Efficacy and safety of tranexamic acid sequential rivaroxaban on blood loss in elderly patients during lumbar interbody fusion_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

YANG Xiaowei , HAO Dingjun , WANG Xiaodong , GAO Wenjie ,  HUI Hao

Department of Spine Surgery, Honghui Hospital, Xi’an Jiaotong University, Xi’an Shaanxi, 710054, P.R.China;

Corresponding?author：

HUI Hao, Email: hhjzjs@163.com

Keywords：

Lumbar interbody fusion; tranexamic acid; rivaroxaban; blood loss; thrombosis; perioperative period; the elderly

DOI：

10.7507/1002-1892.202002041

Video：

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Objective To investigate the effect and safety of tranexamic acid sequential rivaroxaban on perioperative blood loss and preventing thrombosis for elderly patients during lumbar interbody fusion (LIF) with a prospective randomized controlled study.Methods Between April and October 2019, the elderly patients with lumbar degenerative diseases requiring LIF were included in the study, among which were 80 patients met the selection criteria. According to the antifibrinolysis and anticoagulation protocols, they were randomly divided into a tranexamic acid sequential rivaroxaban group (trial group) and a simple rivaroxaban group (control group) on average. Finally, 69 patients (35 in the trial group and 34 in the control group) were included for comparison. There was no significant difference in general data (P>0.05) such as gender, age, body mass index, disease duration, diseased segment, type of disease, and preoperative hemoglobin between the two groups. The operation time, intraoperative blood loss, drainage within 3 days after operation, perioperative total blood loss, and proportion of blood transfusion patients were compared between the two groups, as well as postoperative venous thrombosis of lower extremities, pulmonary embolism, and bleeding-related complications.Results The operations of the two groups completed successfully, and there was no significant difference in the operation time (P>0.05); the intraoperative blood loss, drainage within 3 days after operation, and perioperative total blood loss in the trial group were significantly lower than those in the control group (P<0.05). The proportion of blood transfusion patients in the trial group was 25.71% (9/35), which was significantly lower than that in the control group [52.94% (18/34)] (χ²=5.368, P=0.021). Postoperative incision bleeding occurred in 4 cases of the trial group and 3 cases of the control group, and there was no significant difference in bleeding-related complications between the two groups (P=1.000). There was 1 case of venous thrombosis of the lower extremities in each group after operation, and there was no significant difference in the incidence between the two groups (P=1.000). Besides, no pulmonary embolism occurred in the two groups.Conclusion Perioperative use of tranexamic acid sequential rivaroxaban in elderly LIF patients can effectively reduce the amount of blood loss and the proportion of blood transfusion patients without increasing the risk of postoperative thrombosis.

Citation： YANG Xiaowei, HAO Dingjun, WANG Xiaodong, GAO Wenjie, HUI Hao. Efficacy and safety of tranexamic acid sequential rivaroxaban on blood loss in elderly patients during lumbar interbody fusion. Chinese Journal of Reparative and Reconstructive Surgery, 2020, 34(9): 1158-1162. doi: 10.7507/1002-1892.202002041 Copy

