Prospective randomized controlled trial on the effectiveness of low-dose and high-dose intravenous tranexamic acid in reducing perioperative blood loss in single-level minimally invasive transforaminal lumbar interbody fusion_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

ZHANG Dongfeng ¹ ,  WU Xiaodong ² , KONG Qingquan ³ , WANG Yu ³ , ZHANG Bin ² , FENG Pin ² , WU Ye ³ , GUO Chuan ³ , LI Weilong ³

1. Department of Spine Surgery, South China Hospital of Shenzhen University, Shenzhen Guangdong, 518116, P. R. China;
2. Department of Orthopedics, Hospital of Chengdu Office of People’s Government of Tibetan Autonomous Region, Chengdu Sichuan, 610041, P. R. China;
3. Orthopedic Research Institute, Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P. R. China;

Corresponding author：

WU Xiaodong, Email: 9236247@qq.com

Keywords：

Tranexamic acid; minimally invasive transforaminal lumbar interbody fusion; blood loss; deep venous thrombosis of lower extremity

DOI：

10.7507/1002-1892.202112015

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Objective A prospective randomized controlled trial was conducted to study the effectiveness and safety of intravenous different doses tranexamic acid (TXA) in single-level unilateral minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). Methods The patients treated with single-level unilateral MIS-TLIF between September 2019 and October 2020 were enrolled and randomly classified into low-dose TXA (LD) group (n=39), high-dose TXA (HD) group (n=39), and placebo-controlled (PC) group (n=38). The LD, HD, and PC groups received intravenous TXA 20 mg/kg, TXA 50 mg/kg, the same volume of normal saline at 30 minute before skin incision after general anesthesia, respectively. There was no significant difference on baseline characteristics and preoperative laboratory results among 3 groups (P>0.05), including age, gender, body mass index, surgical segments, hematocrit (HCT), hemoglobin (HGB), prothrombin time (PT), international normalized ratio (INR), D-dimer, fibrin degradation products (FDP), activated partial prothromboplastin time (APTT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (Cr), urea. The intraoperative blood loss (IBL), postoperative drainage volume, operation time, total blood loss (TBL), hidden blood loss (HBL), blood transfusion, hematological examination indexes on the first day after operation, and the incidence of complications within 1 month were compared among the 3 groups. Results There were 3, 2, and 4 patients in the LD, HD, and PC groups who underwent autologous blood transfusion, respectively, and there was no allogeneic blood transfusion patients in the 3 groups. There was no significant difference in IBL, postoperative drainage volume, and operation time between groups (P>0.05). The TBL, HBL, and the decreased value of HGB in LD and HD groups were significantly lower than those in PC group (P<0.05), and TBL and HBL in HD group were significantly lower than those in LD group (P<0.05); the decreased value of HGB between LD group and HD group showed no significant difference (P>0.05). On the first day after operation, D-dimer in LD and HD groups were significantly lower than that in PC group (P<0.05); there was no significant difference between LD and HD groups (P>0.05). There was no significant difference in other hematological indexes between groups (P>0.05). All patients were followed up 1 month, and there was no TXA-related complication such as deep venous thrombosis of lower extremity, pulmonary embolism, and epilepsy in the 3 groups. Conclusion Intravenous administration of TXA in single-level unilateral MIS-TLIF is effective and safe in reducing postoperative TBL and HBL within 1 day in a dose-dependent manner. Also, TXA can reduce postoperative fibrinolysis markers and do not increase the risk of thrombotic events, including deep venous thrombosis and pulmonary embolism.

Citation： ZHANG Dongfeng, WU Xiaodong, KONG Qingquan, WANG Yu, ZHANG Bin, FENG Pin, WU Ye, GUO Chuan, LI Weilong. Prospective randomized controlled trial on the effectiveness of low-dose and high-dose intravenous tranexamic acid in reducing perioperative blood loss in single-level minimally invasive transforaminal lumbar interbody fusion. Chinese Journal of Reparative and Reconstructive Surgery, 2022, 36(4): 439-445. doi: 10.7507/1002-1892.202112015 Copy

