Randomized, controlled trial of two tranexamic acid dosing protocols in adult spinal deformity surgery
Spine deformity. 2022
BACKGROUND Tranexamic acid (TXA) is an anti-fibrinolytic effective in reducing blood loss in orthopedic surgery. The appropriate dosing protocol for adult spinal deformity (ASD) surgery is not known. The purpose of this study was to evaluate two TXA protocols [low dose (L): 10 mg/kg bolus, 1 mg/kg/hr infusion; high dose (H): 50 mg/kg, 5 mg/kg/hr] in complex ASD surgery. METHODS Inclusion criteria were ASD reconstructions with minimum 10 fusion levels or planned 3-column osteotomy (3CO). Standard demographic and surgical data were collected. Intraoperative estimated blood loss (EBL) was calculated by suction canisters minus irrigation plus estimated blood lost in sponges, estimated to the nearest 50 mL. Serious adverse events (SAE) were defined a priori as: venothromboembolic event (VTE), cardiac arrhythmia, myocardial infarction, renal dysfunction, and seizure. All SAE were recorded. Simple t tests compared EBL between groups. Mean EBL by total blood volume (TBV), transfusion volume, complications related to TXA were secondary outcomes. RESULTS Sixty-two patients were enrolled and 52 patients completed the study; 25 were randomized to H and 27 to L. Demographic and surgical variables were not different between the two groups. EBL was not different between groups (H: 1596 ± 933 cc, L: 2046 ± 1105 cc, p = 0.12, 95% CI: - 1022 to 122 cc). EBL as a percentage of TBV was lower for the high-dose group (H: 29.5 ± 14.8%, L: 42.5 ± 26.2%, p = 0.03). Intraoperative transfusion volume (H: 961 ± 505 cc, L: 1105 ± 808 cc, p = 0.5) and post-operative transfusion volume (H: 513 ± 305 cc, L: 524 ± 245 cc, p = 0.9) were not different. SAE related to TXA were not different (p = 0.7) and occurred in 2 (8%) H and 3 (11%) L. There was one seizure (H), 2 VTE, and 2 arrhythmias. CONCLUSION No differences in EBL, transfusion volume, nor SAE were observed between H and L dose TXA protocols. High dose was associated with decreased TBV loss (13%). Further prospective study, with pharmacologic analysis, is required to determine appropriate TXA dosage in ASD surgeries. LEVEL OF EVIDENCE Therapeutic Level II. TRIAL REGISTRATION The study was registered at Clinicaltrials.gov (NCT02053363) February 3, 2014.
Clinical efficacy and safety of neuroendoscopic surgery for severe thalamic hemorrhage with ventricle encroachment
Neurosurgical review. 2022
To summarize and analyze the clinical efficacy and safety of neuroendoscopic surgery (NES) in the treatment of patients for severe thalamic hemorrhage with ventricle encroachment (THVE). Eighty-three patients with severe THVE were treated in the Neurosurgery Department of Anqing Hospital Affiliated to Anhui Medical University from July 2019 to August 2021. Our study was approved by the ethics committee. The patients were randomly divided into NES group and extraventricular drainage (EVD) group. The hospital stay, Glasgow coma scale (GCS) scores on the 1st and 14th days postoperatively, the incidence of intracranial infections, and the clearance of postoperative hematomas were compared and analyzed between the two groups. The patients had follow-up evaluations 6 months postoperatively. The prognosis was evaluated based on the activity of daily living (ADL) score. A head CT or MRI was obtained to determine whether there was hydrocephalus, cerebral infarction, or other related complications. Eighty-three patients were randomly divided into 41 cases of NES group and 42 cases of EVD group. The length of postoperative hospital stay was 17.42 ± 1.53 days, the GCS scores were 6.56 ± 0.21, and 10.83 ± 0.36 on days 1 and 14, respectively; intracranial infections occurred in 3 patients (7.31%) and the hematoma clearance rate was 83.6 ± 5.18% in the NES group, all of which were significantly better than the EVD group (P < 0.05). After 6 months of follow-up, 28 patients (68.29%) had a good prognosis, 5 patients (12.19%) died, and 4 patients (9.75%) had hydrocephalus in the NES group. In the EVD group, the prognosis was good in 15 patients (35.71%), 12 patients (28.57%) died, and 17 patients (40.47%) had hydrocephalus. The prognosis, mortality rate, and incidence of hydrocephalus in the NES group were significantly better than the EVD group (P < 0.05). Compared to traditional EVD, NES for severe THVE had a higher hematoma clearance rate, and fewer intracranial infections and patients with hydrocephalus, which together improve the clinical prognosis and is thus recommended for clinical use.
