Study Comparing Topical Versus Intravenous Tranexamic Acid in Anterior Total Hip Arthroplasty

Summary

Brief Summary Title: Prospective Randomized Trial Comparing Topical Versus Intravenous Tranexamic Acid (TXA) in Anterior (Total hip arthroplasty) Several strategies have been used to reduce transfusion requirements during total hip arthroplasty (THA). Recently, anti-fibrinolytic agent TXA, has been used extensively in THAs to minimize intra-operative blood losses. However, few studies have compared the efficacy of topical versus intravenous use in direct anterior THA. Therefore, the investigators will attempt to evaluate differences in the post-operative outcomes of topical versus intravenous TXA in Direct anterior approach to THA. The investigators propose to conduct a prospective randomized study in which patients who have exhausted non-operative treatment for hip osteoarthritis and are opting for THA will be randomized into 3 groups in a 1:1:1 ratio based on a computer generated algorithm following inclusion and exclusion criteria as described below. Patients will be distributed in to 3 groups as follows: Group A: Intravenous TXA at a dose of 1 gram administered 30 min prior to skin incision and 1 gram 3 hours after the procedure. (Total dose: 2 grams) Group B: Topical TXA at a dose of 1 gram injected in to the peri-articular tissues prior to closure and 1 gram injected into the joint through the drain following wound closure. (Total dose:2 grams) Group C: Combined Intravenous 1 gram given intravenous 30 min prior to skin incision and topical TXA (1 gram) injected into the peri-articular tissues prior to closure. (Total dose: 2 grams). The number of subjects needed to achieve 90% power was calculated based on a one-way fixed effects analysis of variance with 3 levels. Primary endpoint used was drainage measured in milliliters in the post-operative (POD) #1 following surgery. Criterion for significance (alpha) was set at 0.05 and the ANOVA statistics was non-directional (two tailed). Preliminary data indicated that drainage volume averages 250 ml with a standard deviation of 160 ml in our operating room. Difference (maximum to minimum of the three levels) of 150 ml was judged to be the minimally clinically relevant difference in drainage volume (effect size =0.38). A 20% loss to follow up was also assumed. The study will need 38 cases per cell for a total of 114 cases to achieve 90% power of detecting a difference this large. Data metrics will be tabulated into excel spreadsheets. Data analysis will be performed using statistical software. Quantitative data will be analyzed using non-directional analysis of variance (ANOVA) with Tukey's test for multiple comparisons. Non-normality or heteroscedasticity of data will either be corrected by transformation or a non-parametric (Kruskal Wallis) test will be used. Categorical data will be analyzed using chi-square tests (or Fisher's exact test if any cells expected value is 5 or less). A p-value \<0.05 will be considered statistically significant.

