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The Effect of Tranexamic Acid and Controlled Hypotension on Perioperative Blood Loss in Craniosynostosis Surgery
Moradi Farsani, D., Mazaheri, Z., Shafa, A.
Anesthesiology and pain medicine. 2023;13(1):e130462
Abstract
BACKGROUND Open cranial vault reconstruction is the standard technique of craniosynostosis correction that may cause significant blood loss. OBJECTIVES The current study aimed at comparing the effect of tranexamic acid (TXA), controlled hypotension, and their combination on perioperative blood loss and transfusion requirement in craniosynostosis surgery. METHODS The present randomized, double-blind clinical trial was conducted on 75 infants referred for craniosynostosis surgery during 2017 - 2018. Ten minutes before the start of surgery, 10 mg/kg of TXA was administered intravenously to patients in the first group (TXA group). In the second group, patients were subjected to the controlled hypotension anesthesia (CHA) using intravenous remifentanil 0.1 μ/kg (CHA group). In the third group, the patients underwent CHA similar to that of the second group, along with intravenous injection of 10 mg/kg of TXA (CHA-TXA group). Then, patients' mean arterial pressure (MAP), heart rate (HR), total blood loss, and transfusion volume were evaluated and recorded. RESULTS The results of the present study revealed that although the changes in MAP and HR parameters over time (three hours after surgery) were significant in all three groups, the lowest decrease was observed in the CHA-TXA group (P-value < 0.05). In addition, the total perioperative blood loss in the CHA-TXA group with the mean of 181.20 ± 82.71 cc was significantly less than the total perioperative blood loss in the CHA and TXA groups with the means of 262.00 ± 104.04 cc and 212.80 ± 80.75 cc, respectively (P-value < 0.05). Moreover, the transfusion volume in the CHA-TXA group with the mean of 112.40 ± 53.50 cc was significantly lower than the transfusion volume in the CHA and TXA groups with the means of 174.00 ± 73.93 cc and 160.63 ± 59.35 cc, respectively (P-value < 0.05). In contrast, the total blood loss and transfusion volume were not significantly different between the CHA and TXA groups (P-value > 0.05). CONCLUSIONS According to the results of the present study, although the administration of TXA alone could effectively prevent blood loss and was associated with fewer transfusion requirements, the combination of this approach with hypotensive anesthesia resulted in more reduction in perioperative blood loss and transfusion volume as well as better hemodynamic stability.
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Tranexamic acid in pediatric hemorrhagic trauma
Borgman, M. A., Nishijima, D. K.
The Journal of Trauma and Acute Care Surgery. 2023;94(1S Suppl 1):S36-s40
Abstract
There is strong evidence in adult literature that tranexamic acid (TXA) given within 3 hours from injury is associated with improved outcomes. The evidence for TXA use in injured children is limited to retrospective studies and one prospective observational trial. Two studies in combat settings and one prospective civilian US study have found association with improved mortality. These studies indicate the need for a randomized controlled trial to evaluate the efficacy of TXA in injured children and to clarify appropriate timing, dose and patient selection. Additional research is also necessary to evaluate trauma-induced coagulopathy in children. Recent studies have identified three distinct fibrinolytic phenotypes following trauma (hyperfibrinolysis, physiologic fibrinolysis, and fibrinolytic shutdown), which can be identified with viscohemostatic assays. Whether viscohemostatic assays can appropriately identify children who may benefit or be harmed by TXA is also unknown.
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Tranexamic Acid in Hip Reconstructions in Children with Cerebral Palsy: A Double-Blind Randomized Controlled Clinical Trial
Zuccon, A., Rogério Cardozo Kanaji, P., Serafini Barcellos, D., Zabulon, S., de Oliveira Saraiva, A., Yoshi de Freitas, T. A.