1.	Li Y, Zheng S, Wu Y, et al. Trends of surgical treatment for spinal degenerative disease in China: A cohort of 37, 897 inpatients from 2003 to 2016. Clin Interv Aging, 2019, 14: 361-366.
2.	Fehlings MG, Tetreault L, Nater A, et al. The aging of the global population: The changing epidemiology of disease and spinal disorders. Neurosurgery, 2015, 77 Suppl 4: S1-S5.
3.	Martin BI, Mirza SK, Spina N, et al. Trends in lumbar fusion procedure rates and associated hospital costs for degenerative spinal diseases in the united states, 2004 to 2015. Spine (Phila Pa 1976), 2019, 44(5): 369-376.
4.	Wen L, Jin D, Xie W, et al. Hidden blood loss in posterior lumbar fusion surgery: An analysis of risk factors. Clin Spine Surg, 2018, 31(4): 180-184.
5.	Xu D, Ren Z, Chen X, et al. The further exploration of hidden blood loss in posterior lumbar fusion surgery. Orthop Traumatol Surg Res, 2017, 103(4): 527-530.
6.	Wei J, Li W, Pei Y, et al. Clinical analysis of preoperative risk factors for the incidence of deep venous thromboembolism in patients undergoing posterior lumbar interbody fusion. J Orthop Surg Res, 2016, 11(1): 68.
7.	Slattery C, Kark J, Wagner T, et al. The use of tranexamic acid to reduce surgical blood loss: a review basic science, subspecialty studies, and the evolution of use in spine deformity surgery. Clin Spine Surg, 2019, 32(2): 46-50.
8.	Zhang Y, Liu H, He F, et al. Does tranexamic acid improve bleeding, transfusion, and hemoglobin level in patients undergoing multi-level spine surgery? A systematic review and meta-analysis. World Neurosurg, 2019, 127: 289-301.
9.	Lu VM, Ho YT, Nambiar M, et al. The perioperative efficacy and safety of antifibrinolytics in adult spinal fusion surgery: A systematic review and meta-analysis. Spine (Phila Pa 1976), 2018, 43(16): E949-E958.
10.	Glassberg MB, Lachiewicz PF. Changing patterns of anticoagulation after total hip arthroplasty in the united states: Frequency of deep vein thrombosis, pulmonary embolism, and complications with rivaroxaban and warfarin. J Arthroplasty, 2019, 34(8): 1793-1801.
11.	Clavé A, Gérard R, Lacroix J, et al. A randomized, double-blind, placebo-controlled trial on the efficacy of tranexamic acid combined with rivaroxaban thromboprophylaxis in reducing blood loss after primary cementless total hip arthroplasty. Bone Joint J, 2019, 101-B(2): 207-212.
12.	Khan M, Jehan F, O’Keeffe T, et al. Oral Xa inhibitors versus low molecular weight heparin for thromboprophylaxis after nonoperative spine trauma. J Surg Res, 2018, 232: 82-87.
13.	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 randomized clinical trial. Bone Joint J, 2017, 99-B(11): 1442-1449.
14.	Uddin OM, Haque R, Sugrue PA, et al. Cost minimization in treatment of adult degenerative scoliosis. J Neurosurg Spine, 2015, 23(6): 798-806.
15.	孫浩林, 越雷, 王詩軍, 等. 腰椎后路長節段手術加速康復外科實施流程專家共識. 中華骨與關節外科雜志, 2019, 12(8): 572-583.
16.	Chakravarthy VB, Yokoi H, Coughlin DJ, et al. Development and implementation of a comprehensive spine surgery enhanced recovery after surgery protocol: the Cleveland Clinic experience. Neurosurg Focus, 2019, 46(4): E11.
17.	孫天勝, 沈建雄, 劉忠軍, 等. 中國脊柱手術加速康復—圍術期管理策略專家共識. 中華骨與關節外科雜志, 2017, 10(4): 271-279.
18.	Qureshi R, Puvanesarajah V, Jain A, et al. Perioperative management of blood loss in spine surgery. Clin Spine Surg, 2017, 30(9): 383-388.
19.	Sehat KR, Evans R, Newman JH. How much blood is really lost in total knee arthroplasty? Correct blood loss management should take hidden loss into account. Knee, 2000, 7(3): 151-155.
