Randomized clinical trial of topical tranexamic acid after reduction mammoplasty

K Ausen, R Fossmark, O Spigset, H Pleym, K Ausen, R Fossmark, O Spigset, H Pleym

Abstract

Background: The antifibrinolytic drug tranexamic acid is currently being rediscovered for both trauma and major surgery. Intravenous administration reduces the need for blood transfusion and blood loss by about one-third, but routine administration in surgery is not yet advocated owing to concerns regarding thromboembolic events. The aim of this study was to investigate whether topical application of tranexamic acid to a wound surface reduces postoperative bleeding.

Methods: This was a randomized double-blind placebo-controlled trial on 30 consecutive women undergoing bilateral reduction mammoplasty. On one side the wound surfaces were moistened with 25 mg/ml tranexamic acid before closure, and placebo (saline) was used on the other side. Drain fluid production was measured for 24 h after surgery, and pain was measured after 3 and 24 h. Postoperative complications including infection, seroma, rebleeding and suture reactions were recorded.

Results: Topical application of tranexamic acid to the wound surface after reduction mammoplasty reduced drain fluid production by 39 per cent (median 12·5 (range 0-44) versus 20·5 (0-100) ml; P = 0·038). Adverse effects were not observed. There were no significant differences in postoperative pain scores or complications.

Conclusion: Topical application of dilute tranexamic acid reduced bleeding in this model. The study adds to the evidence that this simple procedure may reduce wound bleeding after surgery.

Registration number: NCT01964781 ( http://www.clinicaltrials.gov).

© 2015 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.

