Efficacy and safety of a loading high-dose tranexamic acid followed by postoperative five doses in total hip arthroplasty: A randomized controlled trial_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

CUI Danli ¹ , LEI Yiting ² , XU Hong ² , HUANG Qiang ² ,  PEI Fuxing ²

1. Key Laboratory of Transplant Engineering and Immunology, Ministry of Health, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China;
2. Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China;

Corresponding author：

PEI Fuxing, Email: peifux@126.com

Keywords：

Tranexamic acid; total hip arthroplasty; blood loss; perioperative period

DOI：

10.7507/1002-1892.201902075

Video：

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Objective To evaluate the efficacy and safety of a loading high-dose tranexamic acid (TXA) followed by postoperative 5 doses in total hip arthroplasty (THA) by a randomized controlled trial.Methods Seventy-two patients who underwent primary unilateral THA between December 2017 and March 2018 were randomly divided into two groups (36 patients in each group). A single dose of 20 mg/kg TXA was administered intravenously before 5-10 minutes of operation in group A; and a single dose of 40 mg/kg TXA was administered intravenously in group B at the same time point. All patients received 5 doses of 1 g TXA at 3, 6, 12, 18, and 24 hours after the first dose. There was no significant difference in gender, age, weight, height, body mass index, disease type, and combined medical diseases between the two groups (P>0.05). Total blood loss (TBL), lowest postoperative hemoglobin (Hb) level, fibrinolysis parameters [fibrin (ogen) degradation products (FDP), D-dimer], inflammatory factors [C-reaction protein (CRP), interleukin-6 (IL-6)], adverse events (thrombosis, pulmonary embolism) were recorded and compared between groups.Results The TBL was significantly lower in group B than in group A (P<0.05). Furthermore, the lowest postoperative Hb level was significantly higher in group B than in group A (P<0.05). There was no significant difference in FDP and D-dimer before operation between the two groups (P>0.05). The levels of FDP and D-dimer were significantly lower in group B than in group A at 12 and 36 hours postoperatively (P<0.05). There was no significant difference in CRP and IL-6 before operation between the two groups (P>0.05). The levels of CRP and IL-6 were significant lower in group B than in group A at 12, 24, and 36 hours postoperatively (P<0.05). There was no significant difference at 14 days (P>0.05). There were 2 patients with intramuscular venous thrombosis in group A and 1 in group B after operation, and there was no significant difference in the incidence of embolic events (P>0.05). No deep venous thrombosis or pulmonary embolism occurred in all groups.Conclusion A loading high-dose TXA followed by postoperative 5 doses can further reduce the blood loss, provide additional fibrinolysis and inflammation control in THA, without increasing the risk of embolic events.

Citation： CUI Danli, LEI Yiting, XU Hong, HUANG Qiang, PEI Fuxing. Efficacy and safety of a loading high-dose tranexamic acid followed by postoperative five doses in total hip arthroplasty: A randomized controlled trial. Chinese Journal of Reparative and Reconstructive Surgery, 2019, 33(8): 935-939. doi: 10.7507/1002-1892.201902075 Copy

