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Comparative efficacy and safety of different hemostatic medications during spinal surgery: A network meta-analysis
Tan H, Pan S, Wei C, Chen Z, Chen T
Medicine. 2023;102(9):e32923
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Abstract
BACKGROUND Significant blood loss is still one of the most frequent issues in spinal surgery. There were different hemostatic methods to prevent blood loss during spinal surgery. However, the optimal hemostatic therapy for spinal surgery is controversial. The purpose of this study was to assess the efficacy and safety of different hemostatic therapies in spinal surgery. METHODS Two independent reviewers conducted electronic literature searches in 3 electronic databases (PubMed, Embase, and Cochrane library database) as well as a manual search to identify eligible clinical studies from inception to Nov 2022. Studies that including different hemostatic therapy (tranexamic acid [TXA], epsilon-acetyl aminocaproic acid [EACA], and aprotinin [AP]) for spinal surgery were included. The Bayesian network meta-analysis was performed with a random effects model. The surface under the cumulative ranking curve (SUCRA) analysis was performed to determine the ranking order. All analyses were performed by R software and Stata software. P value less than .05 was identified as statistically significant. RESULTS Finally, a total of 34 randomized controlled trials met the inclusion criteria and finally included in this network meta-analysis. The SUCRA shows that TXA ranked first (SUCRA, 88.4%), AP ranked second (SUCRA, 71.6%), EACA ranked third (SUCRA, 39.9%), and placebo ranked the last (SUCRA, 0.3%) as for total blood loss. The SUCRA shows that TXA ranked first (SUCRA, 97.7%), AP ranked second (SUCRA, 55.8%), EACA ranked third (SUCRA, 46.2%), and placebo ranked the last (SUCRA, 0.2%) for need for transfusion. CONCLUSIONS TXA appears optimal in the reduction of perioperative bleeding and blood transfusion during spinal surgery. However, considering the limitations in this study, more large-scale, well-designed randomized controlled trials are needed to confirm these findings.
PICO Summary
Population
Patients undergoing spinal surgery (34 randomised controlled trials).
Intervention
Haemostatic therapy: tranexamic acid (TXA), epsilon-acetyl aminocaproic acid (EACA), and aprotinin (AP).
Comparison
Placebo.
Outcome
The Bayesian network meta-analysis was performed with a random effects model. The surface under the cumulative ranking curve (SUCRA) analysis was performed to determine the ranking order. For total blood loss, the SUCRA showed that TXA ranked first (SUCRA, 88.4%), AP ranked second (SUCRA, 71.6%), EACA ranked third (SUCRA, 39.9%), and placebo ranked the last (SUCRA, 0.3%). For need for transfusion, the SUCRA showed that TXA ranked first (SUCRA, 97.7%), AP ranked second (SUCRA, 55.8%), EACA ranked third (SUCRA, 46.2%), and placebo ranked the last (SUCRA, 0.2%).
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The efficacy and safety of tranexamic acid in lumbar surgery: A meta-analysis of randomized-controlled trials
Xiao K, Zhuo X, Peng X, Wu Z, Li B
Joint diseases and related surgery. 2022;33(1):57-85
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Abstract
OBJECTIVES This meta-analysis aims to assess tranexamic acid (TXA) effectiveness and safety in lumbar surgery. PATIENTS AND METHODS Renewals of randomized-controlled trials (RCTs) were conducted utilizing databases of medical literature such as PubMed, China Science and Technology Journal Database, Cochrane Library, China National Knowledge Infrastructure (CNKI), and EMBASE to compare principal and safety endpoints. The risk ratio (RR), standard mean difference (SMD), and 95% confidence intervals (CIs) were calculated. For the evaluation of the quality of the included studies, the Cochrane risk of bias criteria were utilized by two authors. RESULTS In total, 49 articles were enrolled that included 4,822 patients. Of the patients, 2,653 were administered TXA and 2,169 were in the control group. The findings indicated that TXA was capable of significantly lowering postoperative blood loss (PBL), transfusion rate, transfusion volume, total blood loss (TBL), intraoperative blood loss (IBL), and drainage compared to the control group. Besides, hemoglobin (Hb) and hematocrit (Hct) values were higher in the TXA group compared to the control group. As the safety endpoints, TXA significantly reduced D-dimer levels compared to the control group; however, both TXA and control groups had no significant variations in deep venous thrombosis (DVT). Subgroup analysis was administrated according to the administration method of TXA and the operation type and intravenous and topical TXA were combined in the meta-analysis. CONCLUSION This meta-analysis showed that TXA had the potential to significantly lower PBL, transfusion rate, transfusion volume, TBL, IBL, and drainage compared to the control group. Besides, Hb and Hct values were higher in the TXA group compared to the control group. Its hemostatic potential after lumbar spine surgery is trustworthy. It is still controversial in safety endpoints that TXA can significantly reduce D-dimer compared to the control group, without no significant variations in DVT in both the TXA and control groups.
