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1.
Leukocyte- and platelet-rich fibrin in cranial surgery: a single-blinded, prospective, randomized controlled noninferiority trial
Coucke, B., De Vleeschouwer, S., van Loon, J., Van Calenbergh, F., Van Hoylandt, A., Van Gerven, L., Theys, T.
Journal of neurosurgery. 2024;:1-9
Abstract
OBJECTIVE CSF leakage is a major complication after cranial surgery, and although fibrin sealants are widely used for reinforcing dural closure, concerns exist regarding their safety, efficacy, and cost. Leukocyte- and platelet-rich fibrin (L-PRF), an autologous platelet concentrate, is readily available and inexpensive, making it a cost-effective alternative for commercially available fibrin sealants. This study aimed to demonstrate the noninferiority of L-PRF compared with commercially available fibrin sealants in preventing postoperative CSF leakage in supra- and infratentorial cranial surgery, with secondary outcomes focused on CSF leakage risk factors and adverse events. METHODS In a single-blinded, prospective, randomized controlled interventional trial conducted at a neurosurgery department of a tertiary care center (UZ Leuven, Belgium), patients undergoing elective cranial neurosurgery were randomly assigned to receive either L-PRF (active treatment) or commercially available fibrin sealants (control) for dural closure in a 1:1 ratio. RESULTS Among 350 included patients, 328 were analyzed for the primary endpoint (44.5% male, mean age 52.3 ± 15.1 years). Six patients (5 in the control group, 1 in the L-PRF group) presented with CSF leakage requiring any intervention (relative risk [RR] 0.20, one-sided 95% CI -∞ to 1.02, p = 0.11), confirming noninferiority. Of these 6 patients, 1 (in the control group) presented with CSF leakage requiring revision surgery. No risk factors for reconstruction failure in combination with L-PRF were identified. RRs for adverse events such as infection (0.72, 95% CI -∞ to 1.96) and meningitis (0.36, 95% CI -∞ to 1.25) favored L-PRF treatment, although L-PRF treatment showed slightly more bleeding events (1.44, 95% CI -∞ to 4.66). CONCLUSIONS Dural reinforcement with L-PRF proved noninferior to commercially available fibrin sealants, with no safety issues. Introducing L-PRF to standard clinical practice could result in important cost savings due to accessibility and lower cost. Clinical trial registration no.: NCT03812120 (ClinicalTrials.gov).
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2.
The effect of perioperative sequential application of multiple doses of tranexamic acid on postoperative blood loss after PLIF: A prospective randomized controlled trial
Dong, W., Tang, Y., Lei, M., Ma, Z., Zhang, X., Shen, J., Hao, J., Jiang, W., Hu, Z.
International journal of surgery (London, England). 2024
Abstract
BACKGROUND Tranexamic acid (TXA) has been utilized in spinal surgery to effectively reduce intraoperative blood loss (IBL) and allogeneic blood transfusion rates. However, the traditional TXA regimen might last the entire duration of hyperfibrinolysis caused by surgical trauma, resulting in its limited ability to reduce postoperative blood loss (PBL). Therefore, the aim of this study was to investigate the effectiveness of perioperative sequential administration of multiple doses of TXA in reducing PBL in patients who underwent posterior lumbar interbody fusion (PLIF). METHODS From February 2022 to June 2023, 231 patients who were diagnosed with lumbar degenerative disease and scheduled to undergo PLIF were prospectively enrolled in the present study. The patients were randomly divided into three groups. Moreover, all patients received an intravenous injection of TXA at a dose of 15 mg/kg 15 min before surgical skin incision. Patients in Group A received a placebo of normal saline after surgery, while patients in Group B received three additional intravenous injections of TXA at a dose of 15 mg/kg every 24 h. Patients in Group C received three additional intravenous injections of TXA at a dose of 15 mg/kg every 5 h. The primary outcome measure was PBL. In addition, this study assessed total blood loss (TBL), IBL, routine blood parameters, liver and kidney function, coagulation parameters, fibrinolysis indexes, inflammatory indicators, drainage tube removal time (DRT), length of hospital stay (LOS), blood transfusion rate, and incidence of complications for all subjects. RESULTS The PBL, TBL, DRT, and LOS of Group B and Group C were significantly lower than those of Group A (P<0.05). The level of D-dimer (D-D) in Group C was significantly lower than that in Group A on the first day after the operation (P=0.002), and that in Group B was significantly lower than that in Group A on the third day after the operation (P=0.003). The interleukin-6 levels between the three groups from 1-5 days after the operation were in the order of Group A > Group B > Group C. No serious complications were observed in any patient. The results of multiple stepwise linear regression analysis revealed that PBL was positively correlated with incision length, IBL, smoking history, history of hypertension, preoperative fibrinogen degradation product (FDP) level, and blood transfusion. It was negatively correlated with preoperative levels of fibrinogen (FIB), red blood cells (RBCs), blood urea nitrogen (BUN), and age. Compared to female patients, male patients had an increased risk of PBL. Finally, the incidence of PBL was predicted. CONCLUSIONS Sequential application of multiple doses of TXA during the perioperative period could safely and effectively reduce PBL and TBL, shorten DRT and LOS, reduce postoperative D-D generation, and reduce the postoperative inflammatory response. In addition, this study provided a novel prediction model for PBL in patients undergoing PLIF.