1.	Hockley A, Ge D, Vasquez-Montes D, et al. Minimally invasive versus open transforaminal lumbar interbody fusion surgery: An analysis of opioids, nonopioid analgesics, and perioperative characteristics. Global Spine J, 2019, 9(6): 624-629.
2.	Foley KT, Holly LT, Schwender JD. Minimally invasive lumbar fusion. Spine (Phila Pa 1976), 2003, 28(15 Suppl): S26-S35.
3.	Yang Y, Zhang L, Liu B, et al. Hidden and overall haemorrhage following minimally invasive and open transforaminal lumbar interbody fusion. J Orthop Traumatol, 2017, 18(4): 395-400.
4.	Carlson BB, Saville P, Dowdell J, et al. Restoration of lumbar lordosis after minimally invasive transforaminal lumbar interbody fusion: a systematic review. Spine J, 2019, 19(5): 951-958.
5.	Karikari IO, Isaacs RE. Minimally invasive transforaminal lumbar interbody fusion: a review of techniques and outcomes. Spine (Phila Pa 1976), 2010, 35(26 Suppl): S294-S301.
6.	Kolev K, Longstaff C. Bleeding related to disturbed fibrinolysis. Br J Haematol, 2016, 175(1): 12-23.
7.	Ge DH, Stekas ND, Varlotta CG, et al. Comparative analysis of two transforaminal lumbar interbody fusion techniques: Open TLIF versus Wiltse MIS TLIF. Spine (Phila Pa 1976), 2019, 44(9): E555-E560.
8.	张庄, 杨曦, 汪雷, 等. 氨甲环酸在青少年脊柱矫形手术中的应用进展. 中国修复重建外科杂志, 2020, 34(11): 1468-1473.
9.	Yuan QM, Zhao ZH, Xu BS. Efficacy and safety of tranexamic acid in reducing blood loss in scoliosis surgery: a systematic review and meta-analysis. Eur Spine J, 2017, 26(1): 131-139.
10.	张少云, 肖聪, 裴福兴. 氨甲环酸在创伤骨科手术中应用的研究进展. 中国修复重建外科杂志, 2019, 33(11): 1457-1461.
11.	周宗科, 黄泽宁, 杨惠林, 等. 中国骨科手术加速康复围手术期氨甲环酸与抗凝血药应用的专家共识. 中华骨与关节外科杂志, 2019, 12(2): 81-88.
12.	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.
13.	Wong J, El Beheiry H, Rampersaud YR, et al. Tranexamic Acid reduces perioperative blood loss in adult patients having spinal fusion surgery. Anesth Analg, 2008, 107(5): 1479-1486.
14.	Kim KT, Kim CK, Kim YC, et al. The effectiveness of low-dose and high-dose tranexamic acid in posterior lumbar interbody fusion: a double-blinded, placebo-controlled randomized study. Eur Spine J, 2017, 26(11): 2851-2857.
15.	Raman T, Varlotta C, Vasquez-Montes D, et al. The use of tranexamic acid in adult spinal deformity: is there an optimal dosing strategy? Spine J, 2019, 19(10): 1690-1697.
16.	周宗科, 翁习生, 孙天胜, 等. 中国骨科手术加速康复——围术期血液管理专家共识. 中华骨与关节外科杂志, 2017, 10(1): 1-7.
17.	Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery, 1962, 51(2): 224-232.
18.	Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology, 1983, 58(3): 277-280.
19.	Li F, Li C, Xi X, et al. Distinct fusion intersegmental parameters regarding local sagittal balance provide similar clinical outcomes: a comparative study of minimally invasive versus open transforaminal lumbar interbody fusion. BMC Surg, 2020, 20(1): 97. doi: 10.1186/s12893-020-00765-0.
20.	Smorgick Y, Baker KC, Bachison CC, et al. Hidden blood loss during posterior spine fusion surgery. Spine J, 2013, 13(8): 877-881.
21.	Zhang H, Chen ZX, Sun ZM, et al. Comparison of the total and hidden blood loss in patients undergoing open and minimally invasive transforaminal lumbar interbody fusion. World Neurosurg, 2017, 107: 739-743.
22.	Feng C, Zhang Y, Chong F, et al. Establishment and implementation of an enhanced recovery after surgery (ERAS) pathway tailored for minimally invasive transforaminal lumbar interbody fusion surgery. World Neurosurg, 2019, 129: e317-e323.
23.	Zhang S, Xie J, Cao G, et al. Six-dose intravenous tranexamic acid regimen further inhibits postoperative fibrinolysis and reduces hidden blood loss following total knee arthroplasty. J Knee Surg, 2021, 34(2): 224-232.
24.	Pong RP, Leveque JA, Edwards A, et al. Effect of tranexamic acid on blood loss, d-dimer, and fibrinogen kinetics in adult spinal deformity surgery. J Bone Joint Surg (Am), 2018, 100(9): 758-764.
25.	Cao G, Xie J, Huang Z, et al. Efficacy and safety of multiple boluses of oral versus intravenous tranexamic acid at reducing blood loss after primary total knee arthroplasty without a tourniquet: A prospective randomized clinical trial. Thromb Res, 2018, 171: 68-73.
26.	Mallepally AR, Mahajan R, Rustagi T, et al. Use of topical tranexamic acid to reduce blood loss in single-level transforaminal lumbar interbody fusion. Asian Spine J, 2020, 14(5): 593-600.
27.	Sun H, Deng L, Deng J, et al. The efficacy and safety of prophylactic intravenous tranexamic acid on perioperative blood loss in patients treated with posterior lumbar interbody fusion. World Neurosurg, 2019, 125: e198-e204.
28.	Zhang Z, Wang LN, Yang X, et al. The effect of multiple-dose oral versus intravenous tranexamic acid in reducing postoperative blood loss and transfusion rate after adolescent scoliosis surgery: a randomized controlled trial. Spine J, 2021, 21(2): 312-320.
29.	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.
30.	Ko BS, Cho KJ, Kim YT, et al. Does Tranexamic acid increase the incidence of thromboembolism after spinal fusion surgery? Clin Spine Surg, 2020, 33(2): E71-E75.