PICO Summary
Population
Patients undergoing lumbar surgery (49 studies, n= 4,822).
Intervention
Tranexamic acid (TXA), (n= 2,653).
Comparison
Normal saline (n= 2,169).
Outcome
TXA significantly lowered postoperative blood loss, transfusion rate, transfusion volume, total blood loss, intraoperative blood loss, and drainage compared to the control group. Haemoglobin and haematocrit values were higher in the TXA group compared to the control group. As the safety endpoints, TXA significantly reduced D-dimer levels compared to the control group; however, both TXA and control groups had no significant variations in deep venous thrombosis.
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Antifibrinolytics use during surgery for oncological spine diseases: A systematic review
Avila MJ, Orenday-Barraza JM, Cavagnaro MJ, Strouse IM, Farhadi DS, Khan N, Hussein A, Baaj AA
Surgical neurology international. 2022;13:567
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Abstract
BACKGROUND Data exist of the benefits of antifibrinolytics such as tranexamic acid (TXA) in general spine surgery. However, there are limited data of its use in oncological spine patients. METHODS A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. PubMed, Cochrane, OVID, and Embase databases were searched. Search terms: "tranexamic acid", "aprotinin," "aminocaproic acid," "spine surgery," "spine tumors," and "spine oncology." Included studies were full text publications written in English with patients treated with either agent or who had surgery for oncological spine disease (OSD). RESULTS Seven hundred results were reviewed form the different databases, seven were selected. A total of 408 patients underwent spine surgery for OSD and received antifibrinolytics. There was a male predominance (55.2%) and mean age ranged from 43 to 62 years. The most common tumor operated was metastatic renal cancer, followed by breast and lung. Most studies administered TXA as a bolus followed by an infusion during surgery. Median blood loss was of 667 mL (253.3-1480 mL). Patients with TXA required 1-2 units less of transfusion and had 56-63 mL less of postoperative drainage versus no TXA. The median incidence of deep venous thrombosis (DVT) was 2.95% (0-7.9%) and for pulmonary embolism (PE) was 4.25% (0-14.3%). The use of TXA reduced intraoperative blood loss, transfusions and reduced postoperative surgical drainage output compared to no TXA use in patients with OSD. CONCLUSION In this review, we found that TXA may diminish intraoperative blood loss, the need for transfusion and postoperative drainage from surgical drains when used in OSD without major increase in rates of DVT or PE.
PICO Summary
Population
Patients undergoing spine surgery for oncological spine diseases (7 studies, n= 408).
Intervention
Perioperative antifibrinolytics (tranexamic acid (TXA), aprotinin, aminocaproic acid).
Comparison
No antifibrinolytics.
Outcome
The most common tumor operated was metastatic renal cancer, followed by breast and lung. Most studies administered TXA as a bolus followed by an infusion during surgery. Median blood loss was of 667 mL (253.3-1480 mL). Patients with TXA required 1-2 units less of transfusion and had 56-63 mL less of postoperative drainage vs. no TXA. The median incidence of deep venous thrombosis was 2.95% (0-7.9%) and for pulmonary embolism was 4.25% (0-14.3%). The use of TXA reduced intraoperative blood loss, transfusions and reduced postoperative surgical drainage output compared to no TXA use.