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3.
Effect of postoperative tranexamic acid on recurrence rate and complications in chronic subdural hematomas patients: preliminary results of a randomized controlled clinical trial
de Paula Mvct, Ribeiro BDC, Melo MM, de Freitas PVV, Pahl FH, de Oliveira MF, Rotta JM
Neurosurgical review. 2023;46(1):90
Abstract
Chronic subdural hematoma (CSDH) is a frequent neurosurgical disease which mainly affects elderly patients. Tranexamic acid (TXA) has been hypothesized as an oral agent to avoid CSDH progression and/or recurrence. We performed an evaluation to determine whether the postoperative use of TXA reduces recurrence rate. A prospective, randomized, and controlled trial. Patients with unilateral or bilateral chronic subdural hematoma undergoing surgical treatment by burr-hole were randomized as to whether or not to use TXA in the postoperative period. We evaluated image and clinical recurrence of CSDH at follow up of 6 months and potential clinical and/or surgical complications impact of TXA. Twenty-six patients were randomized to the control group (52%) and twenty-four patients to the TXA group (48%). Follow-up ranged from 3 to 16 months. There were no significant difference between baseline data in groups regarding to age, gender, use of antiplatelet or anticoagulants, smoking, alcoholism, systemic arterial hypertension, diabetes mellitus, hematoma laterality, hematoma thickness, and drain use. Clinical and radiological recurrence occurred in three patients (6%), being two cases in TXA group (8.3%) and 1 in control group (3.8%). Postoperative complications occurred in two patients during follow-up (4%), being both cases in TXA group (8.3%), and none in the control group. Although TXA group had a higher recurrence rate (8.3%), there was no statistically significant difference between the two groups. Moreover, TXA group had two complications while control group had no complications. Although limited by experimental nature of study and small sample, our current data suggest that TXA should not be used as a potential agent to avoid recurrences of CSDH and might increase complication odds.
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4.
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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5.
Minimally Invasive Surgery With Thrombolysis for Intracerebral Hemorrhage Evacuation: Bayesian Re-analysis of a Randomized Controlled Trial
Bako, A. T., Potter, T., Pan, A. P., Tannous, J., Britz, G., Ziai, W. C., Awad, I., Hanley, D., Vahidy, F. S.