1.	Xie J, Hu Q, Ma J, et al. Multiple boluses of intravenous tranexamic acid to reduce hidden blood loss and the inflammatory response following enhanced-recovery primary total hip arthroplasty: a randomised clinical trial. Bone Joint J, 2017, 99-B(11): 1442-1449.
2.	龙也, 王通, 刘佳鑫, 等. 重组人促红细胞生成素联合铁剂纠正老年股骨转子间骨折患者围术期贫血的临床研究. 中国修复重建外科杂志, 2019, 33(6): 662-665.
3.	李锐博, 尹诗九, 钟航, 等. 静脉联合关节腔内注射氨甲环酸后引流管夹闭时间对人工全膝关节置换术后失血量的影响及安全性评价. 中国修复重建外科杂志, 2017, 31(4): 417-421.
4.	吴俊, 李广翼, 陈云苏, 等. 三种氨甲环酸联合用药方案在初次人工全膝关节置换术中的疗效比较. 中国修复重建外科杂志, 2018, 32(11): 1397-1401.
5.	Lee QJ, Chang WY, Wong YC. Blood-sparing efficacy of oral tranexamic acid in primary total hip arthroplasty. J Arthroplasty, 2017, 32(1): 139-142.
6.	Kayupov E, Fillingham YA, Okroj K, et al. Oral and intravenous tranexamic acid are equivalent at reducing blood loss following total hip arthroplasty: a randomized controlled trial. J Bone Joint Surg (Am), 2017, 99(5): 373-378.
7.	Zhang P, Liang Y, Chen P, et al. Combined application versus topical and intravenous application of tranexamic acid following primary total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord, 2017, 18(1): 90.
8.	Lin ZX, Woolf SK. Safety, efficacy, and cost-effectiveness of tranexamic acid in orthopedic surgery. Orthopedics, 2016, 39(2): 119-130.
9.	Maniar RN, Kumar G, Singhi T, et al. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res, 2012, 470(9): 2605-2612.
10.	Jain NP, Nisthane PP, Shah NA. Combined administration of systemic and topical tranexamic acid for total knee arthroplasty: Can it be a better regimen and yet safe? A randomized controlled trial. J Arthroplasty, 2016, 31(2): 542-547.
11.	Lei YT, Huang Q, Huang Z, et al. Multiple-dose intravenous tranexamic acid further reduces hidden blood loss after total hip arthroplasty: A randomized controlled trial. J Arthroplasty, 2018, 33(9): 2940-2945.
12.	Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology, 1983, 58(3): 277-280.
13.	Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery, 1962, 51(2): 224-232.
14.	曹国瑞, 黄强, 雷一霆, 等. 多模式血液管理在全髋关节置换术中的临床效果 1998 例回顾分析. 中国骨与关节杂志, 2017, 6(12): 889-893.
15.	Huang Z, Huang C, Xie J, et al. Analysis of a large data set to identify predictors of blood transfusion in primary total hip and knee arthroplasty. Transfusion, 2018, 58(8): 1855-1862.
16.	Hogan CA, Golightly LK, Phong S, et al. Perioperative blood loss in total hip and knee arthroplasty: Outcomes associated with intravenous tranexamic acid use in an academic medical center. Sage Open Medicine, 2016, 4. DOI: 10.1177/2050312116637024.
17.	Goobie SM. Tranexamic acid: still far to go. Br J Anaesth, 2017, 118(3): 293-295.
18.	Benoni G, Lethagen S, Fredin H. The effect of tranexamic acid on local and plasma fibrinolysis during total knee arthroplasty. Thromb Res, 1997, 85(3): 195-206.
19.	Fiechtner BK, Nuttall GA, Johnson ME, et al. Plasma tranexamic acid concentrations during cardiopulmonary bypass. Anesth Analg, 2001, 92(5): 1131-1136.
20.	Reina N, Fennema P, Hourlier H. The impact of mild peri-operative hypothermia on the effectiveness of tranexamic acid in total hip arthroplasty. Int Orthop, 2017, 41(1): 55-60.
21.	Lin JD, Lenke LG, Shillingford JN, et al. Safety of a high-dose tranexamic acid protocol in complex adult spinal deformity: Analysis of 100 consecutive cases. Spine Deform, 2018, 6(2): 189-194.
22.	Jiménez JJ, Iribarren JL, Brouard M, et al. Safety and effectiveness of two treatment regimes with tranexamic acid to minimize inflammatory response in elective cardiopulmonary bypass patients: a randomized double-blind, dose-dependent, phase Ⅳ clinical trial. J Cardiothorac Surg, 2011, 6: 138.
23.	Erroi L, Montaruli B, Camarda V, et al. Duration of post-operative fibrinolysis and thrombotic risk after tranexamic acid administration in hip and knee prosthesis interventions. Biochimica Clinica, 2017, 41(3): 235-238.
24.	Blanié A, Bellamy L, Rhayem Y, et al. Duration of postoperative fibrinolysis after total hip or knee replacement: a laboratory follow-up study. Thromb Res, 2013, 131(1): e6-e11.
25.	谢锦伟, 姚欢, 岳辰, 等. 初次髋、膝关节置换术后纤溶变化. 中国矫形外科杂志, 2016, 24(10): 931-936.
26.	雷一霆, 谢锦伟, 曹国瑞, 等. THA 围手术期多次应用氨甲环酸的效果. 中国矫形外科杂志, 2017, 25(23): 2134-2138.
27.	Lin Z, Xiaoyi Z. Tranexamic acid-associated seizures: A meta-analysis. Seizure, 2016, 36: 70-73.
28.	张少云, 曹国瑞, 黄强, 等. 影响人工全膝关节置换术后血清 IL-6 水平的危险因素分析. 中国修复重建外科杂志, 2018, 32(8): 1001-1005.
29.	Robson SC, Shephard EG, Kirsch RE. Fibrin degradation product D-dimer induces the synthesis and release of biologically active IL-1 beta, IL-6 and plasminogen activator inhibitors from monocytes in vitro. Br J Haematol, 1994, 86(2): 322-326.
30.	Gandhi R, Evans HM, Mahomed SR, et al. Tranexamic acid and the reduction of blood loss in total knee and hip arthroplasty: a meta-analysis. BMC Res Notes, 2013, 6: 184.

