Efficacy of Topical Tranexamic Acid in Reducing Blood Loss after Laminectomy and Posterolateral Fusion of the Spine: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
Abstract
Background: Multi-level spine surgeries are associated with high bleeding during and after surgery. A majority of studies have previously evaluated the effect of tranexamic acid (TXA) in reducing bleeding with a focus on intravenous (IV) administration. The aim of the study was to evaluate the efficacy of topical TXA in decreasing bleeding after laminectomy and spinal fusion.
Methods: In this randomized, double-blinded, placebo-controlled clinical trial, 80 patients were enrolled from January 2017 to January 2019. The patients were eligible for laminectomy (2 or more levels) and posterolateral fusion with a pedicle screw. Patients were randomly divided into two equal groups; single-dose TXA (1 g/50 ml) and normal saline. Intergroup comparison was performed for the amount of bleeding during and after surgery, received packed cells, and the number of hospitalization days.
Results: The mean age of the patients was 55.51 ± 10.27 years, and 50 of them were women. 18 and 20 patients in control and TXA groups had intraoperative bleeding more than 400 ml, respectively (P ˃0.05). The only significant difference was observed in the first and second 12 hours, and total bleeding after surgery in patients who had bleeding above 400 ml (P = 0.011, P = 0.039, P = 0.015, respectively).
Conclusion: The application of topical TXA was effective in patients with high amount of hemorrhage during spine surgery for reducing the bleeding rate in the first and second 12 hours, as well as the mean total bleeding rate after surgery. It had no significant effect on total intraoperative hemorrhage, total packed cells, and total hospitalization length.
2. Huang F, Wu D, Ma G, Yin Z, Wang Q. The use of tranexamic acid to reduce blood loss and transfusion in major orthopedic surgery: A meta-analysis. J Surg Res. 2014;186(1):318-27. doi: 10.1016/j.jss.2013.08.020. [PubMed: 24075404].
3. Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013;(7):CD010562. doi: 10.1002/14651858.CD010562.pub2. [PubMed: 23881695].
4. Luo W, Sun RX, Jiang H, Ma XL. The efficacy and safety of topical administration of tranexamic acid in spine surgery: A meta-analysis. J Orthop Surg Res. 2018;13(1):96. doi: 10.1186/s13018-018-0815-0. [PubMed: 29690892]. [PubMed Central: PMC5937828].
5. 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. doi:
10.1002/14651858.CD001886.pub4. [PubMed: 21412876].
[PubMed Central: PMC4234031].
6. Elwatidy S, Jamjoom Z, Elgamal E, Zakaria A, Turkistani A, El-Dawlatly A. Efficacy and safety of prophylactic large dose of tranexamic acid in spine surgery: A prospective, randomized, double-blind, placebo-controlled study. Spine (Phila Pa 1976).
2008;33(24):2577-80.doi:10.1097/BRS.0b013e318188b9c5.
[PubMed: 19011538].
7. Sabzi F, Teimouri H, Zokai A. Myoclonus, seizure, and ventricular fibrillation after intrathecal injection of tranexamic acid. J Tehran Heart Cent. 2009;4(4):253-5. [In Persian].
8. Damji KF, Noel LP, Peterson RG, Ma PE, Clarke WN, Gilberg S, et al. Topical versus intravenous administration of tranexamic acid: A comparison of intraocular and serum concentrations in the rabbit. Can J Ophthalmol. 1998;33(6):308-13. [PubMed: 9818127].
9. Puigdellivol E, Carral ME, Moreno J, Pla-Delfina JM, Jane F. Pharmacokinetics and absolute bioavailability of intramuscular tranexamic acid in man. Int J Clin Pharmacol Ther Toxicol. 1985;23(6):298-301. [PubMed: 4018929].
10. Yang B, Li H, Wang D, He X, Zhang C, Yang P. Systematic review and meta-analysis of perioperative intravenous tranexamic acid use in spinal surgery. PLoS One. 2013;8(2):e55436. doi: 10.1371/journal.pone.0055436. [PubMed: 23424632]. [PubMed Central: PMC3570541].
11. Morgan A, Jeffrey-Smith A. BET 1: Should tranexamic acid be given to patients who are having an upper gastrointestinal bleed? Emerg Med J. 2012;29(9):773-7. doi: 10.1136/emermed-2012-201686.2. [PubMed: 22903425].
12. Molloy DO, Archbold HA, Ogonda L, McConway J, Wilson RK, Beverland DE. Comparison of topical fibrin spray and tranexamic acid on blood loss after total knee replacement: A prospective, randomised controlled trial. J Bone Joint Surg Br. 2007;89(3):306-9. doi: 10.1302/0301-620X.89B3.17565. [PubMed: 17356139].
13. Shakeri M, Salehpour F, Shokouhi G, Aeinfar K, Aghazadeh J, Mirzaei F, et al. Minimal dose of tranexamic acid is effective in reducing blood loss in complex spine surgeries: A randomized double-blind placebo controlled study. Asian Spine J. 2018;12(3):484-9. doi: 10.4184/asj.2018.12.3.484. [PubMed: 29879776]. [PubMed Central: PMC6002182].
14. Xu D, Zhuang Q, Li Z, Ren Z, Chen X, Li S. A randomized controlled trial on the effects of collagen sponge and topical tranexamic acid in posterior spinal fusion surgeries. J Orthop Surg Res. 2017;12(1):166. doi: 10.1186/s13018-017-0672-2. [PubMed: 29110696]. [PubMed Central: PMC5674845].
15. 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;6(3):284-95. doi: 10.1055/s-0035-1563609. [PubMed: 27099820]. [PubMed Central: PMC4836933].
16. Cheriyan T, Maier SP, Bianco K, Slobodyanyuk K, Rattenni RN, Lafage V, et al. Efficacy of tranexamic acid on surgical bleeding in spine surgery: A meta-analysis. Spine J. 2015;15(4):752-61. doi: 10.1016/j.spinee.2015.01.013. [PubMed: 25617507].
17. Neilipovitz DT. Tranexamic acid for major spinal surgery. Eur Spine J. 2004;13(Suppl 1):S62-S65. doi: 10.1007/s00586-004-0716-2. [PubMed: 15127250]. [PubMed Central: PMC3592185].
18. Alvarez JC, Santiveri FX, Ramos I, Vela E, Puig L, Escolano F. Tranexamic acid reduces blood transfusion in total knee arthroplasty even when a blood conservation program is applied. Transfusion. 2008;48(3):519-25. doi: 10.1111/j.1537-2995.2007.01564.x. [PubMed: 18067499].
19. Shi H, Ou Y, Jiang D, Quan Z, Zhao Z, Zhu Y. Tranexamic acid reduces perioperative blood loss of posterior lumbar surgery for stenosis or spondylolisthesis: A randomized trial. Medicine (Baltimore). 2017;96(1):e5718. doi: 10.1097/MD.0000000000005718. [PubMed: 28072709]. [PubMed Central: PMC5228669].
Files | ||
Issue | Vol 7, No 1 (2021) | |
Section | Research Articles | |
DOI | https://doi.org/10.18502/jost.v7i1.5959 | |
Keywords | ||
Tranexamic Acid Laminectomy Spine Bleeding |
Rights and permissions | |
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |