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Efficacy and safety of tranexamic acid in posterior lumbar interbody fusion: a meta-analysis of randomized controlled trials
Luan H, Liu K, Peng C, Tian Q, Song X
Journal of orthopaedic surgery and research. 2023;18(1):14
Abstract
OBJECTIVE To evaluate the efficacy and safety of tranexamic acid (TXA) in hemostasis in patients undergoing posterior lumbar interbody fusion (PLIF) by meta-analysis. METHODS This study was registered on the International Prospective Register of Systematic Reviews (PROSPERO) (ID: CRD42022354812). The databases PubMed, Cochrane Library, Web of Science, and Embase were searched for randomized controlled trial (RCT) papers on the use of TXA in patients with PLIF from database establishment to August 2022. Two researchers screened the literature, extracted data, evaluated the risk of bias of the included studies, recorded the authors, sample size, type of study design, and TXA dose of each study, and extracted the intraoperative blood loss, number of blood transfusions, total blood loss, drainage volume, operation time, and incidence of deep venous thrombosis in each study. Meta-analysis was performed using RevMan 5.4 software provided by Cochrane Library. RESULTS A total of 14 RCTs with a total of 1681 patients were included in this study, including 836 patients in the TXA group and 845 patients in the control group. The intraoperative blood loss [mean difference (MD) = - 125.97, 95% confidence interval (CI) (- 138.56, - 113.37), P < 0.0001] and less total blood loss [MD = - 204.28, 95% CI (- 227.38, - 181.18), P < 0.00001] in TXA group were lower than the control group. Statistical significance was also observed in postoperative drainage volume [MD = - 115.03, 95% CI (- 123.89, - 106.17), P < 0.00001], operation time [MD = - 8.10, 95% CI (- 14.49, - 1.71), P = 0.01], and blood transfusion rate [odds ratio (OR) = 0.30, 95% CI (0.23, 0.39), P < 0.00001]. However, there was no statistical difference observed in the incidence of deep venous thrombosis [OR = 0.83, 95% CI (0.56, 1.21), P = 0.33]. CONCLUSION The application of TXA in PLIF can reduce intraoperative blood loss, total blood loss, drainage volume, the incidence of transfusion events, and operation time without increasing the risk of deep venous thrombosis.
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A systematic review and meta-analysis of the effects of tranexamic acid in surgical procedure for intracranial meningioma
Wijaya JH, July J, Quintero-Consuegra M, Chadid DP
Journal of neuro-oncology. 2023
Abstract
PURPOSE During intracranial meningioma surgery, surgeons experience considerable blood loss. Tranexamic acid (TXA) is used to minimize blood loss in several neurosurgical settings. However, evidence and trials are lacking. Our objective is to establish the most recent evidence on TXA safety and efficacy in intracranial meningioma surgery. METHODOLOGY Based upon Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), the authors collected fully published English literature on the administration of tranexamic acid for patients undergoing intracranial meningioma surgery using the keywords ["tranexamic acid" and "meningioma"] and its synonyms from Cochrane Central Database, the WHO International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov, and PubMed. The primary outcome of the current study was total blood loss. The secondary outcomes include individuals requiring blood transfusion, anesthesia duration, surgical duration, and complication rate. Each included studies' quality was assessed using the JADAD scale. RESULTS For qualitative and quantitative data synthesis, we included five RCTs (n = 321) with the mean age was 47.5 ± 11.9 years for the intervention group and 47.2 ± 11.9 years for the control group. Our meta-analysis showed that the administration of TXA is associated with decreased total blood loss of standardized mean difference (SMD) of -1.40 (95% CI [-2.49, -0.31]), anesthetic time SMD -0.36 (95% CI [-0.63, -0.09]), and blood transfusion requirements RR 0.58 (95% CI [0.34, 0.99]). CONCLUSIONS The current study showed that TXA was associated with reduced intraoperative blood loss and intra- and postoperative blood transfusion. However, the studies are small. More RCT studies with a greater sample size are favorable.