1. Xie J, Hu Q, Ma J, et al. Multiple boluses of intravenous tranexamic acid to reduce hidden blood loss and the inflammatory response following enhanced-recovery primary total hip arthroplasty: a randomised clinical trial. Bone Joint J, 2017, 99-B(11): 1442-1449.
2. 龙也, 王通, 刘佳鑫, 等. 重组人促红细胞生成素联合铁剂纠正老年股骨转子间骨折患者围术期贫血的临床研究. 中国修复重建外科杂志, 2019, 33(6): 662-665.
3. 李锐博, 尹诗九, 钟航, 等. 静脉联合关节腔内注射氨甲环酸后引流管夹闭时间对人工全膝关节置换术后失血量的影响及安全性评价. 中国修复重建外科杂志, 2017, 31(4): 417-421.
4. 吴俊, 李广翼, 陈云苏, 等. 三种氨甲环酸联合用药方案在初次人工全膝关节置换术中的疗效比较. 中国修复重建外科杂志, 2018, 32(11): 1397-1401.
5. Lee QJ, Chang WY, Wong YC. Blood-sparing efficacy of oral tranexamic acid in primary total hip arthroplasty. J Arthroplasty, 2017, 32(1): 139-142.
6. Kayupov E, Fillingham YA, Okroj K, et al. Oral and intravenous tranexamic acid are equivalent at reducing blood loss following total hip arthroplasty: a randomized controlled trial. J Bone Joint Surg (Am), 2017, 99(5): 373-378.
7. Zhang P, Liang Y, Chen P, et al. Combined application versus topical and intravenous application of tranexamic acid following primary total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord, 2017, 18(1): 90.
8. Lin ZX, Woolf SK. Safety, efficacy, and cost-effectiveness of tranexamic acid in orthopedic surgery. Orthopedics, 2016, 39(2): 119-130.
9. Maniar RN, Kumar G, Singhi T, et al. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res, 2012, 470(9): 2605-2612.
10. Jain NP, Nisthane PP, Shah NA. Combined administration of systemic and topical tranexamic acid for total knee arthroplasty: Can it be a better regimen and yet safe? A randomized controlled trial. J Arthroplasty, 2016, 31(2): 542-547.
11. Lei YT, Huang Q, Huang Z, et al. Multiple-dose intravenous tranexamic acid further reduces hidden blood loss after total hip arthroplasty: A randomized controlled trial. J Arthroplasty, 2018, 33(9): 2940-2945.
12. Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology, 1983, 58(3): 277-280.
13. Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery, 1962, 51(2): 224-232.
14. 曹国瑞, 黄强, 雷一霆, 等. 多模式血液管理在全髋关节置换术中的临床效果 1998 例回顾分析. 中国骨与关节杂志, 2017, 6(12): 889-893.
15. Huang Z, Huang C, Xie J, et al. Analysis of a large data set to identify predictors of blood transfusion in primary total hip and knee arthroplasty. Transfusion, 2018, 58(8): 1855-1862.
16. Hogan CA, Golightly LK, Phong S, et al. Perioperative blood loss in total hip and knee arthroplasty: Outcomes associated with intravenous tranexamic acid use in an academic medical center. Sage Open Medicine, 2016, 4. DOI: 10.1177/2050312116637024.