20.	Weber B, Seal A, McGirr J, et al. Case series of elective instrumented posterior lumbar spinal fusions demonstrating a low incidence of venous thromboembolism. ANZ J Surg, 2016, 86(10): 796-800.
21.	Yang SD, Liu H, Sun YP, et al. Prevalence and risk factors of deep vein thrombosis in patients after spine surgery: A retrospective case-cohort study. Sci Rep, 2015, 5(1): 11834.
22.	周宗科, 黃澤宇, 楊惠林, 等. 中國骨科手術加速康復圍手術期氨甲環酸與抗凝血藥應用的專家共識. 中華骨與關節外科雜志, 2019, 12(2): 81-88.
23.	Kepler CK, McKenzie J, Kreitz T, et al. Venous thromboembolism prophylaxis in spine surgery. J Am Acad Orthop Surg, 2018, 26(14): 489-500.
24.	Dargazanli C, Lonjon N, Gras-Combe G. Nontraumatic spinal subdural hematoma complicating direct factor Ⅹa inhibitor treatment (rivaroxaban): A challenging management. Eur Spine J, 2016, 25(Suppl 1): 100-103.
25.	Castillo JM, Afanador HF, Manjarrez E, et al. Non-traumatic spontaneous spinal subdural hematoma in a patient with non-valvular atrial fibrillation during treatment with rivaroxaban. Am J Case Rep, 2015, 16: 377-381.
26.	Zaarour M, Hassan S, Thumallapally N, et al. Rivaroxaban-induced nontraumatic spinal subdural hematoma: An uncommon yet life-threatening complication. Case Rep Hematol, 2015, 2015: 275380.
27.	Rahimizadeh A, Malekmohammadi Z, Williamson WL, et al. Rivaroxaban-induced acute cervical spine epidural hematoma: report of a case and review. Surg Neurol Int, 2019, 10: 210.
28.	Meng B, Ma J, Liu Z, et al. Efficacy and safety of tranexamic acid combined with rivaroxaban in primary total knee arthroplasty: a meta-analysis of randomized controlled trials. Journal of Investigative Surgery, 2019, 26: 1-10.
29.	Wang JW, Chen B, Lin PC, et al. The efficacy of combined use of rivaroxaban and tranexamic acid on blood conservation in minimally invasive total knee arthroplasty a double-blind randomized, controlled trial. J Arthroplasty, 2017, 32(3): 801-806.
30.	Yen SH, Lin PC, Chen B, et al. Topical tranexamic acid reduces blood loss in minimally invasive total knee arthroplasty receiving rivaroxaban. Biomed Res Int, 2017, 2017: 9105645.
31.	Colomina MJ, Koo M, Basora M, et al. Intraoperative tranexamic acid use in major spine surgery in adults: a multicentre, randomized, placebo-controlled trial. Br J Anaesth, 2017, 118(3): 380-390.
32.	Yuan Q, Zhao Z, Xu B. Efficacy and safety of tranexamic acid in reducing blood loss in scoliosis surgery: a systematic review and meta-analysis. European Spine Journal, 2017, 26(1): 131-139.
33.	Hui S, Xu D, Ren Z, et al. Can tranexamic acid conserve blood and save operative time in spinal surgeries? A meta-analysis. Spine J, 2018, 18(8): 1325-1337.
34.	Gong M, Liu G, Chen L, et al. The efficacy and safety of intravenous tranexamic acid in reducing surgical blood loss in posterior lumbar interbody fusion for the adult: A systematic review and a meta-analysis. World Neurosurgery, 2019, 122: 559-568.
35.	崔丹荔, 雷一霆, 許宏, 等. 人工全髖關節置換術中首次大劑量聯合術后五次靜脈應用氨甲環酸的前瞻性臨床研究. 中國修復重建外科雜志, 2019, 33(8): 935-939.
36.	Myles PS, Smith JA, Forbes A, et al. Tranexamic acid in patients undergoing coronary-artery surgery. N Engl J Med, 2017, 376(2): 136-148.
37.	Lin Z, Xiaoyi Z. Tranexamic acid-associated seizures: A meta-analysis. Seizure, 2016, 36: 70-73.
38.	Lecker I, Wang DS, Whissell PD, et al. Tranexamic acid-associated seizures: Causes and treatment. Ann Neurol, 2016, 79(1): 18-26.
39.	吳俊, 李廣翼, 陳云蘇, 等. 三種氨甲環酸聯合用藥方案在初次人工全膝關節置換術中的療效比較. 中國修復重建外科雜志, 2018, 32(11): 1397-1401.

