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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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A randomized trial of the effects of platelet- rich plasma on postoperative complications after meningomyelocele sac repair
Arabacı, Ö, Akyol, M. E., Çelikkaleli, E., Sönmez, B., Çetin, E., Beger, B.
European review for medical and pharmacological sciences. 2023;27(12):5552-5558
Abstract
OBJECTIVE Meningomyelocele is a common congenital neural tube defect. To reduce complications, we need early surgery and a multidisciplinary approach. In this study, we administered platelet-rich plasma (PRP) to babies with meningomyelocele following corrective surgery to minimize cerebrospinal fluid (CSF) leakage and accelerate the healing of the immature pouch tissue. We compared these with a control group that did not receive PRP. PATIENTS AND METHODS Of the 40 babies who had surgery with the diagnosis of meningomyelocele, 20 patients received PRP after surgical repair, and 20 were followed up without PRP. In the PRP group, 10 of the 20 patients underwent primary defect repair, the other 10 underwent flap repair. In the group that did not receive PRP, primary closure was performed in 14 patients and flap closure in six. RESULTS In the PRP group, CSF leakage occurred in one (5%) patient, and none developed meningitis. Partial skin necrosis occurred in three (15%) patients and wound dehiscence in three (15%) patients. In the group that did not receive PRP, CSF leakage occurred in nine (45%) patients, meningitis in seven (35%), partial skin necrosis in 13 (65%), and wound dehiscence in seven (35%) patients. The rate of CSF leakage and skin necrosis in the PRP group was significantly (p<0.05) lower than that in the PRP group. Furthermore, wound closure and healing were also improved in the PRP group. CONCLUSIONS We have shown that PRP treatment of postoperative meningomyelocele infants facilitates healing and lowers the risk of CSF leakage, meningitis, and skin necrosis.
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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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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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High-dose versus low-dose tranexamic acid for paediatric craniosynostosis surgery: a double-blind randomised controlled non-inferiority trial
Goobie SM, Staffa SJ, Meara JG, Proctor MR, Tumolo M, Cangemi G, Disma N
Br J Anaesth. 2020
Abstract
BACKGROUND Tranexamic acid (TXA) reduces blood loss and transfusion in paediatric craniosynostosis surgery. The hypothesis is that low-dose TXA, determined by pharmacokinetic modelling, is non-inferior to high-dose TXA in decreasing blood loss and transfusion in children. METHODS Children undergoing craniosynostosis surgery were enrolled in a two-centre, prospective, double-blind, randomised, non-inferiority controlled trial to receive high TXA (50 mg kg(-1) followed by 5 mg kg(-1) h(-1)) or low TXA (10 mg kg(-1) followed by 5 mg kg(-1) h(-1)). Primary outcome was blood loss. Low dose was determined to be non-inferior to high dose if the 95% confidence interval (CI) for the mean difference in blood loss was above the non-inferiority margin of -20 ml kg(-1). Secondary outcomes were transfusion, TXA plasma concentrations, and biological markers of fibrinolysis and inflammation. RESULTS Sixty-eight children were included. Values were non-inferior regarding blood loss (39.4 [4.4] vs 40.3 [6.2] ml kg(-1) [difference=0.9; 95% CI: -14.2, 15.9]) and blood transfusion (21.3 [1.6] vs 23.6 [1.5] ml kg(-1) [difference=2.3; 95% CI: -2.1, 6.7]) between high-dose (n=32) and low-dose (n=34) groups, respectively. The TXA plasma concentrations during surgery averaged 50.2 (8.0) and 29.6 (7.6) mug ml(-1). There was no difference in fibrinolytic and inflammatory biological marker concentrations. No adverse events were observed. CONCLUSIONS Tranexamic acid 10 mg kg(-1) followed by 5 mg kg(-1) h(-1) is not less effective than a higher dose of 50 mg kg(-1) and 5 mg kg(-1) h(-1) in reducing blood loss and transfusion in paediatric craniosynostosis surgery. CLINICAL TRIAL REGISTRATION NCT02188576.