17. Goobie SM. Tranexamic acid: still far to go. Br J Anaesth, 2017, 118(3): 293-295.
18. Benoni G, Lethagen S, Fredin H. The effect of tranexamic acid on local and plasma fibrinolysis during total knee arthroplasty. Thromb Res, 1997, 85(3): 195-206.
19. Fiechtner BK, Nuttall GA, Johnson ME, et al. Plasma tranexamic acid concentrations during cardiopulmonary bypass. Anesth Analg, 2001, 92(5): 1131-1136.
20. Reina N, Fennema P, Hourlier H. The impact of mild peri-operative hypothermia on the effectiveness of tranexamic acid in total hip arthroplasty. Int Orthop, 2017, 41(1): 55-60.
21. Lin JD, Lenke LG, Shillingford JN, et al. Safety of a high-dose tranexamic acid protocol in complex adult spinal deformity: Analysis of 100 consecutive cases. Spine Deform, 2018, 6(2): 189-194.
22. Jiménez JJ, Iribarren JL, Brouard M, et al. Safety and effectiveness of two treatment regimes with tranexamic acid to minimize inflammatory response in elective cardiopulmonary bypass patients: a randomized double-blind, dose-dependent, phase Ⅳ clinical trial. J Cardiothorac Surg, 2011, 6: 138.
23. Erroi L, Montaruli B, Camarda V, et al. Duration of post-operative fibrinolysis and thrombotic risk after tranexamic acid administration in hip and knee prosthesis interventions. Biochimica Clinica, 2017, 41(3): 235-238.
24. Blanié A, Bellamy L, Rhayem Y, et al. Duration of postoperative fibrinolysis after total hip or knee replacement: a laboratory follow-up study. Thromb Res, 2013, 131(1): e6-e11.
25. 谢锦伟, 姚欢, 岳辰, 等. 初次髋、膝关节置换术后纤溶变化. 中国矫形外科杂志, 2016, 24(10): 931-936.
26. 雷一霆, 谢锦伟, 曹国瑞, 等. THA 围手术期多次应用氨甲环酸的效果. 中国矫形外科杂志, 2017, 25(23): 2134-2138.
27. Lin Z, Xiaoyi Z. Tranexamic acid-associated seizures: A meta-analysis. Seizure, 2016, 36: 70-73.
28. 张少云, 曹国瑞, 黄强, 等. 影响人工全膝关节置换术后血清 IL-6 水平的危险因素分析. 中国修复重建外科杂志, 2018, 32(8): 1001-1005.
29. Robson SC, Shephard EG, Kirsch RE. Fibrin degradation product D-dimer induces the synthesis and release of biologically active IL-1 beta, IL-6 and plasminogen activator inhibitors from monocytes in vitro. Br J Haematol, 1994, 86(2): 322-326.
30. Gandhi R, Evans HM, Mahomed SR, et al. Tranexamic acid and the reduction of blood loss in total knee and hip arthroplasty: a meta-analysis. BMC Res Notes, 2013, 6: 184.

Chinese Journal of Reparative and Reconstructive Surgery

Efficacy and safety of a loading high-dose tranexamic acid followed by postoperative five doses in total hip arthroplasty: A randomized controlled trial

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