Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF)

Summary

The randomized controlled study which compare the efficacy outcomes (reducing blood loss and drainage output in patients) in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) and received topical tranexamic acid injection in the surgical site to those who received placebo injection.

Timeline

Start

2024-07-01

Primary completion

2026-12-01

Completion

2026-12-01

Publications

• Background Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
• Background Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):936-43. doi: 10.1097/01.brs.0000158953.57966.c0.
• Background Harms JG, Jeszenszky D. Die posteriore, lumbale, interkorporelle Fusion in unilateraler transforaminaler Technik. Oper Orthop Traumatol. 1998 Jun;10(2):90-102. doi: 10.1007/s00064-006-0112-7. No abstract available. German.
• Background Holly LT, Schwender JD, Rouben DP, Foley KT. Minimally invasive transforaminal lumbar interbody fusion: indications, technique, and complications. Neurosurg Focus. 2006 Mar 15;20(3):E6. doi: 10.3171/foc.2006.20.3.7.
• Background Moskowitz A. Transforaminal lumbar interbody fusion. Orthop Clin North Am. 2002 Apr;33(2):359-66. doi: 10.1016/s0030-5898(01)00008-6.
• Background Hong JY, Kim WS, Park J, Kim CH, Jang HD. Comparison of minimally invasive and open TLIF outcomes with more than seven years of follow-up. N Am Spine Soc J. 2022 Jun 11;11:100131. doi: 10.1016/j.xnsj.2022.100131. eCollection 2022 Sep.
• Background Kleinert K, Theusinger OM, Nuernberg J, Werner CM. Alternative procedures for reducing allogeneic blood transfusion in elective orthopedic surgery. HSS J. 2010 Sep;6(2):190-8. doi: 10.1007/s11420-009-9151-6. Epub 2010 Jan 28.
• Background Dodd RY. The risk of transfusion-transmitted infection. N Engl J Med. 1992 Aug 6;327(6):419-21. doi: 10.1056/NEJM199208063270610. No abstract available.
• Background Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussieres JS, McGuinness S, Byrne K, Chan MT, Landoni G, Wallace S; ATACAS Investigators of the ANZCA Clinical Trials Network. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery. N Engl J Med. 2017 Jan 12;376(2):136-148. doi: 10.1056/NEJMoa1606424. Epub 2016 Oct 23.
• Background Danninger T, Memtsoudis SG. Tranexamic acid and orthopedic surgery-the search for the holy grail of blood conservation. Ann Transl Med. 2015 Apr;3(6):77. doi: 10.3978/j.issn.2305-5839.2015.01.25. No abstract available.
• Background Badeaux J, Hawley D. A systematic review of the effectiveness of intravenous tranexamic acid administration in managing perioperative blood loss in patients undergoing spine surgery. J Perianesth Nurs. 2014 Dec;29(6):459-65. doi: 10.1016/j.jopan.2014.06.003. Epub 2014 Nov 20.
• Background Xiong Z, Liu J, Yi P, Wang H, Tan M. Comparison of Intravenous versus Topical Tranexamic Acid in Nondeformity Spine Surgery: A Meta-Analysis. Biomed Res Int. 2020 Mar 9;2020:7403034. doi: 10.1155/2020/7403034. eCollection 2020.
• Background Winter SF, Santaguida C, Wong J, Fehlings MG. Systemic and Topical Use of Tranexamic Acid in Spinal Surgery: A Systematic Review. Global Spine J. 2016 May;6(3):284-95. doi: 10.1055/s-0035-1563609. Epub 2015 Sep 21.
• Background Gulabi D, Yuce Y, Erkal KH, Saglam N, Camur S. The combined administration of systemic and topical tranexamic acid for total hip arthroplasty: Is it better than systemic? Acta Orthop Traumatol Turc. 2019 Jul;53(4):297-300. doi: 10.1016/j.aott.2019.03.001. Epub 2019 Apr 4.
• Background Li J, Wang L, Bai T, Liu Y, Huang Y. Combined use of intravenous and topical tranexamic acid efficiently reduces blood loss in patients aged over 60 operated with a 2-level lumbar fusion. J Orthop Surg Res. 2020 Aug 20;15(1):339. doi: 10.1186/s13018-020-01758-8.
• Background 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 May 17;344:e3054. doi: 10.1136/bmj.e3054.