1. Hockley A, Ge D, Vasquez-Montes D, et al. Minimally invasive versus open transforaminal lumbar interbody fusion surgery: An analysis of opioids, nonopioid analgesics, and perioperative characteristics. Global Spine J, 2019, 9(6): 624-629.
2. Foley KT, Holly LT, Schwender JD. Minimally invasive lumbar fusion. Spine (Phila Pa 1976), 2003, 28(15 Suppl): S26-S35.
3. Yang Y, Zhang L, Liu B, et al. Hidden and overall haemorrhage following minimally invasive and open transforaminal lumbar interbody fusion. J Orthop Traumatol, 2017, 18(4): 395-400.
4. Carlson BB, Saville P, Dowdell J, et al. Restoration of lumbar lordosis after minimally invasive transforaminal lumbar interbody fusion: a systematic review. Spine J, 2019, 19(5): 951-958.
5. Karikari IO, Isaacs RE. Minimally invasive transforaminal lumbar interbody fusion: a review of techniques and outcomes. Spine (Phila Pa 1976), 2010, 35(26 Suppl): S294-S301.
6. Kolev K, Longstaff C. Bleeding related to disturbed fibrinolysis. Br J Haematol, 2016, 175(1): 12-23.
7. Ge DH, Stekas ND, Varlotta CG, et al. Comparative analysis of two transforaminal lumbar interbody fusion techniques: Open TLIF versus Wiltse MIS TLIF. Spine (Phila Pa 1976), 2019, 44(9): E555-E560.
8. 张庄, 杨曦, 汪雷, 等. 氨甲环酸在青少年脊柱矫形手术中的应用进展. 中国修复重建外科杂志, 2020, 34(11): 1468-1473.
9. Yuan QM, Zhao ZH, Xu BS. Efficacy and safety of tranexamic acid in reducing blood loss in scoliosis surgery: a systematic review and meta-analysis. Eur Spine J, 2017, 26(1): 131-139.
10. 张少云, 肖聪, 裴福兴. 氨甲环酸在创伤骨科手术中应用的研究进展. 中国修复重建外科杂志, 2019, 33(11): 1457-1461.
11. 周宗科, 黄泽宁, 杨惠林, 等. 中国骨科手术加速康复围手术期氨甲环酸与抗凝血药应用的专家共识. 中华骨与关节外科杂志, 2019, 12(2): 81-88.
12. 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.
13. Wong J, El Beheiry H, Rampersaud YR, et al. Tranexamic Acid reduces perioperative blood loss in adult patients having spinal fusion surgery. Anesth Analg, 2008, 107(5): 1479-1486.
14. Kim KT, Kim CK, Kim YC, et al. The effectiveness of low-dose and high-dose tranexamic acid in posterior lumbar interbody fusion: a double-blinded, placebo-controlled randomized study. Eur Spine J, 2017, 26(11): 2851-2857.
15. Raman T, Varlotta C, Vasquez-Montes D, et al. The use of tranexamic acid in adult spinal deformity: is there an optimal dosing strategy? Spine J, 2019, 19(10): 1690-1697.
16. 周宗科, 翁习生, 孙天胜, 等. 中国骨科手术加速康复——围术期血液管理专家共识. 中华骨与关节外科杂志, 2017, 10(1): 1-7.
17. Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery, 1962, 51(2): 224-232.
18. Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology, 1983, 58(3): 277-280.