Children (Basel, Switzerland). 2023;10(12)
Abstract
Surgical treatment is indicated for hip dislocation in patients with cerebral palsy (CP), but it requires care due to the state of nutrition and associated clinical comorbidities. The use of resources that minimize blood loss and the need for blood transfusions are essential to avoid complications. Tranexamic acid (TXA) has been highlighted for orthopedic surgeries to control intraoperative bleeding; however, there is a lack of large studies for its use in hip surgeries in patients with CP. This study aims to evaluate the efficacy and safety of tranexamic acid to reduce bleeding in pediatric patients with cerebral palsy undergoing surgical treatment for hip instability. A sample of 31 patients with CP who underwent surgical treatment for hip dislocation (hip adductor stretching, varization osteotomy of the proximal femur and acetabuloplasty using the Dega technique) was randomly divided into groups: control (n = 10) and TXA (n = 21). Preoperative and 24 h hemoglobin concentrations, the length of hospital stay (LHS), and intraoperative bleeding (IB) were analyzed. TXA significantly reduced the IB (p = 0.02). The variance in hemoglobin concentration was lower for the TXA group, but without statistical significance (p = 0.06). There was no difference in LHS. Also, no statistical difference was observed for the number of transfusions (p = 0.08). The findings provide evidence of the effectiveness of TXA in decreasing intraoperative bleeding and its safety for use in pediatric patients with cerebral palsy.
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Effect of tranexamic acid on intraoperative blood loss in pediatric osteotomies around the hip: Study protocol for a double-blind randomized placebo-controlled trial
van Kouswijk, H. W., Tolk, J. J., van Bommel, C. P., Reijman, M., Kempink, D. R., de Witte, P. B.
Journal of children's orthopaedics. 2023;17(5):404-410
Abstract
BACKGROUND Proximal femoral and/or pelvic osteotomies (PFPOs) can be indicated for a multitude of hip pathologies in (often asymptomatic) children, to prevent future hip problems. These procedures can result in significant blood loss. Tranexamic acid (TXA) is an antifibrinolytic agent routinely administered in adult trauma and joint reconstruction surgery to reduce blood loss. TXA is also registered for use in children and reported safe and beneficial for pediatric trauma, cardiac, and spinal surgery. However, for pediatric orthopedics, particularly for PFPOs, the available evidence is limited. Therefore, the current trial will investigate the potential reducing effect of preoperative TXA on intraoperative blood loss in pediatric PFPOs. METHODS In this single-center, double-blind, randomized placebo-controlled trial, we aim to include 180 participants aged from 1 to 18 years undergoing PFPOs for any indication at our institution. Participants will be randomized to receive either TXA or placebo (saline) during anesthetic induction. The primary outcome is intraoperative estimated blood loss (mL/kg), which is determined gravimetrically. Secondary outcomes include the percentage of patients with excessive blood loss (>20 mL/kg), procedure time and hospital stay, and postoperative hemoglobin level changes. DISCUSSION This will be the first prospective study investigating the effect of preoperative TXA on intraoperative blood loss in pediatric PFPOs. Its results will help to determine whether it would be advisable to adopt preoperative TXA as a standard medication to minimize blood loss and prevent complications in this vulnerable population. TRIAL REGISTRATION EudraCT: 2022-002384-30. Prospectively registered on September 26, 2022.