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Tranexamic acid use in meningioma surgery - A systematic review and meta-analysis
Clynch AL, Gillespie CS, Richardson GE, Mustafa MA, Islim AI, Keshwara SM, Bakhsh A, Kumar S, Zakaria R, Millward CP, et al
Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia. 2023;110:53-60
Abstract
Tranexamic Acid (TXA) has been used in medical and surgical practice to reduce haemorrhage. The aim of this review was to evaluate the effect of TXA use on intraoperative and postoperative outcomes of meningioma surgery. A systematic review and meta-analysis was conducted in accordance with the PRISMA statement and registered in PROSPERO (CRD42021292157). Six databases were searched up to November 2021 for phase 2-4 control trials or cohort studies, in the English language, examining TXA use during meningioma surgery. Studies ran outside of dedicated neurosurgical departments or centres were excluded. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Random effects meta-analysis were performed to delineate differences in operative and postoperative outcomes. Four studies (281 patients) were included. TXA use significantly reduced intraoperative blood loss (mean difference 315.7 mls [95% confidence interval [CI] -532.8, -98.5]). Factors not affected by TXA use were transfusion requirement (odds ratio = 0.52; 95% CI 0.27, 0.98), operation time (mean difference = -0.2 h; 95% CI -0.8, 0.4), postoperative seizures (Odds Ratio [OR] = 0.88; 95% CI 0.31, 2.53), hospital stay (mean difference = -1.2; 95% CI -3.4, 0.9) and disability after surgery (OR = 0.50; 95% CI 0.23, 1.06). The key limitations of this review were the small sample size, limited data for secondary outcomes and a lack of standardised method for measuring blood loss. TXA use reduces blood loss in meningioma surgery, but not transfusion requirement or postoperative complications. Larger trials are required to investigate the impact of TXA on patient-reported postoperative outcomes.
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Prophylactic administration of tranexamic acid combined with thromboelastography-guided hemostatic algorithm reduces allogeneic transfusion requirements during pediatric resective epilepsy surgery: A randomized controlled trial
Zhang T, Feng H, Xiao W, Li J, Liu Q, Feng X, Qi D, Fan X, Shan Y, Yu T, et al
Frontiers in pharmacology. 2022;13:916017
Abstract
Background: Intraoperative bleeding and allogeneic transfusion remain common problems in pediatric resective epilepsy surgery. Tranexamic acid (TXA) is a widely recommended antifibrinolytic drug that reduces blood loss and transfusion requirements for bleeding patients. Thromboelastography (TEG)-guided hemostatic algorithm is commonly used in bleeding management. This trial was designed to validate the efficacy of a multimodal coagulation therapy involving continuous TXA infusion with TEG-guided hemostatic algorithm in reducing allogeneic exposure risk in pediatric resective epilepsy surgery. Methods: Eighty-three children undergoing resective epilepsy surgery were randomized into a treatment group (Group T; n = 42) and a control group (Group C; n = 41). Group T received prophylactic TXA (10 mg/kg followed by 5 mg/kg/h) with TEG-guided hemostatic algorithm, whereas Group C received conventional coagulation management. The primary outcome was allogeneic transfusion rate during surgery, and the secondary outcomes were intraoperative blood loss, incidence of postoperative seizures, and thromboembolic events during hospitalization. Results: The incidence of intraoperative allogeneic transfusion reduced by 34.7% with the use of a multimodal coagulation therapy (19.0% in Group T vs. 53.7% in Group C; RR 0.355, 95% CI 0.179-0.704; p = 0.001). This was mainly triggered by a significant reduction (44.1%) in intraoperative plasma transfusion (7.1% in Group T vs. 51.2% in Group C; RR 0.139, 95% CI 0.045-0.432; p = 0.000). The risk of intraoperative RBC transfusion was lower in Group T than in Group C, but the difference was not statistically significant (14.3% in Group T vs. 29.3% in Group C; RR 0.488, 95% CI 0.202-1.177; p = 0.098). No platelets were transfused in both groups. Further, 19 (45.2%) patients in Group T received fibrinogen concentrates guided by TEG data, whereas 1 (2.4%) patient in Group C received fibrinogen concentrates empirically. There were no significant differences in estimated blood loss and postoperative seizures between the two groups, and no thromboembolic events were observed after surgery. Conclusion: Prophylactic administration of TXA combined with TEG-guided hemostatic algorithm can be an effective multimodal coagulation strategy for reducing allogeneic transfusion requirements during pediatric resective epilepsy surgery. Clinical Trial Registration: www.chictr.org.cn/index.aspx, identifier ChiCTR1800016188.
