Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial

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  • Additional Information
    • Subject Terms:
    • Abstract:
      Summary Background Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding.
    • Abstract:
      Findings Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82–1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98).
    • Abstract:
      Interpretation We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial.
    • Abstract:
      Funding UK National Institute for Health Research Health Technology Assessment Programme.
    • ISSN:
      0140-6736
    • Accession Number:
      10.1016/S0140-6736(20)30848-5
    • Accession Number:
      S0140673620308485
    • Copyright:
      © 2020 The Author(s). Published by Elsevier Ltd.
  • Citations
    • ABNT:
      ROBERTS, I. et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. The Lancet, [s. l.], v. 395, n. 10241, p. 1927–1936, 2020. DOI 10.1016/S0140-6736(20)30848-5. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edselp&AN=S0140673620308485. Acesso em: 26 nov. 2020.
    • AMA:
      Roberts I, Shakur-Still H, Afolabi A, et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. The Lancet. 2020;395(10241):1927-1936. doi:10.1016/S0140-6736(20)30848-5
    • APA:
      Roberts, I., Shakur-Still, H., Afolabi, A., Akere, A., Arribas, M., Brenner, A., Chaudhri, R., Gilmore, I., Halligan, K., Hussain, I., Jairath, V., Javaid, K., Kayani, A., Lisman, T., Mansukhani, R., Mutti, M., Arif Nadeem, M., Pollok, R., Simmons, J., … Lawton, L. (2020). Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. The Lancet, 395(10241), 1927–1936. https://doi.org/10.1016/S0140-6736(20)30848-5
    • Chicago/Turabian: Author-Date:
      Roberts, Ian, Haleema Shakur-Still, Adefemi Afolabi, Adegboyega Akere, Monica Arribas, Amy Brenner, Rizwana Chaudhri, et al. 2020. “Effects of a High-Dose 24-h Infusion of Tranexamic Acid on Death and Thromboembolic Events in Patients with Acute Gastrointestinal Bleeding (HALT-IT): An International Randomised, Double-Blind, Placebo-Controlled Trial.” The Lancet 395 (10241): 1927–36. doi:10.1016/S0140-6736(20)30848-5.
    • Harvard:
      Roberts, I. et al. (2020) ‘Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial’, The Lancet, 395(10241), pp. 1927–1936. doi: 10.1016/S0140-6736(20)30848-5.
    • Harvard: Australian:
      Roberts, I, Shakur-Still, H, Afolabi, A, Akere, A, Arribas, M, Brenner, A, Chaudhri, R, Gilmore, I, Halligan, K, Hussain, I, Jairath, V, Javaid, K, Kayani, A, Lisman, T, Mansukhani, R, Mutti, M, Arif Nadeem, M, Pollok, R, Simmons, J, Soomro, M, Stanworth, S, Veitch, A, Hawkey, C, Afolabi, A, Cuzick, J, Halligan, K, Henry, D, Metcalfe, C, Roberts, I, Gray, R, Barkun, A, David, S, Devereaux, P, Brady, T, Roberts, I, Shakur-Still, H, Coats, T, Edwards, P, Gilmore, I, Jairath, V, Ker, K, Manno, D, Stanworth, S, Veitch, A, Arribas, M, Austin, E, Bal, K, Balogun, E, Barrow, C, Beaumont, D, Benyahia, M, Brenner, A, Brooks, I, Cargill, M, Carrington, L, Edwards, P, Frimley, L, Geer, A, Gilbert, D, Gilliam, C, Gil Onandia, J, Golfi, N, Hetherington, D, Howe, C, Hughes, C, I’anson, D, Jackson, R, Joshi, M, Kansagra, S, Kawahara, T, Ker, K, Kostrov, S, Manno, D, Mansukhani, R, Miah, H, Ndungu, B, Needham, K, Outtandy, A, Pearson, D, Pepple, T, Prowse, D, Quashi, N, Quinn, A, Ramos, M, Ranopa, L, Reid, M, Roberts, I, Roukas, C, Shakur-Still, H, Squires, C, Tanner, J, Thayne, A, Uddin, R, Chaudhri, R, Mutti, M, Javaid, K, Kayani, A, Fawole, B, Bello, FA, et al. 2020, ‘Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial’, The Lancet, vol. 395, no. 10241, pp. 1927–1936, viewed 26 November 2020, .
    • MLA:
      Roberts, Ian, et al. “Effects of a High-Dose 24-h Infusion of Tranexamic Acid on Death and Thromboembolic Events in Patients with Acute Gastrointestinal Bleeding (HALT-IT): An International Randomised, Double-Blind, Placebo-Controlled Trial.” The Lancet, vol. 395, no. 10241, June 2020, pp. 1927–1936. EBSCOhost, doi:10.1016/S0140-6736(20)30848-5.
    • Chicago/Turabian: Humanities:
      Roberts, Ian, Haleema Shakur-Still, Adefemi Afolabi, Adegboyega Akere, Monica Arribas, Amy Brenner, Rizwana Chaudhri, et al. “Effects of a High-Dose 24-h Infusion of Tranexamic Acid on Death and Thromboembolic Events in Patients with Acute Gastrointestinal Bleeding (HALT-IT): An International Randomised, Double-Blind, Placebo-Controlled Trial.” The Lancet 395, no. 10241 (June 20, 2020): 1927–36. doi:10.1016/S0140-6736(20)30848-5.
    • Vancouver/ICMJE:
      Roberts I, Shakur-Still H, Afolabi A, Akere A, Arribas M, Brenner A, et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. The Lancet [Internet]. 2020 Jun 20 [cited 2020 Nov 26];395(10241):1927–36. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edselp&AN=S0140673620308485