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
Journal of neurosurgery. Pediatrics. 2022;:1-9
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.
Paediatric patients undergoing craniosynostosis surgery (n= 90).
Aprotinin (n= 30).
Tranexamic acid (TXA, n= 30). No intervention (n= 30).
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.
The Use of Tranexamic Acid for Elective Resection of Intracranial Neoplasms: A Systematic Review
World neurosurgery. 2022
BACKGROUND As an established antifibrinolytic agent, tranexamic acid (TXA) has garnered widespread use during surgery to limit intraoperative blood loss. Within the field of neurosurgery, it is often introduced in cases of traumatic brain injury or elective spine surgeries. However, its role during elective cranial surgeries is not well established. This study presents a systematic review of the use of TXA for elective surgical resection of intracranial neoplasms. METHODS We performed a systematic review using PRISMA guidelines to identify studies investigating the TXA use in elective neurosurgical resection of intracranial neoplasms. Variables extracted included patient demographics, surgical indications, type of surgery performed, TXA administration dose and route, operative duration, blood loss, transfusion rate, postoperative hemoglobin (Hb) levels, and complications. RESULTS After careful screening, 4 articles (consisting of 682 total patients) fit our inclusion/exclusion criteria. Two studies were prospective cohorts, one was a retrospective cohort, and one was a case series. Chi-squared testing of pooled data demonstrated that patients administered TXA had a significantly decreased need for blood transfusions during surgery (OR: 0.6273, 95% CI:0.4254-0.9251, p=0.018). Mean total blood loss was 821.9 mL in the TXA group and 1099.0 mL in the control group across studies. There was no significant difference in postoperative hemoglobin levels: means were 11.4 g/dL for both the TXA and control groups. CONCLUSION These results support the use of intraoperative TXA in tumor resection. However, its role in tumor resection has been less investigated when compared to the use of TXA in other areas of neurosurgery.
The Effect of Topical Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Posterior Lumbar Laminectomy and Discectomy: A Randomized, Double-Blind, Controlled Trial Study
Asian spine journal. 2022
STUDY DESIGN Randomized, double-blind, controlled trial study. PURPOSE This study aimed to evaluate the safety and efficacy of topical tranexamic acid (TXA) on intraoperative blood loss (IBL) in patients that have degenerative lumbar canal stenosis and undergo posterior lumbar laminectomy and discectomy. OVERVIEW OF LITERATURE The volume of IBL is directly proportional to potential surgical complications. Recent reports have shown that the topical use of antifibrinolytic drugs, such as TXA, during surgery might decrease IBL and improve patient outcomes. METHODS A total of 104 patients with lumbar canal stenosis were enrolled in this randomized, double blinded clinical trial. Participants were randomized and divided into two groups: TXA (54 cases) and control (50 cases). In the TXA group, a TXA solution was used for washing and soaking, whereas, in the control group, irrigation of wound was with normal saline. IBL, pre- and postoperative coagulative studies, operation time, conventional hemostatic agent usage, systemic complications, and length of hospitalization were consecutively recorded. All participants were followed for an additional two months to gather data on their recovery status and time to return to work (RTW). RESULTS At baseline, there was no difference in clinical or lab findings, between the groups. IBL and use of hemostatic agents were significantly decreased in TXA group, as compared to the control group (p=0.001 and p=0.011, respectively). Systemic complications, length of hospitalization, and RTW were not significantly different between groups (p=0.47, p=0.38, and p=0.08, respectively). CONCLUSIONS This study showed that topical use of TXA during surgery may decrease IBL and minimize the use of hemostatic materials during posterior midline-approach laminectomy and discectomy, without increasing the potential for complications seen with intravenous TXA usage.