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Optimal administration strategies of tranexamic acid to minimize blood loss during spinal surgery: results of a Bayesian network meta-analysis
Cao Z, Li Q, Guo J, Li Y, Wu J
Annals of medicine. 2022;54(1):2053-2063
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Editor's Choice
Abstract
BACKGROUND Tranexamic acid (TXA) has been widely used for bleeding reduction in spinal surgery. Available evidence is insufficient to inform clinical decisions making and there remains a lack of comprehensive comparisons of dose regimens and delivery routes. This study is aimed to assess and compare different strategies regarding the involvement of TXA in spinal surgery for the optimal pathway of efficacy and safety. MATERIALS AND METHODS Cochrane Library, PubMed, Embase, Scopus and CNKI were searched for the period from January 1990 to October 2021. A random-effect model was built in the Bayesian network meta-analysis. The surface under the cumulative ranking analysis (SUCRA) and clustering rank analysis was performed for ranking the effects. RESULTS The current network meta-analysis incorporated data from 33 studies with 3302 patients. Combination administration showed superior effects on reducing intraoperative bleeding (SUCRA 78.78%, MD -129.67, 95% CI [(-222.33, -40.58)]) than placebo, and was ranked as top in reducing postoperative bleeding (SUCRA 86.91%, MD -169.92, 95% CI [(-262.71, -83.52)]), changes in haemoglobin (SUCRA 97.21%, MD -1.28, 95% CI [(-1.84, -0.73)]), and perioperative blood transfusion (SUCRA 93.23%, RR 0.10, 95% CI [(0.03, 0.25)]) simultaneously, and was shown as the best effectiveness and safety (cluster-rank value for IBL and VTE: 4057.99 and for TRF and VTE: 4802.26). CONCLUSIONS Intravenous (IV) plus topical administration of TXA appears optimal in the reduction of perioperative bleeding and blood transfusion, while the local infiltration administration is not effective for blood conservation. Further studies are required to verify the current findings.
PICO Summary
Population
Patients undergoing spinal surgery (33 studies, n= 3,302).
Intervention
Tranexamic acid (TXA).
Comparison
Various comparators: low-dose intravenous (IV), high-dose IV, low-dose topical, high-dose topical, combined use (IV plus topical), oral, local infiltration, multiple IV use before and after surgery, and placebo.
Outcome
The surface under the cumulative ranking analysis (SUCRA) and clustering rank analysis was performed for ranking the effects. Combination administration showed superior effects on reducing intraoperative bleeding (SUCRA 78.78%, weighted mean difference (MD) -129.67) than placebo, and was ranked as top in reducing postoperative bleeding (SUCRA 86.91%, MD -169.92), changes in haemoglobin (SUCRA 97.21%, MD -1.28), and perioperative blood transfusion (SUCRA 93.23%) simultaneously, and was shown as the best effectiveness and safety.
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Safety and efficacy of aprotinin versus tranexamic acid for reducing absolute blood loss and transfusion in pediatric patients undergoing craniosynostosis surgery: a randomized, double-blind, three-arm controlled trial
Ebrahim Soltani Z, Hanaei S, Dabbagh Ohadi MA, Maroufi SF, Tayebi Meybodi K, Khademi S, Yaghmaei B, Ebrahim Soltani A, Nejat F, Habibi Z
Journal of neurosurgery. Pediatrics. 2022;:1-9
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Abstract
OBJECTIVE Craniosynostosis surgery is associated with considerable blood loss and need for transfusion. Considering the lower estimated blood volume (EBV) of children compared to adults, excessive blood loss may quickly lead to hypovolemic shock. Therefore, reducing blood loss is important in craniosynostosis surgery. This study was conducted to evaluate the efficacy of aprotinin or tranexamic acid (TXA) in blood loss reduction in these patients. METHODS In the current randomized controlled trial, 90 eligible pediatric patients with craniosynostosis were randomly divided into three groups to receive either aprotinin, TXA, or no intervention. The absolute blood loss and transfusion amount were assessed for all patients both intraoperatively and 2 and 8 hours postoperatively. RESULTS Although crude values of estimated blood loss were not significantly different between groups (p = 0.162), when adjusted to the patient's weight or EBV, the values reached the significance level (p = 0.018), particularly when the aprotinin group was compared to the control group (p = 0.0154). The EBV losses 2 hours and 8 hours postoperatively significantly dropped in the TXA and aprotinin groups compared to the control group (p = 0.001 and p < 0.001, respectively). Rates of postoperative blood transfusion were significantly higher in the control group (p = 0.024). Hemoglobin and hematocrit 8 hours postoperatively were lower in the control group than in the TXA or aprotinin treatment groups (p < 0.002 and p < 0.001, respectively). There were no serious adverse events associated with the interventions in this study. CONCLUSIONS Aprotinin and TXA can reduce blood loss and blood transfusion without serious complications and adverse events in pediatric patients undergoing craniosynostosis surgery.
