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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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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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The Efficacy and Safety of Epsilon-Aminocaproic Acid for Perioperative Blood Management in Spinal Fusion Surgery: A systematic review and meta-analysis
Li S, Xing F, Cen Y, Zhang Z
World neurosurgery. 2021
Abstract
BACKGROUND Perioperative blood loss is a major concern in spinal fusion surgery, which often requires blood transfusion. A large amount of perioperative blood loss might increase the risks of various perioperative complications. Recently, there has been a series of clinical studies focusing on the perioperative administration of epsilon-aminocaproic acid (EACA) in spinal fusion surgery. The aim of this review was to evaluate the efficacy and safety of EACA in spinal fusion surgery. METHODS We systematically searched electronic databases (MEDLINE, EMBASE, PubMed, and Cochrane Central Register of Controlled Trials) up to April 2021. The perioperative blood loss, blood transfusion and complication data were extracted and analysed by RevMan Manager 5.3. RESULTS Finally, six randomized controlled studies, involving 398 patients undergoing spinal fusion surgery, were enrolled in this systematic review. Compared with the blank control group, the EACA group had significantly lower total perioperative blood loss, postoperative blood loss, postoperative hemoglobin, postoperative blood transfusion units, total blood transfusion units, and postoperative red blood cell transfusion units. Additionally, no significant differences were observed between the EACA group and control group in intraoperative blood loss, intraoperative blood transfusion units, intraoperative crystalloid administered, hospital stays, operative time, perioperative respiratory complications, and wound bleeding. CONCLUSIONS EACA in patients undergoing spinal fusion surgery is effective in perioperative hemostasis without increasing the incidence of postoperative complications. However, the long-term adverse side of EACA in spinal fusion surgery still need more large-scale trials.
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Timing of temporizing neurosurgical treatment in relation to shunting and neurodevelopmental outcomes in post-hemorrhagic ventricular dilatation of prematurity: a meta-analysis
Lai GY, Chu-Kwan W, Westcott AB, Kulkarni AV, Drake JM, Lam S
The Journal of pediatrics. 2021
Abstract
OBJECTIVE To determine the relationship between timing of initiation of temporizing neurosurgical treatment and rates of ventriculoperitoneal shunting (VPS) and neurodevelopmental impairment in premature infants with post-hemorrhagic ventricular dilatation (PHVD). STUDY DESIGN We searched MEDLINE, EMBASE, CINAHL, Web of Science, Cochrane Database of Systematic Reviews, and Cochrane Center Register of Controlled Trials for studies that reported on premature infants with PHVD who received TNP. Timing of TNP, gestational age, birth weight, and outcomes of conversion to VPS, moderate-to-severe NDI, infection, TNP revision, and death at discharge were extracted. RESULTS Sixty-two full-length articles and six conference abstracts (n=2533 patients) published through November 2020 were included. Pooled rate for conversion to VPS was 60.5% (95% CI=54.9-65.8), moderate-severe NDI 34.8% (95% CI=27.4-42.9), infection 8.2% (95% CI=6.7-10.1), revision 14.6% (95% CI=10.4-20.1), and death 12.9% (95% CI=10.2-16.4). Average age at TNP was 24.2+/-11.3 days. On meta-regression, older age at TNP was a predictor of conversion to VPS (p<0.001) and NDI (p<0.01). Later year of publication predicted increased survival (p<0.01) and external ventricular drains were associated with more revisions (p=0.001). Tests for heterogeneity reached significance for all outcomes and qualitative review showed heterogeneity in study inclusion and diagnosis criteria for PHVD and initiation of TNP. CONCLUSIONS Later timing of TNP predicted higher rates of conversion to VPS and moderate-severe NDI. Outcomes were often reported relative to number of patients who received TNP and criteria for study inclusion and initiation of TNP varied across institutions. There is need for more comprehensive outcome reporting that includes all infants with PHVD regardless of treatment.