Effect of tranexamic acid on blood loss, coagulation profile, and quality of surgical field in intracranial meningioma resection: A prospective randomized, double-blind, placebo-controlled study
Surgical neurology international. 2021;12:272
BACKGROUND Resection of intracranial meningioma has been associated with significant blood loss. Providing a clear surgical field and maintaining hemodynamic stability are the major goals of anesthesia during meningioma surgery. Tranexamic acid has been used to reduce blood loss in various neurosurgical settings with limited evidence in literature. A randomized, double-blind, and placebo-controlled trial was conducted to evaluate the efficacy of tranexamic acid on blood loss, coagulation profile, and quality of surgical field during resection of intracranial meningioma. METHODS Thirty patients aged 18-65 years undergoing elective meningioma resection surgery were given either tranexamic acid or placebo (0.9% saline), tranexamic acid at a loading dose of 20 mg/kg, and infusion of 1 mg/kg/h during surgery. The intraoperative blood loss, coagulation profile, and the surgical field using Likert scale were assessed. RESULTS The patients in tranexamic group had significantly decreased intraoperative blood loss compared to the placebo group (616.42 ± 393.42 ml vs. 1150.02 ± 416.1 ml) (P = 0.02). The quality of the surgical field was better in the tranexamic group (median score 4 vs. 2 on Likert Scale) (P < 0.001). Patients in tranexamic group had an improved coagulation profile and decreased blood transfusion requirement (p=0.016). The blood collected in closed suction drain in 24 h postsurgery was less in the tranexamic acid group compared to placebo group (84.7 ± 50.4 ml vs. 127.6 ± 62.2 ml) (P = 0.047). CONCLUSION Tranexamic acid bolus followed by infusion reduces perioperative blood loss by 46.43% and blood transfusion requirement with improved surgical field and coagulation profile in patients undergoing intracranial meningioma resection surgery.
Tranexamic acid given into wound reduces postoperative drainage, blood loss, and hospital stay in spinal surgeries: a meta-analysis
Journal of orthopaedic surgery and research. 2021;16(1):401
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.
Patients undergoing spinal surgery (13 studies).
Topical use of tranexamic acid (tTXA).
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).
Combined Use of Tranexamic Acid and Rivaroxaban in Posterior/Transforaminal Lumbar Interbody Fusion Surgeries Safely Reduces Blood Loss and Incidence of Thrombosis: Evidence From a Prospective, Randomized, Double-Blind, Placebo-Controlled Study
Global spine journal. 2021;:21925682211024556
STUDY DESIGN A prospective, randomized, double-blind, placebo-controlled study. OBJECTIVES There are few studies examining the balance between preventing venous thrombus embolism (VTE) and reducing blood loss in posterior/transforaminal lumbar interbody fusion (PLIF/TLIF) surgeries. This study aimed to evaluate the efficacy and safety of the combine application of TXA and rivaroxaban in patients undergoing PLIF/TLIF and explore relevant factors related to blood loss and VTE. METHODS Patients in group A which was the control group received 0.9% NaCl solution intravenously. Group B was treated by an intravenous injection of 2 g tranexamic acid (TXA) and the local use of 1 g intraoperatively. Group C was treated the same as group B intraoperatively, and they received 10 mg rivaroxaban qd treatment postoperatively. Eligible patients with an Autar score ≤ 10 were randomly assigned to group A or group B. Patients with an Autar score >10 were allocated into group C. RESULTS The intraoperative blood loss and postoperative drainage were lower in groups B and C than in group A (P < .001). The blood transfusion rate in group B was lower than that in group A (P < .001), while the incidence of VTE in group C was lower (P < .001). Four factors were found to be positively correlated with obvious total blood loss (P < .05). The data showed that 5 factors were correlated with the development of a thrombus (P < .1). CONCLUSIONS The combination of TXA and rivaroxaban in PLIF/TLIF patients is safe and effective in reducing D-dimer levels associated with VTE and reducing blood loss.
The Efficacy and Safety of Epsilon-Aminocaproic Acid for Perioperative Blood Management in Spinal Fusion Surgery: A systematic review and meta-analysis
World neurosurgery. 2021
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.
