The Use of Tranexamic Acid to Reduce the Need for Nasal Packing in Epistaxis (NoPAC): Randomized Controlled Trial - 21/05/21
, Andrew Appelboam, MBBS a, Kara N. Stevens, PhD b, Jane Vickery, PhD c, Paul Ewings, PhD d, e, Wendy Ingram, PhD c, Alison N. Jeffery, PhD c, Richard Body, PhD f, Malcolm Hilton, BM BCh a, Jason Coppell, MBBS a, Brian Wainman c, Andy Barton, PhD dAbstract |
Study objective |
Epistaxis is a common emergency department (ED) presentation and, if simple first aid measures fail, can lead to a need for anterior nasal packing. Tranexamic acid is an agent that contributes to blood clot stability. The aim of this study is to investigate the effectiveness of topical intranasal tranexamic acid in adult patients presenting to the ED with persistent epistaxis, and whether it reduces the need for anterior nasal packing.
Methods |
From May 5, 2017, to March 31, 2019, a double-blind, placebo-controlled, multicenter, 1:1, randomized controlled trial was conducted across 26 EDs in the United Kingdom. Participants with spontaneous epistaxis, persisting after simple first aid and the application of a topical vasoconstrictor, were randomly allocated to receive topical tranexamic acid or placebo. The primary outcome was the need for anterior nasal packing of any kind during the index ED attendance. Secondary outcome measures included hospital admission, need for blood transfusion, recurrent epistaxis, and any thrombotic events requiring any hospital reattendance within 1 week.
Results |
The study sample consisted of 496 participants with spontaneous epistaxis, persisting after simple first aid and application of a topical vasoconstrictor. In total, 211 participants (42.5%) received anterior nasal packing during the index ED attendance, including 111 of 254 (43.7%) in the tranexamic acid group versus 100 of 242 (41.3%) in the placebo group. The difference was not statistically significant (odds ratio 1.107; 95% confidence interval 0.769 to 1.594; P=.59). Furthermore, there were no statistically significant differences between tranexamic acid and placebo for any of the secondary outcome measures.
Conclusion |
In patients presenting to an ED with atraumatic epistaxis that is uncontrolled with simple first aid measures, topical tranexamic acid applied in the bleeding nostril on a cotton wool dental roll is no more effective than placebo at controlling bleeding and reducing the need for anterior nasal packing.
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| Please see page 632 for the Editor’s Capsule Summary of this article. |
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| Supervising editors: Michael Gottlieb, MD; Steven M. Green, MD. Specific detailed information about possible conflict of interest for individual editors is available at editors. |
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| Author contributions: AR, AA, JV, RB, MH, JC, and AB were responsible for the conception and design of this research. WI and ANJ contributed to protocol development. WI, ANJ, and BW undertook analysis and interpretation of data. KNS and PE were responsible for statistical data analysis. All authors contributed to the interpretation of the results, drafting and reviewing the article, and approval of the final version of the article. AR takes responsibility for the paper as a whole. |
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| All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
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| Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. This study was funded by the National Institute for Health Research (NIHR) Research for Patient Benefit program (project reference PB PG 0215-36142). |
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| Trial registration number: ISRCTN34153772 |
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| The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. |
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Vol 77 - N° 6
P. 631-640 - juin 2021 Retour au numéro
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