Figures

Fig. 1
Fig. 1
CONSORT diagram for the study

References

    1. Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999;57:1005–1032.
    1. Ker K, Prieto-Merino D, Roberts I. Systematic review, meta-analysis and meta-regression of the effect of tranexamic acid on surgical blood loss. Br J Surg. 2013;100:1271–1279.
    1. Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012;344 e3054.
    1. Ngaage DL, Bland JM. Lessons from aprotinin: is the routine use and inconsistent dosing of tranexamic acid prudent? Meta-analysis of randomised and large matched observational studies. Eur J Cardiothorac Surg. 2010;37:1375–1383.
    1. Horrow JC, Van Riper DF, Strong MD, Grunewald KE, Parmet JL. The dose–response relationship of tranexamic acid. Anesthesiology. 1995;82:383–392.
    1. Poeran J, Rasul R, Suzuki S, Danninger T, Mazumdar M, Opperer M, et al. Tranexamic acid use and postoperative outcomes in patients undergoing total hip or knee arthroplasty in the United States: retrospective analysis of effectiveness and safety. BMJ. 2014;349:g4829.
    1. Yee BE, Wissler RN, Zanghi CN, Feng C, Eaton MP. The effective concentration of tranexamic acid for inhibition of fibrinolysis in neonatal plasma in vitro. Anesth Analg. 2013;117:767–772.
    1. Andersson L, Eriksson O, Hedlund PO, Kjellman H, Lindqvist B. Special considerations with regard to the dosage of tranexamic acid in patients with chronic renal diseases. Urol Res. 1978;6:83–88.
    1. Dowd NP, Karski JM, Cheng DC, Carroll JA, Lin Y, James RL, et al. Pharmacokinetics of tranexamic acid during cardiopulmonary bypass. Anesthesiology. 2002;97:390–399.
    1. Murkin JM, Falter F, Granton J, Young B, Burt C, Chu M. High-dose tranexamic acid is associated with nonischemic clinical seizures in cardiac surgical patients. Anesth Analg. 2010;110:350–353.
    1. Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, Fergusson DA, et al. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2011;(3) CD001886.
    1. Koster A, Schirmer U. Re-evaluation of the role of antifibrinolytic therapy with lysine analogs during cardiac surgery in the post aprotinin era. Curr Opin Anaesthesiol. 2011;24:92–97.
    1. Ker K, Roberts I. Tranexamic acid for surgical bleeding. BMJ. 2014;349:g4934.
    1. Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, et al. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010;92:2503–2513.
    1. De Bonis M, Cavaliere F, Alessandrini F, Lapenna E, Santarelli F, Moscato U, et al. Topical use of tranexamic acid in coronary artery bypass operations: a double-blind, prospective, randomized, placebo-controlled study. J Thorac Cardiovasc Surg. 2000;119:575–580.
    1. Ipema HJ, Tanzi MG. Use of topical tranexamic acid or aminocaproic acid to prevent bleeding after major surgical procedures. Ann Pharmacother. 2012;46:97–107.
    1. Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Pérez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014;96:1937–1944.
    1. Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplasty. 2013;28:1080–1083.
    1. Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014;21:987–993.
    1. Alshryda S, Sukeik M, Sarda P, Blenkinsopp J, Haddad FS, Mason JM. A systematic review and meta-analysis of the topical administration of tranexamic acid in total hip and knee replacement. Bone Joint J. 2014;96-b:1005–1015.
    1. Tuttle JR, Ritterman SA, Cassidy DB, Anazonwu WA, Froehlich JA, Rubin LE. Cost benefit analysis of topical tranexamic acid in primary total hip and knee arthroplasty. J Arthroplasty. 2014;29:1512–1515.
    1. Abrishami A, Chung F, Wong J. Topical application of antifibrinolytic drugs for on-pump cardiac surgery: a systematic review and meta-analysis. Can J Anaesth. 2009;56:202–212.
    1. Zahed R, Moharamzadeh P, Alizadeharasi S, Ghasemi A, Saeedi M. A new and rapid method for epistaxis treatment using injectable form of tranexamic acid topically: a randomized controlled trial. Am J Emerg Med. 2013;31:1389–1392.
    1. Sarris I, Arafa A, Konaris L, Kadir RA. Topical use of tranexamic acid to control perioperative local bleeding in gynaecology patients with clotting disorders: two cases. Haemophilia. 2007;13:115–116.
    1. Tang YM, Chapman TW, Brooks P. Use of tranexamic acid to reduce bleeding in burns surgery. J Plast Reconstr Aesthet Surg. 2012;65:684–686.
    1. Hinder D, Tschopp K. 2015;94:86–90. [Topical application of tranexamic acid to prevent post-tonsillectomy haemorrhage.] Laryngorhinootologie.
    1. Athanasiadis T, Beule AG, Wormald PJ. Effects of topical antifibrinolytics in endoscopic sinus surgery: a pilot randomized controlled trial. Am J Rhinol. 2007;21:737–742.
    1. Patatanian E, Fugate SE. Hemostatic mouthwashes in anticoagulated patients undergoing dental extraction. Ann Pharmacother. 2006;40:2205–2210.
    1. Barnard J, Millner R. A review of topical hemostatic agents for use in cardiac surgery. Ann Thorac Surg. 2009;88:1377–383.
    1. Sterling JP, Heimbach DM. Hemostasis in burn surgery – a review. Burns. 2011;37:559–565.
    1. Walsh K, Nikkhah D, Dheansa B. What is the evidence for tranexamic acid in burns? Burns. 2014;40:1055–1057.
    1. Kjersti A. 2015. 20 ml Fluid on AquaDoodle Canvas. [accessed 1 March ]
    1. 2012. Paired t-test. [accessed 2 January]
    1. Lehmann EL. Comparing two treatments of attributes in a population model. In: Lehmann EL, editor. Nonparametrics: Statistical Methods Based on Ranks. New York: Springer; 1998. pp. 76–81.
    1. Stojkovic CA, Smeulders MJ, der Horst CM Van, Khan SM. Wound drainage after plastic and reconstructive surgery of the breast. Cochrane Database Syst Rev. 2013;(3) CD007258.
    1. Overbosch HC, Hart HC. Local application of epsilon-aminocaproic acid (E.A.C.A.) in the prevention of haemorrhage after tonsillectomy. J Laryngol Otol. 1970;84:905–908.
    1. Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013;(7) CD010562.

Source: PubMed

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