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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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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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Is fresh, leucodepleted, whole blood transfusion superior to blood component transfusion in pediatric patients undergoing spinal deformity surgeries? A prospective, randomized study analyzing postoperative serological parameters and clinical recovery
Vasan PK, Rajasekaran S, Viswanathan VK, Shetty AP, Kanna RM
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2021;:1-7
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Abstract
PURPOSE To compare the effectiveness of fresh whole blood (FWB) and blood component transfusion in improving clinical outcome and serological parameters in the early postoperative period following spinal deformity surgery. METHODS Patients undergoing major spinal deformity surgeries involving ≥ 6 levels of fusion and expected blood loss ≥ 750 ml between September 2017 and August 2018 were included in the study. The patients were randomized into two groups: FWBG and CG, receiving fresh whole blood and component transfusions, respectively. RESULTS A total of 65 patients with spinal deformities of different etiologies were included. The mean age was 14.0 and 14.9 years in FWB and CG, respectively. All other preoperative parameters were comparable. The mean fusion levels and surgical time were 11.1 and 221.20 min in FWB, as compared with 10.70 and 208.74minutes in CG, respectively. Intraoperative blood losses were 929 ml (FWBG) and 847 ml(CG), and the mean volumes of transfusion were 1.90 (FWBG) and 1.65 units (CG). FWBG was significantly superior to CG in the following clinical and laboratory parameters: duration of oxygen dependence [36.43 (FWBG) vs. 43.45 h (CG); P = 0.0256], mean arterial pH [7.442 (FWBG) vs. 7.394 (CG); p < 0.001], interleukin-6 [30.04 (FWBG) vs. 35.10 (CG); p < 0.019], mean duration of HDU stay [40.6 hours (FWBG) vs 46.51 hours (CG); p = 0.0234] and postoperative facial puffiness [7/30 in FWBG vs. 18/35 (CG) (P < 0.02)]. CONCLUSION FWB transfusion can potentially improve the immediate postoperative outcome in patients undergoing major spinal deformity surgeries by reducing the duration of intensive care unit stay and oxygen dependence. The other potential benefits of this practice, based on our study, include a reduced inflammatory response (reduced lactate and IL-6) and postoperative facial puffiness. However, further large-scale validation studies in future are necessary to precisely determine the role of FWB in spine surgeries. LEVEL OF EVIDENCE II Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.
PICO Summary
Population
Paediatric patients undergoing spinal deformity surgery (n= 65).
Intervention
Fresh whole blood: FWBG group (n= 30).
Comparison
Component transfusions: CG group (n = 35).
Outcome
The mean fusion levels and surgical time were 11.1 and 221.20 min in FWB, as compared with 10.70 and 208.74 minutes in CG, respectively. Intraoperative blood losses were 929 ml (FWBG) and 847 ml (CG), and the mean volumes of transfusion were 1.90 (FWBG) and 1.65 units (CG). FWBG was significantly superior to CG in the following clinical and laboratory parameters: duration of oxygen dependence, mean arterial pH, interleukin-6, mean duration of high dependency unit stay and postoperative facial puffiness.
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Tranexamic acid given into wound reduces postoperative drainage, blood loss, and hospital stay in spinal surgeries: a meta-analysis
Hui S, Peng Y, Tao L, Wang S, Yang Y, Du Y, Zhang J, Zhuang Q
Journal of orthopaedic surgery and research. 2021;16(1):401
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Abstract
BACKGROUND Although intravenous tranexamic acid administration (ivTXA) has prevailed in clinical antifibrinolytic treatment, whether it increases thromboembolic risks has remained controversial. As a potent alternative to ivTXA, topical use of TXA (tTXA) has been successfully applied to attenuate blood loss in various surgical fields while minimizing systemic exposure to TXA. This meta-analysis was conducted to gather scientific evidence for tTXA efficacy on reducing postoperative drainage, blood loss, and the length of hospital stay in spine surgeries. OBJECTIVES To examine whether topical use of TXA (tTXA) reduces postoperative drainage output and duration, hidden blood loss, hemoglobin level drop, hospital stay, and adverse event rate, we reviewed both randomized and non-randomized controlled trials that assessed the aforementioned efficacies of tTXA compared with placebo in patients undergoing cervical, thoracic, or lumbar spinal surgeries. METHODS An exhaustive literature search was conducted in MEDLINE and EMBASE databases from January 2000 through March 2020. Measurable outcomes were pooled using Review Manager (RevMan) version 5.0 in a meta-analysis. RESULTS Significantly reduced postoperative drainage output (weighted mean difference [WMD]= - 160.62 ml, 95% confidence interval (95% CI) [- 203.41, - 117.83]; p < .00001) and duration (WMD= - 0.75 days, 95% CI [- 1.09, - 0.40]; p < .0001), perioperative hidden blood loss (WMD= - 91.18ml, 95% CI [- 121.42, - 60.94]; p < .00001), and length of hospital stay (WMD= - 1.32 days, 95% CI [- 1.90, - 0.74]; p < .00001) were observed in tTXA group. Pooled effect for Hb level drop with tTXA vs placebo crossed the equivalent line by a mere 0.05 g/dL, with the predominant distribution of 95% confidence interval (CI) favoring tTXA use. CONCLUSIONS With the most comprehensive literature inclusion up to the present, this meta-analysis suggests that tTXA use in spinal surgeries significantly reduces postoperative drainage, hidden blood loss, and hospital stay duration. The pooled effect also suggests that tTXA appears more effective than placebo in preserving postoperative Hb level, which needs further validation by future studies.