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Reduced perioperative blood loss in children undergoing craniosynostosis surgery using prolonged tranexamic acid infusion: a randomised trial
Fenger-Eriksen C, D'Amore Lindholm A, Norholt SE, von Oettingen G, Tarpgaard M, Krogh L, Juul N, Hvas AM, Rasmussen M
British journal of anaesthesia. 2019
Abstract
BACKGROUND Tranexamic acid (TXA) reduces intraoperative blood loss and transfusion during paediatric craniosynostosis surgery. Additional reduction of postoperative blood loss may further reduce exposure to allogeneic blood products. We studied the effect of combined intra- and postoperative TXA treatment on postoperative blood loss in children. METHODS Thirty children admitted for craniosynostosis surgery were randomised to combined intra- and postoperative TXA treatment or placebo. The primary endpoint was postoperative blood loss. Secondary endpoints included total blood loss, transfusion requirements, and clot stability evaluated by tissue plasminogen activator-stimulated clot lysis assay. RESULTS TXA reduced postoperative blood loss by 18 ml kg(-1) (95% confidence interval 8.9) and total blood loss from a mean of (standard deviation [SD]; 20) ml kg(-1) to 28 (14) ml kg(-1) (P<0.001). Intraoperative red blood cell (RBC) and fresh frozen plasma (FFP) transfusions were reduced in the treatment group from RBC 14.0 (5.2) ml kg(-1) to 8.2 (5.1) ml kg(-1) (P=0.01) and from FFP 13.0 (6.3) ml kg(-1) to 7.8 (5.9) ml kg(-1) (P=0.03). Postoperative RBC transfusion median was 5 (inter-quartile range [IQR] 0-6) ml kg(-1) in the placebo group and 0 (0-5.7) ml kg(-1) in the TXA group. Resistance to lysis was higher in the treatment group (P<0.001). CONCLUSIONS Combined intra- and postoperative tranexamic acid treatment reduced postoperative and overall blood loss and transfusion requirements. Improved clot stability represents a possible mechanism for blood loss reduction.
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Longitudinal Changes in Disability Rating Scale Scores: A Secondary Analysis Among Patients With Severe TBI Enrolled in the Epo Clinical Trial
Benoit JS, Hannay HJ, Yamal JM, Francis DJ, Aisiku I, Robertson C
Journal of the International Neuropsychological Society : JINS. 2019;25(3):293-301
Abstract
OBJECTIVES Long-term neurological response to treatment after a severe traumatic brain injury (sTBI) is a dynamic process. Failure to capture individual heterogeneity in recovery may impact findings from single endpoint sTBI randomized controlled trials (RCT). The present study re-examined the efficacy of erythropoietin (Epo) and transfusion thresholds through longitudinal modeling of sTBI recovery as measured by the Disability Rating Scale (DRS). This study complements the report of primary outcomes in the Epo sTBI RCT, which failed to detect significant effects of acute treatment at 6 months post-injury. METHODS We implemented mixed effects models to characterize the recovery time-course and to examine treatment efficacy as a function of time post-injury and injury severity. RESULTS The inter-quartile range (25th-75th percentile) of DRS scores was 20-28 at week1; 8-24 at week 4; and 3-17 at 6 months. TBI severity group was found to significantly interact with Epo randomization group on mean DRS recovery curves. No significant differences in DRS recovery were found in transfusion threshold groups. CONCLUSIONS This study demonstrated the value of taking a comprehensive view of recovery from sTBI in the Epo RCT as a temporally dynamic process that is shaped by both treatment and injury severity, and highlights the importance of the timing of primary outcome measurement. Effects of Epo treatment varied as a function of injury severity and time. Future studies are warranted to understand the possible moderating influence of injury severity on treatment effects pertaining to sTBI recovery. (JINS, 2019, 25, 293-301).
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Antifibrinolytic agents for reducing blood loss in scoliosis surgery in children
McNicol ED, Tzortzopoulou A, Schumann R, Carr DB, Kalra A
The Cochrane Database of Systematic Reviews. 2016;((9)):CD006883.
Abstract
BACKGROUND This is an updated version of the original Cochrane review first published in 2008. Scoliosis surgery is often associated with substantial blood loss and potentially detrimental effects in children. Antifibrinolytic agents are often used to reduce perioperative blood loss. Clinical trials have evaluated their efficacy in children undergoing surgical correction of scoliosis, but no systematic review has been published. This review was first published in 2008 and was updated in 2016. OBJECTIVES To assess the efficacy and safety of aprotinin, tranexamic acid and aminocaproic acid in reducing blood loss and transfusion requirements in children undergoing surgery for correction of idiopathic or secondary scoliosis. SEARCH METHODS We ran the search for the previous review in June 2007. For this updated version, we searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 7), MEDLINE (1946 to August week 1 2015), Embase (1947 to 2015 week 38), Latin American Caribbean Health Sciences Literature (LILACS) (1982 to 14 August 2015), Database of Abstracts of Reviews of Effects (DARE; 2015, Issue 2) and reference lists of reviews and retrieved articles for randomized controlled trials in any language. We also checked the clinical trial registry at http://www.clinicaltrials.gov on 8 October 2015. SELECTION CRITERIA We included blinded and unblinded randomized controlled trials (RCTs) that evaluated the effects of antifibrinolytics on perioperative blood loss in children 18 years of age or younger and undergoing scoliosis surgery. DATA COLLECTION AND ANALYSIS Two review authors independently extracted data. The primary outcome was total blood loss (intraoperative and postoperative combined). Secondary efficacy outcomes were the