PICO Summary
Population
Paediatric patients undergoing craniosynostosis surgery (n= 90).
Intervention
Aprotinin (n= 30).
Comparison
Tranexamic acid (TXA, n= 30). No intervention (n= 30).
Outcome
The estimated blood volume losses 2 hours and 8 hours postoperatively significantly dropped in the TXA and aprotinin groups compared to no intervention. Rates of postoperative blood transfusion were significantly higher in the no intervention group. Haemoglobin and haematocrit 8 hours postoperatively were lower in the no intervention group than in the TXA or aprotinin treatment groups.
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Is TXA beneficial in open spine surgery? And its effects vary by dosage, age, sites, and locations: A meta-analysis of randomized controlled trials
Liu ZG, Yang F, Zhu YH, Liu GC, Zhu QS, Zhang BY
World neurosurgery. 2022
Abstract
BACKGROUND The role of tranexamic acid (TXA) in controlling blood loss during spine surgery remains unclear. With the publication of a new randomized-controlled trial (RCT), we conducted a meta-analysis to determine the safety and Efficacy of TXA in spine surgery. METHODS PubMed, Embase, Web of Science, and Cochrane databases were searched for relevant studies through 2022. Only randomized controlled trials were eligible for this study. The extracted data were analyzed using Revman 5.3 software for meta-analysis. RESULTS Twenty randomized controlled trials including 1497 patients undergoing spine surgery were included in this systematic evaluation. Compared with the control group, TXA significantly reduced total blood loss [mean difference (MD) - 218.96, 95% confidence interval（CI） - 309.77 to - 128.14, p < 0.00001], perioperative blood loss [MD - 90.54, 95%（CI） - 139.33 to - 41.75, p =0.0003], postoperative drainage [MD - 102.60, 95%（CI） - 139.51 to - 65.70, p < 0.00001]，reduced hospital stay [MD - 1.42, 95%（CI） - 2.71 to - 0.14, p=0.03], reduced total blood transfusion volume [MD - 551.06, 95%（CI） - 755.90 to - 346.22, p < 0.00001] and INR [MD -0.03, 95%（CI） -0.04 to-0.02, p < 0.00001]. CONCLUSION Based on the meta-analysis of 20 RCTs, we demonstrated that TXA reduces blood loss in open spine surgery, decreases transfusion rates, and shortens hospital stays. The TXA administration during the perioperative period does not increase the incidence of postoperative complications.
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The Effect of Topical Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Posterior Lumbar Laminectomy and Discectomy: A Randomized, Double-Blind, Controlled Trial Study
Farzanegan G, Ahmadpour F, Khoshmohabbat H, Khadivi M, Rasouli HR, Eslamian M
Asian spine journal. 2022
Abstract
STUDY DESIGN Randomized, double-blind, controlled trial study. PURPOSE This study aimed to evaluate the safety and efficacy of topical tranexamic acid (TXA) on intraoperative blood loss (IBL) in patients that have degenerative lumbar canal stenosis and undergo posterior lumbar laminectomy and discectomy. OVERVIEW OF LITERATURE The volume of IBL is directly proportional to potential surgical complications. Recent reports have shown that the topical use of antifibrinolytic drugs, such as TXA, during surgery might decrease IBL and improve patient outcomes. METHODS A total of 104 patients with lumbar canal stenosis were enrolled in this randomized, double blinded clinical trial. Participants were randomized and divided into two groups: TXA (54 cases) and control (50 cases). In the TXA group, a TXA solution was used for washing and soaking, whereas, in the control group, irrigation of wound was with normal saline. IBL, pre- and postoperative coagulative studies, operation time, conventional hemostatic agent usage, systemic complications, and length of hospitalization were consecutively recorded. All participants were followed for an additional two months to gather data on their recovery status and time to return to work (RTW). RESULTS At baseline, there was no difference in clinical or lab findings, between the groups. IBL and use of hemostatic agents were significantly decreased in TXA group, as compared to the control group (p=0.001 and p=0.011, respectively). Systemic complications, length of hospitalization, and RTW were not significantly different between groups (p=0.47, p=0.38, and p=0.08, respectively). CONCLUSIONS This study showed that topical use of TXA during surgery may decrease IBL and minimize the use of hemostatic materials during posterior midline-approach laminectomy and discectomy, without increasing the potential for complications seen with intravenous TXA usage.
