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.
The efficacy and safety of tranexamic acid in lumbar surgery: A meta-analysis of randomized-controlled trials
Joint diseases and related surgery. 2022;33(1):57-85
OBJECTIVES This meta-analysis aims to assess tranexamic acid (TXA) effectiveness and safety in lumbar surgery. PATIENTS AND METHODS Renewals of randomized-controlled trials (RCTs) were conducted utilizing databases of medical literature such as PubMed, China Science and Technology Journal Database, Cochrane Library, China National Knowledge Infrastructure (CNKI), and EMBASE to compare principal and safety endpoints. The risk ratio (RR), standard mean difference (SMD), and 95% confidence intervals (CIs) were calculated. For the evaluation of the quality of the included studies, the Cochrane risk of bias criteria were utilized by two authors. RESULTS In total, 49 articles were enrolled that included 4,822 patients. Of the patients, 2,653 were administered TXA and 2,169 were in the control group. The findings indicated that TXA was capable of significantly lowering postoperative blood loss (PBL), transfusion rate, transfusion volume, total blood loss (TBL), intraoperative blood loss (IBL), and drainage compared to the control group. Besides, hemoglobin (Hb) and hematocrit (Hct) values were higher in the TXA group compared to the control group. As the safety endpoints, TXA significantly reduced D-dimer levels compared to the control group; however, both TXA and control groups had no significant variations in deep venous thrombosis (DVT). Subgroup analysis was administrated according to the administration method of TXA and the operation type and intravenous and topical TXA were combined in the meta-analysis. CONCLUSION This meta-analysis showed that TXA had the potential to significantly lower PBL, transfusion rate, transfusion volume, TBL, IBL, and drainage compared to the control group. Besides, Hb and Hct values were higher in the TXA group compared to the control group. Its hemostatic potential after lumbar spine surgery is trustworthy. It is still controversial in safety endpoints that TXA can significantly reduce D-dimer compared to the control group, without no significant variations in DVT in both the TXA and control groups.
Patients undergoing lumbar surgery (49 studies, n= 4,822).
Tranexamic acid (TXA), (n= 2,653).
Normal saline (n= 2,169).
TXA significantly lowered postoperative blood loss, transfusion rate, transfusion volume, total blood loss, intraoperative blood loss, and drainage compared to the control group. Haemoglobin and haematocrit values were higher in the TXA group compared to the control group. As the safety endpoints, TXA significantly reduced D-dimer levels compared to the control group; however, both TXA and control groups had no significant variations in deep venous thrombosis.
Impact of the Tranexamic Acid on Bleeding Amount of Surgical Patient With Degenerative Spinal Disease: A Randomized Blinded Study
Frontiers in surgery. 2021;8:655692
Objective: This study aims to explore the effectiveness and safety of tranexamic acid (TXA) in reducing the bleeding amount of surgical patients with degenerative spinal disease in the perioperative period. Methods: A total of 80 cases of patients, who underwent elective posterior lumbar interbody fusion surgeries under general anesthesia, were enrolled in this study. The age of these patients ranged within 41-69 years old, and the surgical vertebral body segments were ≥2. The ASA classification was Level I or Level II. These patients were divided into two groups using the random number table (n = 40): TXA group and control group (S group). In the TXA group, the skin was incised after the anesthesia induction, and 20 mg/kg of TXA was immediately injected into the vein. The injection continued at a rate of 10 mg·kg(-1)·h(-1) during the surgery, until the surgery was finished. In the S group, IV and pump injection with an equal amount of normal saline (NS) were performed. Then, the RBC, Hb, HCT, AST, ALT, BUN, Cr, PT, TT, APTT, FIB, and D-dimer were measured before the surgery and at 1 day after the surgery, and the SSFQ, intraoperative bleeding amount, homologous transfusion volume, urine volume, infusion quantity, surgical duration, drainage volume at 24 h after the surgery, total bleeding amount and adverse event occurrence at 1 week after the surgery were recorded. Results: The RBC, Hb and HCT at 1 day after the surgery were higher in TXA group than in the S group (average P < 0.05). Intraoperative bleeding, drainage volume at 24 h after surgery, and total blood loss were lower in the TXA group than in the S group (average P < 0.05). The SSFQ score and length of stay were lesser in the TXA group than in the S group (average P < 0.05). The differences in AST, ALT, BUN, Cr, PT, TT, APTT, FIB, and D-dimer at 1 day after the surgery for these two groups of patients had no statistical significance (average P > 0.05). Conclusion: TXA can reduce the bleeding amount of surgical patients with degenerative spinal disease in the perioperative period and decrease the length of stay, but does not increase the occurrence rate of adverse events, thereby promoting postoperative rehabilitation. Clinical Trial Registration: www.chictr.org.cn/index.aspx, identifier: ChiCTR2000033597.
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 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.
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.
Association of tranexamic acid with decreased blood loss in patients undergoing laminectomy and fusion with posterior instrumentation: a systematic review and meta-analysis
Journal of neurosurgery. Spine. 2021;:1-8
OBJECTIVE Tranexamic acid (TXA) is an antifibrinolytic agent associated with reduced blood loss and mortality in a wide range of procedures, including spine surgery, traumatic brain injury, and craniosynostosis. Despite this wide use, the safety and efficacy of TXA in spine surgery has been considered controversial due to a relative scarcity of literature and lack of statistical power in reported studies. However, if TXA can be shown to reduce blood loss in laminectomy with fusion and posterior instrumentation, more surgeons may include it in their armamentarium. The authors aimed to conduct an up-to-date systematic review and meta-analysis of the efficacy of TXA in reducing blood loss in laminectomy and fusion with posterior instrumentation. METHODS A systematic review and meta-analysis, abiding by PRISMA guidelines, was performed by searching the databases of PubMed, Web of Science, and Cochrane. These platforms were queried for all studies reporting the use of TXA in laminectomy and fusion with posterior instrumentation. Variables retrieved included patient demographics, surgical indications, involved spinal levels, type of laminectomy performed, TXA administration dose, TXA route of administration, operative duration, blood loss, blood transfusion rate, postoperative hemoglobin level, and perioperative complications. Heterogeneity across studies was evaluated using a chi-square test, Cochran's Q test, and I2 test performed with R statistical programming software. RESULTS A total of 7 articles were included in the qualitative study, while 6 articles featuring 411 patients underwent statistical analysis. The most common route of administration for TXA was intravenous with 15 mg/kg administered preoperatively. After the beginning of surgery, TXA administration patterns were varied among studies. Blood transfusions were increased in non-TXA cohorts compared to TXA cohorts. Patients administered TXA demonstrated a significant reduction in blood loss (mean difference -218.44 mL; 95% CI -379.34 to -57.53; p = 0.018). TXA administration was not associated with statistically significant reductions in operative durations. There were no adverse events reported in either the TXA or non-TXA patient cohorts. CONCLUSIONS TXA can significantly reduce perioperative blood loss in cervical, thoracic, and lumbar laminectomy and fusion procedures, while demonstrating a minimal complication profile.
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.