Safety of Topical Tranexamic Acid in Total Joint Arthroplasty in High Risk Patients

Summary

To evaluate whether there is a difference in symptomatic thromboembolism events in the subset of patients with a history of, or risk factors for thromboembolic disease for topically applied tranexamic acid in total joint arthroplasty.

Timeline

Start

2016-02

Primary completion

2019-01

Completion

2019-01

Outcome

Outcome not reported

Stopped: “Study did not receive IRB approval, so did not start”

Publications

• Background Jansen AJ, Andreica S, Claeys M, D'Haese J, Camu F, Jochmans K. Use of tranexamic acid for an effective blood conservation strategy after total knee arthroplasty. Br J Anaesth. 1999 Oct;83(4):596-601. doi: 10.1093/bja/83.4.596.
• Background McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000.
• Background Zhang H, Chen J, Chen F, Que W. The effect of tranexamic acid on blood loss and use of blood products in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2012 Sep;20(9):1742-52. doi: 10.1007/s00167-011-1754-z. Epub 2011 Nov 8.
• Background Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908.
• Background Huang Z, Ma J, Shen B, Pei F. Combination of intravenous and topical application of tranexamic acid in primary total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Dec;29(12):2342-6. doi: 10.1016/j.arth.2014.05.026. Epub 2014 Jun 5.
• Background Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.
• Background Whiting DR, Gillette BP, Duncan C, Smith H, Pagnano MW, Sierra RJ. Preliminary results suggest tranexamic acid is safe and effective in arthroplasty patients with severe comorbidities. Clin Orthop Relat Res. 2014 Jan;472(1):66-72. doi: 10.1007/s11999-013-3134-0.
• Background Duncan CM, Gillette BP, Jacob AK, Sierra RJ, Sanchez-Sotelo J, Smith HM. Venous thromboembolism and mortality associated with tranexamic acid use during total hip and knee arthroplasty. J Arthroplasty. 2015 Feb;30(2):272-6. doi: 10.1016/j.arth.2014.08.022. Epub 2014 Sep 6.

Drugs

Indications