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 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.
Effects of esmolol continuous infusion on blood loss in patients undergoing posterior lumbar internal fixation surgery: A prospective randomized study
The Journal of international medical research. 2022;50(3):3000605221078705
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.
Effect of Tranexamic Acid on Blood Loss and the Quality of Surgical Field in Transsphenoidal Pituitary Surgeries: Double-Blind Placebo-Controlled Randomized Control Trial
Neurology India. 2022;70(3):960-964
BACKGROUND AND AIMS Pituitary adenomas are common intracranial neoplasms and several cases require surgery, radiotherapy or radiosurgery. Transsphenoidal access to the pituitary gland is the commonest surgical approach. In microscopic or endoscopic approach to the pituitary, even modest bleeding can significantly worsen the surgical field for the neurosurgeon, lengthen intra-operative time and lead to potentially catastrophic complications. METHODS The investigators hypothesized that administration of tranexamic acid (TXA) would improve the quality of the surgical field and reduce bleeding during transsphenoidal surgery (TSS) of pituitary tumors. Fifty American Society of Anesthesiologists (ASA) physical-status 1 or 2 patients undergoing TSS were randomized into two groups: T and P. Patients in Group T received 25 mg/kg bolus of TXA followed by intraoperative infusion of 1 mg/kg/hour, while those in Group P received a matching saline infusion. The operating neurosurgeon, and the anesthesiologist, who managed the patient and collected data, were blinded to the test drug. Surgical field quality was assessed using the Boezaart scale. A single neurosurgeon performed all the surgeries to ensure consistency in estimating the quality of the surgical field. RESULTS The median Boezaart score (interquartile range) was 3 (1.0) in Group T and 3.0 (1.5) in Group P (P = 0.03). There was an absolute blood loss reduction of nearly 32% with TXA use. Blood loss in Group T was 334 ± 101 mL, compared to 495 ± 226 mL in Group P (P = 0.002). CONCLUSION The administration of TXA significantly improved the quality of surgical field and reduced blood loss in patients undergoing TSS.
3D-Slicer Software-Assisted Neuroendoscopic Surgery in the Treatment of Hypertensive Cerebral Hemorrhage
Computational and mathematical methods in medicine. 2022;2022:7156598
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.
Clinical Application of Microsurgery Using the Cerebellar Medulla Fissure Approach in Severe Ventricular Hemorrhage with Casting of the Fourth Ventricle and Its Influence on Neurological Recovery
Evidence-based complementary and alternative medicine : eCAM. 2021;2021:3699233
OBJECTIVE To investigate the clinical application of microsurgery using the cerebellar medulla fissure approach in severe ventricular hemorrhage with casting of the fourth ventricle and its effect on neurological recovery. METHODS A total of 80 patients with severe intraventricular hemorrhage accompanied by casting and dilation of the fourth ventricle who were admitted to the neurosurgery department between July 2019 and December 2020 were randomly divided into an observation group and a control group, with 40 patients in each group. The drainage tube extubation time and length of hospital stay of the two groups were compared. The 3-day hematoma clearance of the two groups was observed. Postoperative consciousness was evaluated by GCS, and the patients' recovery was evaluated by GOS at three months. The activities of daily living (ADL) scores of the two groups were compared to evaluate patients' postoperative self-care ability. The incidence of postoperative complications in the two groups was collected. Independent risk factors for poor prognosis were analyzed by logistics regression. RESULTS The postoperative hospitalization time and the drainage tube extubation time in the observation group were significantly lower than those in the control group. The ratio of hematoma clearance ≥90% in the observation group was significantly higher than that of the control group. Postoperative GCS scores and GOS scores in the observation group were significantly higher than those of the control group. The rate of postoperative complications in the observation group was significantly lower than that of the control group. The rate of good ADL grading in the observation group was significantly higher than that in the control group. Age and surgical method were independent risk factors for poor prognosis. CONCLUSION Microsurgery using the cerebellar medulla fissure approach can effectively improve the condition of severe ventricular hemorrhage with casting of the fourth ventricle and promote the recovery of patients' neurological function.
Effects of controlled hypotension with restrictive transfusion on intraoperative blood loss and systemic oxygen metabolism in elderly patients who underwent lumbar fusion
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.
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.