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Effect of tranexamic acid on markers of inflammation in children undergoing craniofacial surgery
Fenger-Eriksen C, Rasmussen M, Juul N, Krog J, Hvas AM
Acta anaesthesiologica Scandinavica. 2020
Abstract
BACKGROUND Tranexamic acid (TXA) reduces blood loss and transfusion requirements during craniosynostosis surgery in small children. Possible interaction from TXA on the inflammatory system is unknown. OBJECTIVE To evaluate the effect of TXA on a wide range of inflammatory markers in children receiving TXA in a randomized, blinded and placebo controlled study design. METHODS Thirty children undergoing craniosynostosis surgery with significant blood loss received TXA (bolus dose of 10 mg kg(-1) followed by 8 hours continuous infusion of 3 mg kg(-1) h(-1) ) or placebo in a randomized, double-blinded study design. Using a new proximity extension assays employing a panel of inflammatory biomarkers samples was used for analysis of blood samples obtained preoperatively, 4h and 24 h after operation. RESULTS Ninety-two inflammatory parameters were measured. TXA did not affect any of the measured parameters as compared with placebo. Among 34 of the 92 pro- and antiinflammatory parameters investigated changes were observed between preoperative, 4 h or 24 h respectively, reflecting immune activation during surgical stress. CONCLUSION TXA administration in a low-dose regimen including bolus followed by 8h infusion during craniosynostosis surgery did not change any of 92 inflammatory markers as compared with placebo.
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Effects of Tranexamic Acid Based on its Population Pharmacokinetics in Pediatric Patients Undergoing Distraction Osteogenesis for Craniosynostosis: Rotational Thromboelastometry (ROTEM(TM)) Analysis
Kim EJ, Kim YO, Shim KW, Ko BW, Lee JW, Koo BN
International Journal of Medical Sciences. 2018;15((8)):788-795.
Abstract
Background: Distraction osteogenesis for craniosynostosis is associated with significant hemorrhage. Additionally, patients usually require several transfusions. Tranexamic acid (TXA) is effective for reducing blood loss and the need for transfusions during surgeries. However, the significance of TXA infusion has not been thoroughly described yet. Methods: Forty-eight children undergoing distraction osteogenesis for craniosynostosis were administered intraoperative TXA infusion (loading dose of 10 mg/kg for 15 min, followed by continuous infusion at 5 mg/kg/h throughout surgery; n = 23) or normal saline (control, n = 25). Rotational thromboelastometry (ROTEM(TM)) was conducted to monitor changes in coagulation perioperatively. Results: Blood loss during surgery was significantly lower in the TXA-treated group than it was in the control group (81 vs. 116 mL/kg, P = 0.003). Furthermore, significantly fewer transfusions of red blood cells and fresh frozen plasma were required in the TXA group. In the control group, clotting time during the postoperative period was longer than it was during the preoperative period. Similarly, clot strength was weaker during the postoperative period. D-dimer levels dramatically increased in the control group compared with the TXA group after surgery. The duration of mechanical ventilation and the number of postoperative respiratory-related complications were significantly greater in the control group than they were in the TXA group. Conclusions: TXA infusion based on population pharmacokinetic analysis is effective in reducing blood loss and the need for transfusions during the surgical treatment of craniosynostosis. It can also prevent the increase in D-dimer levels without affecting systemic hemostasis.
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3.
Effectiveness of tranexamic acid for reducing intraoperative bleeding in palatoplasties: a randomized clinical trial
Arantes GC, Pereira RM, de Melo DB, Alonso N, Duarte MD
Journal of Cranio-Maxillo-Facial Surgery : Official Publication of the European Association for Cranio-Maxillo-Facial Surgery. 2017;45((5):):642-648
Abstract
BACKGROUND Few data are available regarding blood loss during cleft palate surgery. This study assessed the effect of using tranexamic acid in the reduction of intraoperative bleeding. METHODS A double-blind, randomized clinical trial compared intraoperative bleeding and the incidence of oronasal fistulas after palatoplasties in a control group that was given placebo and an intervention group that was given 10 mg/kg tranexamic acid followed by a continuous infusion of 1 mg/kg/h of the same until the end of surgery. Patients who underwent primary palatoplasty with no known or suspected coagulation disorders at our institution during the study period were included in the study. RESULTS 70 patients were allocated, 66 received the intervention. Blood loss was reduced by 11.9%, without statistical significance. The incidence of fistulas in the intervention and control groups was 12.9% and 18.75%, respectively. The reduction of 5.8% (CI 95%: 12%-23.8%) was not significant. CONCLUSIONS The reduction of intraoperative blood loss was lower than expected and not statistically significant; a larger sample is needed to confirm the observed reduction. The drug did not seem to have negative effects on flap viability.