1. Li Y, Zheng S, Wu Y, et al. Trends of surgical treatment for spinal degenerative disease in China: A cohort of 37, 897 inpatients from 2003 to 2016. Clin Interv Aging, 2019, 14: 361-366.
2. Fehlings MG, Tetreault L, Nater A, et al. The aging of the global population: The changing epidemiology of disease and spinal disorders. Neurosurgery, 2015, 77 Suppl 4: S1-S5.
3. Martin BI, Mirza SK, Spina N, et al. Trends in lumbar fusion procedure rates and associated hospital costs for degenerative spinal diseases in the united states, 2004 to 2015. Spine (Phila Pa 1976), 2019, 44(5): 369-376.
4. Wen L, Jin D, Xie W, et al. Hidden blood loss in posterior lumbar fusion surgery: An analysis of risk factors. Clin Spine Surg, 2018, 31(4): 180-184.
5. Xu D, Ren Z, Chen X, et al. The further exploration of hidden blood loss in posterior lumbar fusion surgery. Orthop Traumatol Surg Res, 2017, 103(4): 527-530.
6. Wei J, Li W, Pei Y, et al. Clinical analysis of preoperative risk factors for the incidence of deep venous thromboembolism in patients undergoing posterior lumbar interbody fusion. J Orthop Surg Res, 2016, 11(1): 68.
7. Slattery C, Kark J, Wagner T, et al. The use of tranexamic acid to reduce surgical blood loss: a review basic science, subspecialty studies, and the evolution of use in spine deformity surgery. Clin Spine Surg, 2019, 32(2): 46-50.
8. Zhang Y, Liu H, He F, et al. Does tranexamic acid improve bleeding, transfusion, and hemoglobin level in patients undergoing multi-level spine surgery? A systematic review and meta-analysis. World Neurosurg, 2019, 127: 289-301.
9. Lu VM, Ho YT, Nambiar M, et al. The perioperative efficacy and safety of antifibrinolytics in adult spinal fusion surgery: A systematic review and meta-analysis. Spine (Phila Pa 1976), 2018, 43(16): E949-E958.
10. Glassberg MB, Lachiewicz PF. Changing patterns of anticoagulation after total hip arthroplasty in the united states: Frequency of deep vein thrombosis, pulmonary embolism, and complications with rivaroxaban and warfarin. J Arthroplasty, 2019, 34(8): 1793-1801.
11. Clavé A, Gérard R, Lacroix J, et al. A randomized, double-blind, placebo-controlled trial on the efficacy of tranexamic acid combined with rivaroxaban thromboprophylaxis in reducing blood loss after primary cementless total hip arthroplasty. Bone Joint J, 2019, 101-B(2): 207-212.
12. Khan M, Jehan F, O’Keeffe T, et al. Oral Xa inhibitors versus low molecular weight heparin for thromboprophylaxis after nonoperative spine trauma. J Surg Res, 2018, 232: 82-87.
13. 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 randomized clinical trial. Bone Joint J, 2017, 99-B(11): 1442-1449.
14. Uddin OM, Haque R, Sugrue PA, et al. Cost minimization in treatment of adult degenerative scoliosis. J Neurosurg Spine, 2015, 23(6): 798-806.
15. 孫浩林, 越雷, 王詩軍, 等. 腰椎后路長節段手術加速康復外科實施流程專家共識. 中華骨與關節外科雜志, 2019, 12(8): 572-583.
16. Chakravarthy VB, Yokoi H, Coughlin DJ, et al. Development and implementation of a comprehensive spine surgery enhanced recovery after surgery protocol: the Cleveland Clinic experience. Neurosurg Focus, 2019, 46(4): E11.
17. 孫天勝, 沈建雄, 劉忠軍, 等. 中國脊柱手術加速康復—圍術期管理策略專家共識. 中華骨與關節外科雜志, 2017, 10(4): 271-279.
18. Qureshi R, Puvanesarajah V, Jain A, et al. Perioperative management of blood loss in spine surgery. Clin Spine Surg, 2017, 30(9): 383-388.
19. Sehat KR, Evans R, Newman JH. How much blood is really lost in total knee arthroplasty? Correct blood loss management should take hidden loss into account. Knee, 2000, 7(3): 151-155.
20. Weber B, Seal A, McGirr J, et al. Case series of elective instrumented posterior lumbar spinal fusions demonstrating a low incidence of venous thromboembolism. ANZ J Surg, 2016, 86(10): 796-800.