Timeline

Start

2017-07-01

Primary completion

2019-06-30

Completion

2019-12-31

Publications

• Results Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
• Results Carling MS, Jeppsson A, Eriksson BI, Brisby H. Transfusions and blood loss in total hip and knee arthroplasty: a prospective observational study. J Orthop Surg Res. 2015 Mar 28;10:48. doi: 10.1186/s13018-015-0188-6.
• Results Kasparek MF, Faschingbauer M, Waldstein W, Boettner CS, Boettner F. Topical Tranexamic Acid is Equivalent to Targeted Preoperative Autologous Blood Donation in Total Hip Arthroplasty. J Arthroplasty. 2017 Apr;32(4):1176-1179. doi: 10.1016/j.arth.2016.10.026. Epub 2016 Oct 31.
• Results Shang J, Wang H, Zheng B, Rui M, Wang Y. Combined intravenous and topical tranexamic acid versus intravenous use alone in primary total knee and hip arthroplasty: A meta-analysis of randomized controlled trials. Int J Surg. 2016 Dec;36(Pt A):324-329. doi: 10.1016/j.ijsu.2016.11.033. Epub 2016 Nov 14.
• Results Moskal JT, Capps SG. Meta-analysis of Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty. Orthopedics. 2016 Sep 1;39(5):e883-92. doi: 10.3928/01477447-20160526-02. Epub 2016 Jun 1.
• Results Anand A, Melvin JS. Tranexamic Acid in Hip and Knee Arthroplasty. J Am Acad Orthop Surg. 2016 Jun;24(6):e59. doi: 10.5435/JAAOS-D-15-00708. No abstract available.
• Results Wei Z, Liu M. The effectiveness and safety of tranexamic acid in total hip or knee arthroplasty: a meta-analysis of 2720 cases. Transfus Med. 2015 Jun;25(3):151-62. doi: 10.1111/tme.12212. Epub 2015 May 29.
• Results Wang C, Xu GJ, Han Z, Ma JX, Ma XL, Jiang X, Wang Y. Topical application of tranexamic acid in primary total hip arthroplasty: a systemic review and meta-analysis. Int J Surg. 2015 Mar;15:134-9. doi: 10.1016/j.ijsu.2014.12.023. Epub 2015 Jan 7.
• Results Wu YG, Zeng Y, Yang TM, Si HB, Cao F, Shen B. The Efficacy and Safety of Combination of Intravenous and Topical Tranexamic Acid in Revision Hip Arthroplasty: A Randomized, Controlled Trial. J Arthroplasty. 2016 Nov;31(11):2548-2553. doi: 10.1016/j.arth.2016.03.059. Epub 2016 Apr 12.
• Results Poeran J, Rasul R, Suzuki S, Danninger T, Mazumdar M, Opperer M, Boettner F, Memtsoudis SG. 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 Aug 12;349:g4829. doi: 10.1136/bmj.g4829.
• Results Madsen RV, Nielsen CS, Kallemose T, Husted H, Troelsen A. Low Risk of Thromboembolic Events After Routine Administration of Tranexamic Acid in Hip and Knee Arthroplasty. J Arthroplasty. 2017 Apr;32(4):1298-1303. doi: 10.1016/j.arth.2016.10.015. Epub 2016 Oct 20.
• Results Hanna SA, Prasad A, Lee J, Achan P. Topical Versus Intravenous Administration of Tranexamic Acid in Primary Total Hip Arthroplasty: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Orthop Rev (Pavia). 2016 Sep 19;8(3):6792. doi: 10.4081/or.2016.6792. eCollection 2016 Sep 19.
• Results Chen Y, Chen Z, Cui S, Li Z, Yuan Z. Topical versus systemic tranexamic acid after total knee and hip arthroplasty: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2016 Oct;95(41):e4656. doi: 10.1097/MD.0000000000004656.
• Results Hallstrom B, Singal B, Cowen ME, Roberts KC, Hughes RE. The Michigan Experience with Safety and Effectiveness of Tranexamic Acid Use in Hip and Knee Arthroplasty. J Bone Joint Surg Am. 2016 Oct 5;98(19):1646-1655. doi: 10.2106/JBJS.15.01010.
• Results Li J, Zhang Z, Chen J. Comparison of efficacy and safety of topical versus intravenous tranexamic acid in total hip arthroplasty: A meta-analysis. Medicine (Baltimore). 2016 Sep;95(36):e4689. doi: 10.1097/MD.0000000000004689.
• Results Babis GC. Controversy in Tranexamic Acid Administration Route Continues: Commentary on an article by Zeng Yi, MD, et al.: "Tranexamic Acid Administration in Primary Total Hip Arthroplasty: A Randomized Controlled Trial of Intravenous Combined with Topical Versus Single-Dose Intravenous Administration". J Bone Joint Surg Am. 2016 Jun 15;98(12):e51. doi: 10.2106/JBJS.16.00128. No abstract available.
• Results Yi Z, Bin S, Jing Y, Zongke Z, Pengde K, Fuxing P. Tranexamic Acid Administration in Primary Total Hip Arthroplasty: A Randomized Controlled Trial of Intravenous Combined with Topical Versus Single-Dose Intravenous Administration. J Bone Joint Surg Am. 2016 Jun 15;98(12):983-91. doi: 10.2106/JBJS.15.00638.
• Results Kang JS, Moon KH, Kim BS, Yang SJ. Topical administration of tranexamic acid in hip arthroplasty. Int Orthop. 2017 Feb;41(2):259-263. doi: 10.1007/s00264-016-3195-2. Epub 2016 Apr 18.
• Results North WT, Mehran N, Davis JJ, Silverton CD, Weir RM, Laker MW. Topical vs Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty: A Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2016 Apr;31(4):928-9. doi: 10.1016/j.arth.2015.12.001. Epub 2015 Dec 17. No abstract available.
• Results North WT, Mehran N, Davis JJ, Silverton CD, Weir RM, Laker MW. Topical vs Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty: A Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2016 May;31(5):1022-6. doi: 10.1016/j.arth.2015.11.003. Epub 2015 Nov 10.
• Results Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology. 1983 Mar;58(3):277-80. doi: 10.1097/00000542-198303000-00016. No abstract available.
• Results Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
• Results Liu X, Zhang X, Chen Y, Wang Q, Jiang Y, Zeng B. Hidden blood loss after total hip arthroplasty. J Arthroplasty. 2011 Oct;26(7):1100-5.e1. doi: 10.1016/j.arth.2010.11.013. Epub 2011 Jan 21.

Drugs

Indications

No indication recorded.