PICO Summary
Population
Patients undergoing spinal surgery (13 studies).
Intervention
Topical use of tranexamic acid (tTXA).
Comparison
Placebo.
Outcome
Those in the tTXA group showed significantly reduced postoperative drainage output (weighted mean difference (WMD) = - 160.62 ml) and duration (WMD = - 0.75 days), perioperative hidden blood loss (WMD = - 91.18ml), and length of hospital stay (WMD = - 1.32 days).
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A systematic review and meta-analysis of traumatic intracranial hemorrhage in patients taking prehospital antiplatelet therapy: Is there a role for platelet transfusions?
Alvikas J, Myers SP, Wessel CB, Okonkwo DO, Joseph B, Pelaez C, Doberstein C, Guillotte AR, Rosengart MR, Neal MD
The journal of trauma and acute care surgery. 2020
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Abstract
BACKGROUND Platelet transfusion has been utilized to reverse platelet dysfunction in patients on pre-injury antiplatelets who have sustained a traumatic intracranial hemorrhage (tICH); however, there is little evidence to substantiate this practice. The objective of this study was to perform a systematic review on the impact of platelet transfusion on survival, hemorrhage progression and need for neurosurgical intervention in patients with tICH on prehospital antiplatelet medication. METHODS Controlled, observational and randomized, prospective and retrospective studies describing tICH, pre-injury antiplatelet use, and platelet transfusion reported in PubMed, Embase, Cochrane Reviews, Cochrane Trials and Cochrane DARE databases between January 1987 and March 2019 were included. Investigations of concomitant anticoagulant use were excluded. Risk of bias was assessed using the Newcastle-Ottawa scale. We calculated pooled estimates of relative effect of platelet transfusion on the risk of death, hemorrhage progression and need for neurosurgical intervention using the methods of Dersimonian-Laird random-effects meta-analysis. Sensitivity analysis established whether study size contributed to heterogeneity. Subgroup analyses determined whether antiplatelet type, additional blood products/reversal agents, or platelet function assays impacted effect size using meta-regression. RESULTS Twelve articles out of 18609 screened references were applicable to our PICOS questions were qualitatively and quantitatively analyzed. We found no association between platelet transfusion and the risk of death in patients with tICH taking prehospital antiplatelets (OR 1.29; 95% CI 0.76-2.18; p=0.346; I=32.5%). There was no significant reduction in hemorrhage progression (OR 0.88; 95% CI 0.34-2.28; p=0.788; I=78.1%). There was no significant reduction in the need for neurosurgical intervention (OR 1.00, 95% CI 0.53-1.90, p=0.996, I=59.1%, p=0.032). CONCLUSIONS Current evidence does not support the use of platelet transfusion in patients with tICH on prehospital antiplatelets highlighting the need for a prospective evaluation of this practice. LEVEL OF EVIDENCE level III, Systematic Reviews and Meta-Analyses.
PICO Summary
Population
Patients with traumatic intracranial hemorrhage (tICH) on prehospital antiplatelet medication, (12 studies).
Intervention
Platelet transfusion to reverse platelet dysfunction.