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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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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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Editor's Choice
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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Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): a pilot randomized trial
Nishijima DK, VanBuren JM, Linakis SW, Hewes HA, Myers SR, Bobinski M, Tran NK, Ghetti S, Adelson PD, Roberts I, et al
Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2022
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Editor's Choice
Abstract
BACKGROUND The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage; however, the drug has not been evaluated in a trial in injured children. We evaluated the feasibility of a large-scale trial evaluating the effects of TXA in children with severe hemorrhagic injuries. METHODS Severely injured children (0 up to 18(th) birthday) were randomized into a double-blind randomized trial of 1) TXA 15 mg/kg bolus dose, followed by 2 mg/kg/hr infusion over 8 hours, 2) TXA 30 mg/kg bolus dose, followed by 4 mg/kg/hr infusion over 8 hours, or 3) normal saline placebo bolus and infusion. The trial was conducted at 4 pediatric Level I trauma centers in the United States between June 2018 and March 2020. We enrolled patients under federal exception from informed consent (EFIC) procedures when parents were unable to provide informed consent. Feasibility outcomes included the rate of enrollment, adherence to intervention arms, and ability to measure the primary clinical outcome. Clinical outcomes included global functioning (primary), working memory, total amount of blood products transfused, intracranial hemorrhage progression, and adverse events. The target enrollment rate was at least 1.25 patients per site per month. RESULTS A total of 31 patients were randomized with a mean age of 10.7 years (standard deviation [SD] 5.0 years) and 22 (71%) patients were male. The mean time from injury to randomization was 2.4 hours (SD 0.6 hours). Sixteen (52%) patients had isolated brain injuries and 15 (48%) patients had isolated torso injuries. The enrollment rate using EFIC was 1.34 patients per site per month. All eligible enrolled patients received study intervention (9 patients TXA 15 mg/kg bolus dose, 10 patients TXA 30 mg/kg bolus dose, and 12 patients placebo) and had the primary outcome measured. No statistically significant differences in any of the clinical outcomes were identified. CONCLUSION Based on enrollment rate, protocol adherence, and measurement of the primary outcome in this pilot trial, we confirmed the feasibility of conducting a large-scale, randomized trial evaluating the efficacy of TXA in severely injured children with hemorrhagic brain and/or torso injuries using EFIC.
PICO Summary
Population
Severely injured children enrolled in the TIC-TOC trial across four centers in US (n= 31).
Intervention
15 mg/kg of tranexamic acid (TXA) dose, followed by 2 mg/kg/hr infusion (n= 9).
Comparison
30 mg/kg of TXA dose, followed by 4 mg/kg/hr infusion (n= 10). Saline placebo and infusion (n= 12).
Outcome
All patients had their primary outcome measured. Feasibility outcomes included the rate of enrollment, adherence to intervention arms, and ability to measure the primary clinical outcome. Clinical outcomes included global functioning (primary), working memory, total amount of blood products transfused, intracranial hemorrhage progression, and adverse events. The mean time from injury to randomization was 2.4 hours (SD 0.6 hours). Sixteen (52%) patients had isolated brain injuries and 15 (48%) patients had isolated torso injuries. No statistically significant differences in any of the clinical outcomes were identified.
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Effectiveness and Adverse Effects of Tranexamic Acid in Bleeding during Adenotonsillectomy: A Randomized, Controlled, Double-blind Clinical Trial
Fornazieri MA, Kubo HKL, de Farias LC, da Silva AMF, Garcia ECD, Santos Gald, Pinna FR, Voegels RL
International archives of otorhinolaryngology. 2021;25(4):e557-e562
Abstract
Introduction Intra and postoperative bleeding are the most frequent and feared complications in adenotonsillectomy (AT). Tranexamic acid (TXA), which is known for its antifibrinolytic effects, has a proven benefit in reducing bleeding in hemorrhagic trauma and cardiac surgery; however, the effectiveness and timing of its application in AT have not yet been established. Objectives We aimed to evaluate the efficacy of TXA in controlling bleeding during and after AT and assess its possible adverse effects in children. Methods The present randomized, controlled, double-blind clinical trial included 63 children aged 2 to 12 years. They were randomly assigned to receive either intravenous TXA (10 mg/kg) or placebo 10 minutes before surgery. The volume of intraoperative bleeding, presence of postoperative bleeding, and adverse effects during and 8 hours after the surgery were assessed. Results No difference in bleeding volume was noted between the 2 groups (mean, 122.7 ml in the TXA group versus 115.5 ml in the placebo group, p = 0.36). No intraoperative or postoperative adverse effects were noted because of TXA use. Furthermore, no primary or secondary postoperative bleeding was observed in any of the participants. Conclusion In our pediatric sample, TXA (10 mg/kg) administration before AT was safely used, without any adverse effects. It did not reduce the bleeding volume in children during this type of surgery. Future studies should assess the use of higher doses of TXA and its administration at other time points before or during surgery.