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The Safety and Effectiveness of Tranexamic Acid in Lumbar Interbody Fusion Surgery: An Updated Meta-analysis of Randomized Controlled Trials
Lin GX, Chen CM, Zhu MT, Zheng L
World neurosurgery. 2022;166:198-211
Abstract
OBJECTIVE Several previous meta-analyses have been published, followed by additional randomized clinical trials investigating the effects of tranexamic acid (TXA) in patients undergoing posterior lumbar interbody fusion (PLIF) surgery. As a result, the purpose of this research is to present an updated quantitative analysis of the existing literature and to further explicate its effectiveness. METHODS PubMed, Embase, Web of Science, and Cochrane Library databases were searched for randomized controlled trials (RCTs) comparing the application of TXA and placebo in patients undergoing PLIF surgery from their establishment to December 31, 2021. Data on clinical outcomes, perioperative outcomes, and complications were collected. The summary statistics for continuous and dichotomous variables were derived as weighted mean difference (WMD) and relative risk (RR), respectively. RESULTS A total of 12 studies enrolling 1088 participants were included in this meta-analysis. The combined results revealed that TXA can decrease intraoperative blood loss (WMD: -84.83, P < 0.0001), total blood loss (WMD: -189.93, P < 0.00001), hidden blood loss (WMD: -134.69, P = 0.002), postoperative drainage (WMD: -100.71, P < 0.00001), postoperative hemoglobin loss (WMD: 6.21, P < 0.00001), operative time (WMD: -3.80, P = 0.007), hospital stay (WMD: -1.86, P = 0.001), and transfusion rates (RR: 0.41, P < 0.00001) in PLIF without increasing the risk of thromboembolic events (RR: 0.80, P = 0.43). CONCLUSIONS TXA can considerably decrease surgical blood loss, postoperative drainage, reduce operative times, hospital stays, and transfusion rates. Furthermore, the TXA group had lower postoperative hemoglobin drop values than the placebo group.
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Randomized, controlled trial of two tranexamic acid dosing protocols in adult spinal deformity surgery
Clohisy JCF, Lenke LG, Dafrawy MHE, Wolfe RC, Frazier E, Kelly MP
Spine deformity. 2022
Abstract
BACKGROUND Tranexamic acid (TXA) is an anti-fibrinolytic effective in reducing blood loss in orthopedic surgery. The appropriate dosing protocol for adult spinal deformity (ASD) surgery is not known. The purpose of this study was to evaluate two TXA protocols [low dose (L): 10 mg/kg bolus, 1 mg/kg/hr infusion; high dose (H): 50 mg/kg, 5 mg/kg/hr] in complex ASD surgery. METHODS Inclusion criteria were ASD reconstructions with minimum 10 fusion levels or planned 3-column osteotomy (3CO). Standard demographic and surgical data were collected. Intraoperative estimated blood loss (EBL) was calculated by suction canisters minus irrigation plus estimated blood lost in sponges, estimated to the nearest 50 mL. Serious adverse events (SAE) were defined a priori as: venothromboembolic event (VTE), cardiac arrhythmia, myocardial infarction, renal dysfunction, and seizure. All SAE were recorded. Simple t tests compared EBL between groups. Mean EBL by total blood volume (TBV), transfusion volume, complications related to TXA were secondary outcomes. RESULTS Sixty-two patients were enrolled and 52 patients completed the study; 25 were randomized to H and 27 to L. Demographic and surgical variables were not different between the two groups. EBL was not different between groups (H: 1596 ± 933 cc, L: 2046 ± 1105 cc, p = 0.12, 95% CI: - 1022 to 122 cc). EBL as a percentage of TBV was lower for the high-dose group (H: 29.5 ± 14.8%, L: 42.5 ± 26.2%, p = 0.03). Intraoperative transfusion volume (H: 961 ± 505 cc, L: 1105 ± 808 cc, p = 0.5) and post-operative transfusion volume (H: 513 ± 305 cc, L: 524 ± 245 cc, p = 0.9) were not different. SAE related to TXA were not different (p = 0.7) and occurred in 2 (8%) H and 3 (11%) L. There was one seizure (H), 2 VTE, and 2 arrhythmias. CONCLUSION No differences in EBL, transfusion volume, nor SAE were observed between H and L dose TXA protocols. High dose was associated with decreased TBV loss (13%). Further prospective study, with pharmacologic analysis, is required to determine appropriate TXA dosage in ASD surgeries. LEVEL OF EVIDENCE Therapeutic Level II. TRIAL REGISTRATION The study was registered at Clinicaltrials.gov (NCT02053363) February 3, 2014.
