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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 Use of Tranexamic Acid for Elective Resection of Intracranial Neoplasms: A Systematic Review
Brown NJ, Wilson B, Ong V, Gendreau JL, Yang CY, Himstead AS, Shahrestani S, Shlobin NA, Reardon T, Choi EH, et al
World neurosurgery. 2022
Abstract
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.
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Effects of esmolol continuous infusion on blood loss in patients undergoing posterior lumbar internal fixation surgery: A prospective randomized study
Moon YE, Joo MA, Joo J
The Journal of international medical research. 2022;50(3):3000605221078705
Abstract
OBJECTIVE To determine the intravenous (i.v.) dose of esmolol needed to attenuate blood loss in patients undergoing posterior lumbar internal fixation (PLIF) surgery. METHODS This study randomized patients to either the E5 or E10 group. Patients in the E5 group received a 0.25 mg/kg i.v. loading dose of esmolol before anaesthesia, followed by an infusion of 5 µg/kg/min throughout the operation. Patients in the E10 group received a 0.5 mg/kg i.v. loading dose of esmolol before anaesthesia, followed by an infusion of 10 µg/kg/min throughout the operation. RESULTS The study analysed 33 patients: 16 in the E5 group and 17 in the E10 group. The mean ± SD blood loss at the end of surgery was significantly greater in the E5 than E10 group (586.3 ± 160.1 versus 347.7 ± 138.0 ml, respectively). The total amount of patient-controlled analgesia (PCA) used was significantly higher in the E5 than E10 group at 8 (26.1 ± 12.0 versus 17.5 ± 8.3 ml, respectively), 24 (58.4 ± 21.3 versus 44.1 ± 16.2 ml, respectively) and 48 h after surgery (90.0 ± 22.5 versus 69.3 ± 22.1 ml, respectively). CONCLUSION A continuous infusion of 10 µg/kg/min of esmolol can safely reduce blood loss during PLIF surgery. It was also shown to reduce postoperative PCA consumption.
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3D-Slicer Software-Assisted Neuroendoscopic Surgery in the Treatment of Hypertensive Cerebral Hemorrhage
Liao R, Liu L, Song B, Wan X, Wang S, Xu J
Computational and mathematical methods in medicine. 2022;2022:7156598
Abstract
OBJECTIVE To explore the 3D-slicer software-assisted endoscopic treatment for patients with hypertensive cerebral hemorrhage. METHODS A total of 120 patients with hypertensive cerebral hemorrhage were selected and randomly divided into control group and 3D-slicer group with 60 cases each. Patients in the control group underwent traditional imaging positioning craniotomy, and patients in the 3D-slicer group underwent 3D-slicer followed by precision puncture treatment. In this paper, we evaluate the hematoma clearance rate, nerve function, ability of daily living, complication rate, and prognosis. RESULTS The 3D-slicer group is better than the control group in various indicators. Compared with the control group, the 3D-slicer group has lower complications, slightly higher hematoma clearance rate, and better recovery of nerve function and daily living ability before and after surgery. The incidence of poor prognosis is low. CONCLUSION The 3D-slicer software-assisted endoscopic treatment for patients with hypertensive intracerebral hemorrhage has a better hematoma clearance effect, which is beneficial to the patient's early recovery and reduces the damage to the brain nerve of the patient.
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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
Farzanegan G, Ahmadpour F, Khoshmohabbat H, Khadivi M, Rasouli HR, Eslamian M
Asian spine journal. 2022
Abstract
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.
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Intracranial Hemorrhage following Spinal Surgery: A Systematic Review of a Rare Complication
Al-Saadi T, Al-Kindi Y, Allawati M, Al-Saadi H
Surgery journal (New York, N.Y.). 2022;8(1):e98-e107
Abstract
Introduction Intracranial hemorrhage (ICH) is a potentially severe complication of spinal surgeries. The occurrence of such complications causes deterioration of the patient's clinical status and delayed discharge from the hospital. Although no specific etiological factors were identified for this complication, but multiple risk factors might play role in its development, they include the use of anticoagulants, presence of uncontrolled hypertension, and perioperative patient positioning. Aim A systematic review of the literature to investigate the prevalence of different types of intracranial hemorrhages in patients who underwent spinal surgeries. Methods A literature review was conducted using multiple research databases. Data were extracted using multiple variables that were formulated incongruent with the study aim and then further analyzed. Results A total of 79 studies were included in our analysis after applying the exclusion criteria and removing of repeated studies, 109 patients were identified where they were diagnosed with intracranial hemorrhage after spine surgery with a mean age of 54 years. The most common type of hemorrhage was cerebellar hemorrhage (56.0%) followed by SDH and intraparenchymal hemorrhage; 23.9 and 17.4%, respectively. The most common spine surgery was laminectomy (70.6%), followed by fixation and fusion (50.5%), excision of spinal lesions was done in 20.2% of the patient, and discectomy (14.7%). Conclusion The data in this study showed that out of 112 patients with ICH, cerebellar hemorrhage was the most common type. ICH post-spine surgery is a rare complication and the real etiologies behind this complication are still unknown, cerebrospinal fluid drain and durotomy were suggested.
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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
Ravi GK, Panda N, Ahluwalia J, Chauhan R, Singla N, Mahajan S
Surgical neurology international. 2021;12:272
Abstract
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.