Comparison
Outcome
No association was found between platelet transfusion and the risk of death in patients with tICH taking prehospital antiplatelets (OR 1.29, I2= 32.5%). There was no significant reduction in hemorrhage progression (OR 0.88, I2= 78.1%). There was no significant reduction in the need for neurosurgical intervention (OR 1.00, I2= 59.1%).
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A randomised controlled trial of fibrinogen concentrate during scoliosis surgery
Chen W, Shen J, Zhang Y, Hu A, Liang J, Ma L, Yu X, Huang Y
Anaesthesia. 2020
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Abstract
Bleeding and blood transfusion are common after scoliosis surgery. Fibrinogen is essential for blood clot formation and depletes quickly during haemorrhage. We randomly allocated 102 children 12-18 years old having surgery for idiopathic scoliosis, 51 to intra-operative fibrinogen concentrate 30 mg.kg(-1) (maximum 2 g) and 51 to saline placebo. Fibrinogen reduced peri-operative blood loss by a median (95%CI) volume of 155 (5-320) ml, from a median (IQR [range]) of 1035 (818-1420 [400-3030]) ml to 885 (755-1155 [270-2645]) ml, p = 0.04. Seven and four children received allogeneic red blood cell transfusion after fibrinogen and placebo, respectively, p = 0.34. There were no side-effects.
PICO Summary
Population
Patients between 12 to 18 years old having surgery for idiopathic scoliosis (n= 102).
Intervention
Intraoperative fibrinogen concentrate (30 mg.kg−1, maximum 2 g), (n= 51).
Comparison
Saline placebo (n= 51).
Outcome
Fibrinogen concentrate infusion reduced median perioperative bleeding by about 155ml compared with placebo. Fibrinogen did not reduce postoperative blood transfusion or increase postoperative haemoglobin concentration.
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Comparison of Blood-Conserving and Allogenic Transfusion-Sparing Effects of Antifibrinolytics in Scoliosis Correction Surgery
Ramkiran S, Kumar M, Krishnakumar L, Nair SG
Anesthesia, essays and researches. 2020;14(2):259-265
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Abstract
BACKGROUND Intraoperative antifibrinolytic drug administration is a safe and effective method of reducing blood loss and allogenic transfusions in patients undergoing spine deformity correction. AIM: This study aimed to compare the effectiveness of two antifibrinolytic drugs tranexamic acid (TXA) and epsilon amino caproic acid (EACA) in reducing peri-operative blood loss and transfusion requirements against a placebo control in patients with idiopathic scoliosis undergoing correction surgery. SETTING AND DESIGN This is a prospective, randomized, double-blinded, controlled comparative study. METHODOLOGY Patients in TXA group received 50 mg.kg(-1) bolus and 10 mg.kg(-1).h(-1) infusion as against 100 mg.kg(-1) and 10 mg.kg(-1).h(-1) infusion in EACA group. The placebo group had saline bolus and infusion. Parameters observed included baseline demographic and deformity data, duration of surgery, total peri-operative blood loss, and allogenic packed red cell transfusion requirements. STATISTICAL ANALYSIS Mean and standard deviation were used to represent the quantitative continuous data, and percentage was used to represent categorical data. The Student's t-test and ANOVA were used to compare means between groups. Bonferroni's multiple comparison test was used to find out the association between categorical variables. RESULTS A total of 36 patients were enrolled with 12 patients in each group. Peri-operative blood loss was 50.1% lower in patients receiving TXA and 17.7% lower in patients receiving EACA compared with the placebo group. The volume of total packed red cell transfusion was 66.7% lower in patients receiving TXA and 45.6% lower in patients receiving EACA compared with placebo. CONCLUSION TXA was more effective in reducing total peri-operative blood loss and allogenic transfusion requirement in idiopathic scoliosis correction surgery compared to EACA.
PICO Summary
Population
Patients with idiopathic scoliosis undergoing correction surgery (n= 36).
Intervention
Tranexamic acid (TXA, n= 12).
Comparison
Epsilon amino caproic acid (EACA, n= 12). Placebo (saline, n= 12).
Outcome
Peri-operative blood loss was 50.1% lower in patients receiving TXA and 17.7% lower in patients receiving EACA compared with the placebo group. The volume of total packed red cell transfusion was 66.7% lower in patients receiving TXA and 45.6% lower in patients receiving EACA compared with placebo.