The Effect of Tranexamic Acid Administration on Early Endothelial Damage Following Posterior Lumbar Fusion Surgery
Journal of clinical medicine. 2021;10(7)
Tranexamic acid (TXA) protects against endothelial glycocalyx injury in vitro. We aimed to evaluate whether TXA could protect against endothelial glycocalyx degradation in patients undergoing posterior lumbar fusion surgery. Patients aged 30-80 years were enrolled. The TXA group was administered a loading dose of 10 mg/kg, followed by a 1 mg/kg/h infusion. Serum syndecan-1 and heparan sulfate concentrations, which are biomarkers of glycocalyx degradation, were measured at preoperative baseline (T0), immediately post-surgery (T1), and 2 h post-surgery (T2). Postoperative complications were assessed, including hypotension, desaturation, and acute kidney injury. Among the 121 patients who completed the study, 60 received TXA. There were no significant differences in the marker concentrations at each time point. However, the postoperative increase in syndecan-1 levels from baseline was significantly attenuated in the TXA group compared with the control group (median (interquartile range); T1 vs. T0: -1.6 (-5.3-2.6) vs. 2.2 (-0.7-4.8), p = 0.001; T2 vs. T0: 0.0 (-3.3-5.5) vs. 3.6 (-0.1-9.3), p = 0.013). Postoperative complications were significantly associated with the magnitude of the change in syndecan-1 levels (for T2 vs. T0: odds ratio: 1.08, 95% confidence interval: 1.02-1.14, p = 0.006). TXA administration was associated with reduced syndecan-1 shedding in patients undergoing posterior lumbar fusion surgery.
The administration of tranexamic acid for corrective surgery involving eight or more spinal levels: A systematic review and meta-analysis
Asian journal of surgery. 2021
As the number of fusion levels increases, the complexity of spinal correction surgery also increases. Thus, we conducted this study to determine the safety and efficacy of tranexamic acid (TXA) involving eight or more spinal fusion levels. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Assessing the Methodological Quality of Systematic Reviews (AMSTAR) guidelines, a search of the PubMed, Embase, CENTRAL, Web of Science, and ClinicalTrials.gov databases was conducted for relevant studies published prior to May 30, 2019. The primary outcomes, including blood loss and transfusion requirement, and the secondary outcomes, including general indices, postoperative hemoglobin, and coagulation function, were analyzed using Rev Man 5.3.5 software and STATA version 12.0. Eight randomized controlled trials (473 participants) were included in the study. Compared to the control treatments, TXA reduced intraoperative blood loss, total blood loss, transfusion volume, and prothrombin time. There were no significant differences between the TXA and non-TXA groups in transfusion rate, operative time, hospital stay, complications, hemoglobin level, and other coagulation function parameters. In the pediatric subgroup analysis, TXA additionally improved hemoglobin levels, platelet count, and prothrombin time international normalized ratio. The present meta-analysis showed that TXA reduced blood loss and transfusion volume in both adults and children. In pediatric patients, TXA led to a greater benefit in postoperative hemoglobin levels and coagulation function. Intravenous TXA is safe and effective in children with eight or more spinal corrective levels.
Intraoperative tranexamic acid use in patients undergoing excision of intracranial meningioma: Randomized, placebo-controlled trial
Surgical neurology international. 2021;12:289
BACKGROUND Intracranial meningioma resection is associated with substantial intraoperative bleeding. Intraoperative tranexamic acid (TXA) use can reduce bleeding in a variety of surgical procedures. The objective of this study was to evaluate the effects of TXA treatment on blood loss and transfusion requirements in patient undergoing resection of intracranial meningioma. METHODS We conducted a prospective, randomized double-blind clinical study. The patient scheduled to undergo excision of intracranial meningioma were randomly assigned to receive intraoperatively either intravenous TXA or placebo. Patients in the TXA group received intravenous bolus of 20 mg/kg over 20 min followed by an infusion of 1 mg/kg/h up to surgical wound closure. Efficacy was evaluated based on total blood loss and transfusion requirements. Postoperatively, thrombotic complications, convulsive seizure, and hematoma formation were noted. RESULTS Ninety-one patients were enrolled and randomized: 45 received TXA (TXA group) and 46 received placebo (group placebo). Total blood loss was significantly decreased in TXA group compared to placebo (283 ml vs. 576 ml; P < 0.001). Transfusion requirements were comparable in the two groups (P = 0.95). The incidence of thrombotic complications, convulsive seizure, and hematoma formation was similar in the two groups. CONCLUSION TXA significantly reduces intraoperative blood loss, but did not significantly reduced transfusion requirements in adults undergoing resection of intracranial meningioma.