• Background 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 Feb 1;110(2):350-3. doi: 10.1213/ANE.0b013e3181c92b23. Epub 2009 Dec 8.
• Background Cravens GT, Brown MJ, Brown DR, Wass CT. Antifibrinolytic therapy use to mitigate blood loss during staged complex major spine surgery: Postoperative visual color changes after tranexamic acid administration. Anesthesiology. 2006 Dec;105(6):1274-6. doi: 10.1097/00000542-200612000-00029. No abstract available.
• Background Murao S, Nakata H, Roberts I, Yamakawa K. Effect of tranexamic acid on thrombotic events and seizures in bleeding patients: a systematic review and meta-analysis. Crit Care. 2021 Nov 1;25(1):380. doi: 10.1186/s13054-021-03799-9.
• Background Mikhail C, Pennington Z, Arnold PM, Brodke DS, Chapman JR, Chutkan N, Daubs MD, DeVine JG, Fehlings MG, Gelb DE, Ghobrial GM, Harrop JS, Hoelscher C, Jiang F, Knightly JJ, Kwon BK, Mroz TE, Nassr A, Riew KD, Sekhon LH, Smith JS, Traynelis VC, Wang JC, Weber MH, Wilson JR, Witiw CD, Sciubba DM, Cho SK. Minimizing Blood Loss in Spine Surgery. Global Spine J. 2020 Jan;10(1 Suppl):71S-83S. doi: 10.1177/2192568219868475. Epub 2020 Jan 6.
• Background Montroy J, Hutton B, Moodley P, Fergusson NA, Cheng W, Tinmouth A, Lavallee LT, Fergusson DA, Breau RH. The efficacy and safety of topical tranexamic acid: A systematic review and meta-analysis. Transfus Med Rev. 2018 Feb 19:S0887-7963(17)30151-7. doi: 10.1016/j.tmrv.2018.02.003. Online ahead of print.
• Background Mallepally AR, Mahajan R, Rustagi T, Goel SA, Das K, Chhabra HS. Use of Topical Tranexamic Acid to Reduce Blood Loss in Single-Level Transforaminal Lumbar Interbody Fusion. Asian Spine J. 2020 Oct;14(5):593-600. doi: 10.31616/asj.2019.0134. Epub 2020 Mar 30.
• Background Wang F, Wang SG, Yang Q, Nan LP, Cai TC, Wu DS, Zhang L. Cytotoxicity and Effect of Topical Application of Tranexamic Acid on Human Fibroblast in Spine Surgery. World Neurosurg. 2021 Sep;153:e380-e391. doi: 10.1016/j.wneu.2021.06.125. Epub 2021 Jul 2.
• Background Schwarzkopf R, Dang P, Luu M, Mozaffar T, Gupta R. Topical tranexamic Acid does not affect electrophysiologic or neurovascular sciatic nerve markers in an animal model. Clin Orthop Relat Res. 2015 Mar;473(3):1074-82. doi: 10.1007/s11999-014-4098-4. Epub 2015 Jan 6.
• Background Ren Z, Li S, Sheng L, Zhuang Q, Li Z, Xu D, Chen X, Jiang P, Zhang X. Topical use of tranexamic acid can effectively decrease hidden blood loss during posterior lumbar spinal fusion surgery: A retrospective study. Medicine (Baltimore). 2017 Oct;96(42):e8233. doi: 10.1097/MD.0000000000008233.
• Background Sudprasert W, Tanaviriyachai T, Choovongkomol K, Jongkittanakul S, Piyapromdee U. A Randomized Controlled Trial of Topical Application of Tranexamic Acid in Patients with Thoracolumbar Spine Trauma Undergoing Long-Segment Instrumented Posterior Spinal Fusion. Asian Spine J. 2019 Feb;13(1):146-154. doi: 10.31616/asj.2018.0125. Epub 2018 Oct 24.
• Background Gybel M, Kristensen K, Roseva-Nielsen N. [Cardiac arrest caused by massive pulmonary embolism during treatment with tranexamic acid]. Ugeskr Laeger. 2013 May 13;175(20):1426-7. Danish.
• Background Taparia M, Cordingley FT, Leahy MF. Pulmonary embolism associated with tranexamic acid in severe acquired haemophilia. Eur J Haematol. 2002 May;68(5):307-9. doi: 10.1034/j.1600-0609.2002.01607.x.
• Background Krivokuca I, Lammers JW. Recurrent pulmonary embolism associated with a hemostatic drug: tranexamic acid. Clin Appl Thromb Hemost. 2011 Feb;17(1):106-7. doi: 10.1177/1076029609340902. Epub 2009 Oct 14.
• Background Colomina MJ, Contreras L, Guilabert P, Koo M, M Ndez E, Sabate A. Clinical use of tranexamic acid: evidences and controversies. Braz J Anesthesiol. 2022 Nov-Dec;72(6):795-812. doi: 10.1016/j.bjane.2021.08.022. Epub 2021 Oct 7.

Drugs

Indications