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Ultrasonic Bone Scalpel (USBS) Does Not Reduce Blood Loss During Posterior Spinal Fusion (PSF) in Patients with Adolescent Idiopathic Scoliosis (AIS): Randomized Clinical Trial
Garg S, Thomas J, Darland H, Kim E, Kittelson J, Erickson M, Carry P
Spine. 2021;46(13):845-851
Abstract
STUDY DESIGN Randomized Clinical Trial. OBJECTIVE The aim of this study was to compare the efficacy of USBS with standard-of-care surgical instruments during posterior spinal fusion (PSF) in patients with adolescent idiopathic scoliosis (AIS) by evaluating the difference in estimated blood loss per level fused (EBL/level). SUMMARY OF BACKGROUND DATA PSF surgery for AIS is often associated with high blood loss. Use of an ultrasonic bone scalpel (USBS) has been proposed to reduce blood loss during scoliosis surgery. METHODS This was a single-blinded (patient-blinded), randomized, controlled superiority trial. We randomized 66 patients with AIS undergoing PSF to the control group (osteotome) or the experimental group (USBS). The primary outcome was intraoperative EBL/level obtained from red blood cell salvage reports. One-year follow-up was available for 57 of 62 (92%) of patients. RESULTS EBL/level averaged 35 and 39 mL/level in the experimental and control groups, respectively [adjusted mean difference USBS - osteotome -8 mL/level, 95% CI: -16.4 to 0.3 mL/level, P = 0.0575]. There was no difference in curve correction [adjusted mean difference: -1.7%, 95% CI: -7.0 to 3.6%, P = 0.5321] or operative time [adjusted mean difference: -3.55 minutes, 95% CI: -22.45 to 15.46 min, P = 0.7089] between groups. Complications requiring change in routine postoperative care were noted in eight patients: two occurred in patients assigned to the experimental group and six occurred in patients assigned to the control group. CONCLUSION There was no clinically significant difference in total blood loss, EBL/level, or complications between the two groups. In contrast to reports from other centers, at our high-volume spine center, USBS did not lead to reduced blood loss during PSF for AIS. These results may not be generalizable to centers with longer baseline operative times or higher baseline average blood loss during PSF for AIS.Level of Evidence: 1.
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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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Effect of Tranexamic Acid on Coagulation and Fibrin Clot Properties in Children Undergoing Craniofacial Surgery
Fenger-Eriksen C, Lindholm AD, Krogh L, Hell T, Berger M, Hermann M, Fries D, Juul N, Rasmussen M, Hvas AM
Thrombosis and haemostasis. 2020
Abstract
OBJECTIVE Craniosynostosis surgery in small children is very often associated with a high blood loss. Tranexamic acid (TXA) reduces blood loss during this procedure, although the potential underlying coagulopathy in these children is not known in detail. Objective was to determine the nature of any coagulopathy found during and after craniosynostosis surgery and to characterize the effect of TXA on fibrin clot formation, clot strength, and fibrinolysis. MATERIALS AND METHODS Thirty children received either TXA (bolus dose of 10 mg/kg followed by 8 hours continuous infusion of 3 mg/kg/h) or placebo. Dynamic whole blood clot formation assessed by thromboelastometry, platelet count, dynamic thrombin generation/thrombin-antithrombin, clot lysis assay, and fibrinogen/factor XIII (FXIII) levels were measured. Additionally, clot structure was investigated by real-time live confocal microscopy and topical data analysis. RESULTS Increased ability of thrombin generation was observed together with a tendency toward shortened activated partial thromboplastin time and clotting time. Postoperative maximum clot firmness was higher among children receiving TXA. FXIII decreased significantly during surgery in both groups.Resistance toward tissue plasminogen activator-induced fibrinolysis was higher in children that received TXA, as evidenced by topical data analysis and by a significant longer lysis time. Fibrinogen levels were higher in the TXA group at 24 hours. CONCLUSION A significant coagulopathy mainly characterized by changes in clot stability and not parameters of thrombin generation was reported. Tranexamic acid improved clot strength and reduced fibrinolysis, thereby avoiding reduction in fibrinogen levels.
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Antifibrinolytic agents for paediatric scoliosis surgery: a systematic review and meta-analysis
Karimi S, Lu VM, Nambiar M, Phan K, Ambikaipalan A, Mobbs RJ
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. 2019
Abstract
STUDY DESIGN Systematic review and meta-analysis of randomised controlled trials. OBJECTIVE The purpose of this study is to perform a systematic review and meta-analysis of antifibrinolytic agents for paediatric spine surgery. BACKGROUND Bleeding is an important consideration in paediatric scoliosis surgery; blood loss leads directly to higher morbidity and mortality. Antifibrinolytics are an attractive non-invasive method of reducing bleeding as evidenced in arthroplasty, cardiac surgery and adult scoliosis surgery. METHODS A thorough database search of Medline, PubMed, EMBASE and Cochrane was performed according to PRISMA guidelines, and a systematic review was performed. RESULTS Five randomised controlled trials were identified in this meta-analysis, consisting of a total of 285 spine surgery patients with subgroups of tranexamic acid (n = 101), epsilon aminocaproic acid (n = 61) and control (n = 123). This meta-analysis found that antifibrinolytics lead to statistically significant reductions in peri-operative blood loss (MD - 379.16, 95% CI [- 579.76, - 178.57], p < 0.001), intra-operative blood loss (MD - 516.42, 95% CI [- 1055.58, 22.74], p < 0.001), reduced fresh frozen plasma requirements (MD - 307.77, 95% CI [- 369.66, - 245.88], p < 0.001) and reduced post-operative blood loss (MD - 185.95, 95% CI [- 336.04, - 35.87], p = 0.02). CONCLUSION This meta-analysis concludes that antifibrinolytics lead to statistically significant reductions in peri-operative blood loss, intra-operative blood loss, reduced fresh frozen plasma requirements and reduced post-operative blood loss with TXA. These slides can be retrieved under Electronic Supplementary Material.
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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.