaro, Teresa
dc.creatorAlfonsi, Pascal
dc.creatorRoshanov, Pavel S.
dc.creatorBelley-Côté, Emilie P.
dc.creatorSpence, Jessica
dc.creatorRichards, Toby
dc.creatorVanHelder, Tomas
dc.creatorMcIntyre, William
dc.creatorGuyatt, Gordon
dc.creatorYusuf, Salim
dc.creatorLeslie, Kate
dc.date2022
dc.date.accessioned2025-11-18T19:48:38Z
dc.date.available2025-11-18T19:48:38Z
dc.description<p>BACKGROUND: Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding.</p><p>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.</p><p>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&lt;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).</p><p>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. (Funded by the Canadian Institutes of Health Research and others; POISE-3 ClinicalTrials.gov number, NCT03505723.).</p>eng
dc.identifierhttps://investigadores.uandes.cl/en/publications/2bb78cd6-9b62-4b6f-9644-2495325822c5
dc.identifier.urihttps://repositorio.uandes.cl/handle/uandes/55663
dc.languageeng
dc.rightsinfo:eu-repo/semantics/openAccess
dc.sourcevol.386 (2022) date: 2022-05-26 nr.21 p.1996-1997
dc.subjectAntifibrinolytic Agents/adverse effects
dc.subjectCanada
dc.subjectHemorrhage/etiology
dc.subjectHumans
dc.subjectSurgical Procedures, Operative
dc.subjectThrombosis/chemically induced
dc.subjectTranexamic Acid/adverse effects
dc.titleTranexamic Acid in Patients Undergoing Noncardiac Surgeryeng
dc.typeArticleeng
dc.typeArtículospa
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