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Enrollment with and without Exception from Informed Consent in a Pilot Trial of Tranexamic Acid in Children with Hemorrhagic Injuries
Linakis SW, Kuppermann N, Stanley RM, Hewes H, Myers S, VanBuren JM, Charles Casper T, Bobinski M, Ghetti S, Schalick WO 3rd, et al
Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2021
Abstract
BACKGROUND Federal exception from informed consent (EFIC) procedures allow studies to enroll patients with time-sensitive, life-threatening conditions when written consent is not feasible. Our objective was to compare enrollment rates with and without EFIC in a trial of tranexamic acid (TXA) for children with hemorrhagic injuries. METHODS We conducted a four-center randomized controlled pilot and feasibility trial evaluating TXA in children with severe hemorrhagic brain and/or torso injuries. We initiated the trial enrolling patients without EFIC. After 3 months of enrollment, we met our a priori futility threshold and paused the trial to incorporate EFIC procedures and obtain regulatory approval. We then restarted the trial allowing EFIC if the guardian was unable to provide timely written consent. We used descriptive statistics to compare characteristics of eligible patients approached with and without EFIC procedures. We also calculated the time delay to restart the trial using EFIC. RESULTS We enrolled 1 of 15 (6.7%) eligible patients (0.17 per site per month) prior to using EFIC procedures. Of the 14 missed eligible patients, 7 (50%) were not enrolled because guardians were not present or were injured and unable to provide written consent. After obtaining approval for EFIC, we enrolled 30 of 48 (62.5%) eligible patients (1.34 per site per month). Of these 30 patients, 22 (73.3%) were enrolled with EFIC. Of the 22, no guardians refused written consent after randomization. There were no significant differences in the eligibility rate and patient characteristics enrolled with and without EFIC procedures. Across all sites, the mean delay to restart the trial using EFIC procedures was 12 months. CONCLUSIONS In a multicenter trial of severely injured children, the use of EFIC procedures greatly increased the enrollment rate and was well accepted by guardians. Initiating the trial without EFIC procedures led to a significant delay in enrollment.
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Selection of the optimal dosage of tranexamic acid to reduce blood loss during pediatric cleft palate surgery
Shafa A, Shetabi H, Adineh-Mehr L, Bahrami K
Tzu chi medical journal. 2021;33(2):181-187
Abstract
OBJECTIVE The aim of the present study was to evaluate and select the optimal dosage of tranexamic acid (TXA) to reduce blood loss during cleft palate surgery in children. MATERIALS AND METHODS This randomized double-blind clinical trial was performed on 80 children under 3 years of age that were candidates for cleft palate surgery. These children were divided into four groups as follows: the first, second, and third groups received 5, 7.5, and 10 mg/kg of TXA, respectively. Moreover, the fourth group was considered as the control group. Before induction of anesthesia and then every 15 min during the surgery, some parameters such as mean arterial pressure, heart rate, SpO(2), and ETCO(2) were recorded. Moreover, the amount of blood loss during the surgery, the level of surgeon's satisfaction, and incidence rate of complications were assessed and recorded. RESULTS The amount of blood loss during the surgery in TXA groups receiving dosages of 5, 7.5, and 10 mg/kg with the means of 63.75 ± 10.62, 61.25 ± 15.03, and 61.00 ± 14.29, respectively, was significantly lower than that of the control group with the mean of 92.25 ± 19.83 (P < 0.001). Moreover, no significant difference was found between the three groups receiving TXA dosages in terms of the amount of blood loss, the level of surgeon's satisfaction (P > 0.05). CONCLUSION According to the results of the present study, all three dosages of TXA had a significant role in reducing blood loss in cleft palate surgery. Given the potential for increased risk of side effects from the drug, it seems safe to use the minimal dosage of this drug to control and reduce blood loss during cleft palate surgery in children <3 years of age.