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4.
Evaluation of the efficacy of tranexamic acid on the surgical field in primary cleft palate surgery on children : a prospective, randomized clinical study
Durga P, Raavula P, Gurajala I, Gunnam P, Veerabathula P, Reddy M, Upputuri O, Ramachandran G
Cleft Palate-Craniofacial Journal. 2015;52((5)):e183-7.
Abstract
OBJECTIVE To assess the effect of tranexamic acid on the quality of the surgical field. DESIGN Prospective, randomized, double-blind study. SETTING Institutional, tertiary referral hospital. PARTICIPANTS American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. INTERVENTIONS Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. MAIN OUTCOME MEASURES Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. RESULTS Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. CONCLUSION Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.
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Tranexamic acid reducing blood transfusion in children undergoing craniosynostosis surgery
Song G, Yang P, Zhu S, Luo E, Feng G, Hu J, Li J, Li Y
Journal of Craniofacial Surgery. 2013;24((1):):299-303.
Abstract
BACKGROUND Surgical correction of craniosynostosis in children is associated with substantial intraoperative bleeding. Intraoperatively administered tranexamic acid (TXA) can lessen blood loss during orthopedic and cardiovascular surgery, but its efficacy in craniosynostosis surgery is uncertain. Therefore, a meta-analysis performed with published comparative studies was to determine whether TXA could reduce packed red blood cells (or erythrocytes) (PRBCs) transfused and blood loss during pediatric craniosynostosis surgery. METHODS Two PubMed and EMBASE electronic databases were searched until June 2012. Eligible studies were restricted in comparative controlled trials. RESULTS Four studies in 3 articles with 138 patients were included. The results showed that intraoperative administration of TXA can significantly reduce transfusion of PRBCs (weighed mean difference [WMD] = -10.81, 95% confidence interval [CI] = -16.84 to -4.78, P < 0.00001). In the level of blood loss, the meta-analysis on 4 studies showed that the difference was statistically significant (WMD = -20.53, 95% CI = -32.26 to -8.80, P = 0.0006) between the TXA groups and the control groups. However, the subgroup analysis on randomized controlled trials showed that TXA did not significantly reduce blood loss during surgery compared with the placebo group (WMD = -30.79, 95% CIs = -71.72 to 10.14, P = 0.14). CONCLUSIONS Tranexamic acid can significantly reduce the transfusion of PRBCs in children undergoing craniosynostosis surgery. However, there is a controversy on the efficacy of TXA in reducing blood loss. Therefore, new randomized controlled trials to assess the effects of TXA in children with craniosynostosis surgery should be conducted. Journal Article.
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6.
Intraoperative tranexamic acid reduces blood transfusion in children undergoing craniosynostosis surgery: a randomized double-blind study
Dadure C, Sauter M, Bringuier S, Bigorre M, Raux O, Rochette A, Canaud N, Capdevila X
Anesthesiology. 2011;114((4):):856-61.
Abstract
BACKGROUND Surgical correction of craniosynostosis in children is associated with substantial intraoperative bleeding. Tranexamic acid (TXA) decreases intraoperative blood loss during cardiac or orthopedic surgery in children. We hypothesized that intraoperative TXA would reduce blood transfusion relative to placebo in patients pretreated with erythropoietin.METHODS Forty consecutive children, American Society of Anesthesiologists status 1 or 2, scheduled to undergo surgical correction of craniosynostosis were randomly assigned to receive either intravenous TXA or saline, 0.9%, intraoperatively. All children received preoperative erythropoietin (600 U/kg once a week for 3 weeks before surgery). Perioperative blood loss, number and volume of transfusions, percentage of children who underwent transfusion, and side effects were noted after surgery and at the end of the study. Surgeon satisfaction and cost of treatment were also recorded.RESULTS There was no significant difference between groups in demographic or surgical data. In the TXA group, the volume of packed erythrocytes transfused was significantly reduced by 85% (from 11 to 1.6 ml/kg) intraoperatively and by 57% (from 16.6 to 7.2 ml/kg) throughout the study period (P < 0.05). Compared with the placebo group, the percentage of children requiring blood transfusion was lower in the TXA group during surgery (9 [45%] of 20 vs. 2 [11%] of 19 children; P < 0.05) and during the whole study period (14 [70%] of 20 vs. 7 [37%] of 19; P < 0.05). Preoperative and postoperative hematologic parameters were comparable in both groups. There were no adverse events.CONCLUSION In children undergoing surgical correction of craniosynostosis and pretreated with erythropoietin, intraoperative TXA reduces the transfusion requirement.