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The rule of brain hematoma pressure gradient and its influence on hypertensive cerebral hemorrhage operation
Sun G, Fu T, Liu Z, Zhang Y, Chen X, Jin S, Chi F
Scientific reports. 2021;11(1):4599
Abstract
To comparatively study the size of and variation in the 'brain-haematoma' pressure gradient for different surgical methods for hypertensive intracerebral haemorrhage (HICH) and analyse the gradient's influence on surgical procedures and effects of the haemorrhage. Seventy-two patients with HICH treated from 1/2019 to 12/2019 were randomly divided into two groups, namely, the keyhole endoscopy and large trauma craniotomy groups, according to different operative methods. Intraoperative changes in intracranial pressure (ICP) were monitored to calculate intraoperative alterations in the 'brain-haematoma' pressure gradient. Intraoperative characteristics (operative time, bleeding volume, volume of blood transfusion, and haematoma clearance rate) and postoperative characteristics (oedema, postoperative activities of daily living (ADL) scores, mortality rate and rebleeding rate) were compared between the two groups. In the keyhole endoscopy group, ICP decreased slowly; the 'brain-haematoma' pressure gradient was large, averaging 251.1 ± 20.6 mmH(2)O, and slowly decreased. The mean operative time was 83.6 ± 4.3 min, the mean bleeding volume was 181.2 ± 13.6 ml, no blood transfusions were given, the average postoperative haematoma clearance rate was 95.6%, the rate of severe oedema was 10.9%, and the average postoperative ADL score was 85.2%. In the large trauma craniotomy group, ICP rapidly decreased after craniotomy. When the haematoma was removed, the 'brain-haematoma' pressure gradient was small, averaging 132.3 ± 10.5 mmH2O, and slowly decreased. The mean operative time was 232 ± 26.1 min, the mean bleeding volume was 412.6 ± 35.2 ml, the average volume of blood transfusion was 281.3 ± 13.6 ml, and the average postoperative haematoma clearance rate was 82.3%; moreover, the rate of severe oedema was 72.1%, and the average postoperative ADL score was 39.0%. These differences were statistically significant (P < 0.05). Neither the death rate (P > 0.05, 2.7% VS 2.8%) nor rebleeding rate (P > 0.05, 2.7% VS 2.8%) showed any obvious changes. The magnitude and variation in the 'brain-haematoma' pressure gradient for different surgical methods significantly influence surgical procedures and effects of HICH. During keyhole endoscopy surgery, this gradient was relatively large and slowly decreased; the haematoma was therefore easier to remove. Advantages of this approach include a high haematoma clearance rate, decreased bleeding volume, decreased operative time, reduced trauma, decreased postoperative brain oedema and improved postoperative recovery of neurological function.Chinese Clinical Trial Register: ChiCTR1900020655 registration in 12/01/02,019 registration in 28/02/02,020 Number: NCOMMS-20-08,091.
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Tranexamic acid given into wound reduces postoperative drainage, blood loss, and hospital stay in spinal surgeries: a meta-analysis
Hui S, Peng Y, Tao L, Wang S, Yang Y, Du Y, Zhang J, Zhuang Q
Journal of orthopaedic surgery and research. 2021;16(1):401
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Editor's Choice
Abstract
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.
PICO Summary
Population
Patients undergoing spinal surgery (13 studies).
Intervention
Topical use of tranexamic acid (tTXA).
Comparison
Placebo.
Outcome
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).
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Effects of controlled hypotension with restrictive transfusion on intraoperative blood loss and systemic oxygen metabolism in elderly patients who underwent lumbar fusion
Qiu X, Tan Z, Tang W, Ye H, Lu X
Trials. 2021;22(1):99
Abstract
BACKGROUND The effects of restrictive fluid therapy combined with controlled hypotension in the elderly on systemic oxygen metabolism and renal function are clinical concerns. The aim of this study was to evaluate blood loss, oxygen metabolism, and renal function in different levels of controlled hypotension induced by intravenous nitroglycerin, in combination with limited infusion, in elderly patients undergoing posterior lumbar fusion. METHODS A total of 40 patients, aged 60-75 with ASA grade II or III, who were planned for posterior lumbar fusion were randomly allocated into two groups: experimental group [target mean arterial pressure 65 mmHg (MAP 65) or control group (MAP 75)]. Indicators for blood loss, hemodynamic, systemic oxygen metabolism, and renal function evaluation index were recorded before operation (T0), 1 h after induced hypotension (T1), 2 h after hypotension (T2), and in recovery (T3). We compared changes in these parameters between groups to evaluate the combined effects of controlled hypotension with restrictive infusion. RESULTS CI, DO(2)I, and VO(2)I were lower in both groups at T1-T3 compared with T0 (p < 0.05). DO(2)I and VO(2)I in the MAP 65 group were lower than the MAP 75 group after operation. In both groups, SCysC increased at T1, T2, and T3 (p < 0.05) compared with T0. CONCLUSIONS Restrictive transfusion and control MAP at 65 mmHg can slightly change in renal function and reduce the risk of insufficient oxygen supply and importantly have no significant effect on blood loss and postoperative complications. TRIAL REGISTRATION ChiCTR-INR-16008153 . Registered on 25 March 2016.