19. Li F, Li C, Xi X, et al. Distinct fusion intersegmental parameters regarding local sagittal balance provide similar clinical outcomes: a comparative study of minimally invasive versus open transforaminal lumbar interbody fusion. BMC Surg, 2020, 20(1): 97. doi: 10.1186/s12893-020-00765-0.
20. Smorgick Y, Baker KC, Bachison CC, et al. Hidden blood loss during posterior spine fusion surgery. Spine J, 2013, 13(8): 877-881.
21. Zhang H, Chen ZX, Sun ZM, et al. Comparison of the total and hidden blood loss in patients undergoing open and minimally invasive transforaminal lumbar interbody fusion. World Neurosurg, 2017, 107: 739-743.
22. Feng C, Zhang Y, Chong F, et al. Establishment and implementation of an enhanced recovery after surgery (ERAS) pathway tailored for minimally invasive transforaminal lumbar interbody fusion surgery. World Neurosurg, 2019, 129: e317-e323.
23. Zhang S, Xie J, Cao G, et al. Six-dose intravenous tranexamic acid regimen further inhibits postoperative fibrinolysis and reduces hidden blood loss following total knee arthroplasty. J Knee Surg, 2021, 34(2): 224-232.
24. Pong RP, Leveque JA, Edwards A, et al. Effect of tranexamic acid on blood loss, d-dimer, and fibrinogen kinetics in adult spinal deformity surgery. J Bone Joint Surg (Am), 2018, 100(9): 758-764.
25. Cao G, Xie J, Huang Z, et al. Efficacy and safety of multiple boluses of oral versus intravenous tranexamic acid at reducing blood loss after primary total knee arthroplasty without a tourniquet: A prospective randomized clinical trial. Thromb Res, 2018, 171: 68-73.
26. Mallepally AR, Mahajan R, Rustagi T, et al. Use of topical tranexamic acid to reduce blood loss in single-level transforaminal lumbar interbody fusion. Asian Spine J, 2020, 14(5): 593-600.
27. Sun H, Deng L, Deng J, et al. The efficacy and safety of prophylactic intravenous tranexamic acid on perioperative blood loss in patients treated with posterior lumbar interbody fusion. World Neurosurg, 2019, 125: e198-e204.
28. Zhang Z, Wang LN, Yang X, et al. The effect of multiple-dose oral versus intravenous tranexamic acid in reducing postoperative blood loss and transfusion rate after adolescent scoliosis surgery: a randomized controlled trial. Spine J, 2021, 21(2): 312-320.
29. 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.
30. Ko BS, Cho KJ, Kim YT, et al. Does Tranexamic acid increase the incidence of thromboembolism after spinal fusion surgery? Clin Spine Surg, 2020, 33(2): E71-E75.

Chinese Journal of Reparative and Reconstructive Surgery

Prospective randomized controlled trial on the effectiveness of low-dose and high-dose intravenous tranexamic acid in reducing perioperative blood loss in single-level minimally invasive transforaminal lumbar interbody fusion

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