number of participants receiving blood transfusion (both autologous and allogeneic) or receiving allogeneic blood transfusion alone, and the total amount of blood transfused. Safety outcomes included the number of deaths, the number of participants reporting any adverse event or a serious adverse event, withdrawals due to adverse events and the number of participants experiencing a specific adverse event (i.e. renal insufficiency, hypersensitivity or thrombosis). We assessed methodological risk of bias for each included study and employed the GRADE approach to assess the overall quality of the evidence. MAIN RESULTS We included three new studies (201 participants) in this updated review, for a total of nine studies (455 participants). All but one study employed placebo as the control group intervention. For the primary outcome, antifibrinolytic drugs decreased the amount of perioperative blood loss by 427 mL (95% confidence interval (CI) 251 to 603 mL), for a reduction of over 20% versus placebo. We rated the quality of evidence for our primary outcome as low on the basis of unclear risk of bias for several domains in most studies and the small total number of participants.For secondary outcomes, fewer participants receiving antifibrinolytic drugs received transfusion (allogeneic or autologous) versus those receiving placebo (risk ratio (RR) 0.65, 95% CI 0.50 to 0.85, number needed to treat to prevent one additional harmful outcome (NNTp) 5; very low-quality evidence). Only two studies specifically evaluated the number of participants transfused with only allogeneic blood (risk difference (RD) -0.15, 95% CI -0.26 to -0.03, NNTp 7; very low-quality evidence). Antifibrinolytic drugs decreased the volume of blood transfused by 327 mL (95% CI -186 to -469 mL; low-quality evidence).No study reported deaths in active or control groups. Data were insufficient to allow performance of meta-analysis for any safety outcome. No studies adequately described their methods in assessing safety. The only adverse event of note occurred in one study, when three participants in the placebo group developed postoperative deep vein thrombosis. AUTHORS' CONCLUSIONS Since the last published version of this review (2008), we have found three new studies. Additional evidence shows that
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Efficacy of tranexamic acid in pediatric craniosynostosis surgery: a double-blind, placebo-controlled trial
Goobie SM, Meier PM, Pereira LM, McGowan FX, Prescilla RP, Scharp LA, Rogers GF, Proctor MR, Meara JG, Soriano SG, et al
Anesthesiology. 2011;114((4):):862-71.
Abstract
BACKGROUND Extensive blood loss is common in pediatric craniosynostosis reconstruction surgery. Tranexamic acid (TXA) is increasingly used to reduce perioperative blood loss in various settings, but data on its efficacy are limited in children. The purpose of this randomized, double-blind, placebo-controlled, parallel trial was to evaluate the efficacy of TXA in pediatric craniosynostosis correction surgery. The primary and secondary outcome variables were reduction in perioperative blood loss and reduction in blood transfusion, respectively.METHODS Forty-three children, ages 2 months to 6 yr, received either placebo or TXA in a loading dose of 50 mg·kg(-1), followed by an infusion of 5 mg·kg·h(-1) during surgery. TXA plasma concentrations were measured.RESULTS The TXA group had significantly lower perioperative mean blood loss (65 vs. 119 ml·kg(-1), P < 0.001) and lower perioperative mean blood transfusion (33 vs. 56 ml· kg(-1), P = 0.006) compared to the placebo group. The mean difference between the TXA and placebo groups for total blood loss was 54 ml·kg(-1) (95% CI for the difference, 23-84 ml·kg(-1)) and for packed erythrocytes transfused was 23 ml·kg(-1) (95% CI for the difference, 7-39 ml·kg(-1)). TXA administration also significantly diminished (by two thirds) the perioperative exposure of patients to transfused blood (median, 1 unit vs. 3 units; P < 0.001). TXA plasma concentrations were maintained above the in vitro thresholds reported for inhibition of fibrinolysis (10 μg·ml(-1)) and plasmin-induced platelet activation (16 μg·ml(-1)) throughout the infusion.CONCLUSIONS TXA is effective in reducing perioperative blood loss and transfusion requirement in children undergoing craniosynostosis reconstruction surgery.
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Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery
Sethna NF, Zurakowski D, Brustowicz RM, Bacsik J, Sullivan LJ, Shapiro F
Anesthesiology. 2005;102((4):):727-32.
Abstract
BACKGROUND Excessive bleeding often occurs during pediatric scoliosis surgery and is attributed to numerous factors, including accelerated fibrinolysis. The authors hypothesized that administration of tranexamic acid would reduce bleeding and transfusion requirements during scoliosis surgery. METHODS Forty-four patients scheduled to undergo elective spinal fusion were randomly assigned to receive either 100 mg/kg tranexamic acid before incision followed by an infusion of 10 mg . kg . h during surgery (tranexamic acid group) or 0. 9% saline (placebo group). General anesthesia was administered according to a standard protocol. Blood loss, transfusion requirements, coagulation parameters, and complications were assessed. RESULTS In the tranexamic acid group, blood loss was reduced by 41% compared with placebo (1,230 +/- 535 vs. 2,085 +/- 1,188 ml; P < 0. 01). The amount of blood transfused did not differ between groups (615 +/- 460 vs. 940 +/- 718 ml; P = 0. 08). Administration of tranexamic acid was a multivariate predictor of blood loss, as was American Society of Anesthesiologists physical status and preoperative platelet count. No apparent adverse drug effects occurred in any patient. CONCLUSION Intraoperative administration of tranexamic acid significantly reduces blood loss during spinal surgery in children with scoliosis.