21. Yang SD, Liu H, Sun YP, et al. Prevalence and risk factors of deep vein thrombosis in patients after spine surgery: A retrospective case-cohort study. Sci Rep, 2015, 5(1): 11834.
22. 周宗科, 黃澤宇, 楊惠林, 等. 中國骨科手術加速康復圍手術期氨甲環酸與抗凝血藥應用的專家共識. 中華骨與關節外科雜志, 2019, 12(2): 81-88.
23. Kepler CK, McKenzie J, Kreitz T, et al. Venous thromboembolism prophylaxis in spine surgery. J Am Acad Orthop Surg, 2018, 26(14): 489-500.
24. Dargazanli C, Lonjon N, Gras-Combe G. Nontraumatic spinal subdural hematoma complicating direct factor Ⅹa inhibitor treatment (rivaroxaban): A challenging management. Eur Spine J, 2016, 25(Suppl 1): 100-103.
25. Castillo JM, Afanador HF, Manjarrez E, et al. Non-traumatic spontaneous spinal subdural hematoma in a patient with non-valvular atrial fibrillation during treatment with rivaroxaban. Am J Case Rep, 2015, 16: 377-381.
26. Zaarour M, Hassan S, Thumallapally N, et al. Rivaroxaban-induced nontraumatic spinal subdural hematoma: An uncommon yet life-threatening complication. Case Rep Hematol, 2015, 2015: 275380.
27. Rahimizadeh A, Malekmohammadi Z, Williamson WL, et al. Rivaroxaban-induced acute cervical spine epidural hematoma: report of a case and review. Surg Neurol Int, 2019, 10: 210.
28. Meng B, Ma J, Liu Z, et al. Efficacy and safety of tranexamic acid combined with rivaroxaban in primary total knee arthroplasty: a meta-analysis of randomized controlled trials. Journal of Investigative Surgery, 2019, 26: 1-10.
29. Wang JW, Chen B, Lin PC, et al. The efficacy of combined use of rivaroxaban and tranexamic acid on blood conservation in minimally invasive total knee arthroplasty a double-blind randomized, controlled trial. J Arthroplasty, 2017, 32(3): 801-806.
30. Yen SH, Lin PC, Chen B, et al. Topical tranexamic acid reduces blood loss in minimally invasive total knee arthroplasty receiving rivaroxaban. Biomed Res Int, 2017, 2017: 9105645.
31. Colomina MJ, Koo M, Basora M, et al. Intraoperative tranexamic acid use in major spine surgery in adults: a multicentre, randomized, placebo-controlled trial. Br J Anaesth, 2017, 118(3): 380-390.
32. Yuan Q, Zhao Z, Xu B. Efficacy and safety of tranexamic acid in reducing blood loss in scoliosis surgery: a systematic review and meta-analysis. European Spine Journal, 2017, 26(1): 131-139.
33. Hui S, Xu D, Ren Z, et al. Can tranexamic acid conserve blood and save operative time in spinal surgeries? A meta-analysis. Spine J, 2018, 18(8): 1325-1337.
34. Gong M, Liu G, Chen L, et al. The efficacy and safety of intravenous tranexamic acid in reducing surgical blood loss in posterior lumbar interbody fusion for the adult: A systematic review and a meta-analysis. World Neurosurgery, 2019, 122: 559-568.
35. 崔丹荔, 雷一霆, 許宏, 等. 人工全髖關節置換術中首次大劑量聯合術后五次靜脈應用氨甲環酸的前瞻性臨床研究. 中國修復重建外科雜志, 2019, 33(8): 935-939.
36. Myles PS, Smith JA, Forbes A, et al. Tranexamic acid in patients undergoing coronary-artery surgery. N Engl J Med, 2017, 376(2): 136-148.
37. Lin Z, Xiaoyi Z. Tranexamic acid-associated seizures: A meta-analysis. Seizure, 2016, 36: 70-73.
38. Lecker I, Wang DS, Whissell PD, et al. Tranexamic acid-associated seizures: Causes and treatment. Ann Neurol, 2016, 79(1): 18-26.
39. 吳俊, 李廣翼, 陳云蘇, 等. 三種氨甲環酸聯合用藥方案在初次人工全膝關節置換術中的療效比較. 中國修復重建外科雜志, 2018, 32(11): 1397-1401.

Chinese Journal of Reparative and Reconstructive Surgery

Efficacy and safety of tranexamic acid sequential rivaroxaban on blood loss in elderly patients during lumbar interbody fusion

Abstract Full text Figures/Tables Video References Cited by

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