Neurology. 2023
Abstract
BACKGROUND AND OBJECTIVES Bayesian analysis of randomized controlled trials (RCTs) can extend the value of trial data beyond interpretations based on conventional p-value-based binary cutoffs. We conducted an exploratory post-hoc Bayesian re-analysis of the minimally invasive surgery with thrombolysis for intracerebral hemorrhage (ICH) evacuation (MISTIE-3) trial and derived probabilities of potential intervention effect on functional and survival outcomes. METHODS MISTIE-3 was a multicenter phase-3 RCT designed to evaluate the efficacy and safety of the MISTIE intervention. 506 adults (≥18 years) with spontaneous, non-traumatic, supratentorial ICH of ≥30mL were randomized to receive either the MISTIE intervention (n=255) or standard medical care (n=251). We provide Bayesian-derived estimates of the effect of the MISTIE intervention on achieving a good 365-day Modified Rankin Scale score (mRS score:0-3) as relative risk (RR) and absolute risk difference (ARD), and the probabilities that these treatment effects are greater than pre-specified thresholds. We used two sets of prior distributions: 1) reference priors, including minimally informative, enthusiastic, and skeptical priors; and 2) Data-derived prior distribution, using a hierarchical random-effects model. We additionally evaluated the potential effects of the MISTIE intervention on 180-day and 30-day mRS and 365, 180, and 30-day mortality using data-derived priors. RESULTS The Bayesian-derived probability that MISTIE intervention has any beneficial effect (RR>1) on achieving a good 365-day mRS score was 70% using minimally informative prior, 87% with enthusiastic prior; 68% with skeptical prior; and 73% with data-derived prior. However, these probabilities were ≤ 55% for RR>1.10, and 0% for RR>1.52 across a range of priors. The probabilities of achieving RR>1 for 180 and 30-day mRS scores are 65% and 80% respectively. Furthermore, the probabilities of achieving RR<1 for 365, 180, and 30-day mortality are 93%, 98%, and 99%, respectively. CONCLUSIONS Our exploratory analyses indicate that across a range of priors, the Bayesian-derived probability of MISTIE intervention having any beneficial effect on 365-day mRS for ICH patients is between 68% to 87%. These analyses do not change the frequentist-based interpretation of the trial. However, unlike the frequentist p-values, which indirectly evaluate treatment effects and only provide an arbitrary binary cut-off (such as 0.05), the Bayesian framework directly estimates probabilities of potential treatment effects. TRIAL REGISTRATION https://clinicaltrials.gov/ct2/show/NCT01827046 CLASSIFICATION OF EVIDENCE This study provides Class II evidence that minimally invasive surgery (MIS) + rt-PA does not significantly improve functional outcome in patients with intracerebral hemorrhage. However, The study lacks the precision to exclude a potential benefit of MIS + rt-PA.
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6.
Single dose of tranexamic acid effectively reduces blood loss in patients undergoing spine surgery: a prospective randomized controlled trial
Alejandro RS, Alejandro DS, Barón ZK, Javier GG, Rocío GGp, Huffman C, Luis M Ro, Armando AA, Carla LGr
World neurosurgery. 2023
Abstract
STUDY DESIGN Randomized control trial. OBJECTIVE Evaluate the efficacy of oral administration of tranexamic acid (TXA) in spine surgeries to achieve blood loss reduction. METHODS A total of 60 patients undergoing major surgery of the spine, were randomly assigned into 2 groups. Group 1 was assigned as the control group and the other one included oral administration of tranexamic acid 2 hours prior to surgery. Outcomes measures included intraoperative blood loss, postoperative blood loss, hematological parameters, blood transfusion needed, and surgical complications. RESULTS Sixty patients linked up with the inclusion criteria. Intraoperative blood loss was significantly lower in the TXA oral group than in the control group, total blood loss in the TXA group with 930.66±614ml lower than the control group with 1075.66±956.11ml. The mean reduction of hemoglobin was almost the same in both groups. Similarly, the total transfusion package received was lower, and the number of complications and length of stay were akin in both groups. A logistic regression model was performed with patients who had blood loss of more than 1000ml and, surgery time longer than 230min. This was related to the risk of bleeding with an OR of 1.31, 95%CI 1.004-1.023, p=0.004 independent of the group. CONCLUSION Oral TXA results as an effective measure for reducing total blood loss among patients undergoing elective spine surgery.
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The effect of sequential perioperative intravenous tranexamic acid in reducing postoperative blood loss and hidden blood loss after posterior lumbar interbody fusion: a randomized controlled trial
Dong, W., Liang, Y., Li, D., Ma, Z., Cheng, M., Zhang, X., Shen, J., Zhou, N., Hao, J., Jiang, W., et al
Frontiers in medicine. 2023;10:1192971
Abstract
BACKGROUND Tranexamic acid (TXA) has previously been shown to be effective in reducing intraoperative blood loss (IBL) and transfusion requirements in spine surgery. A conventional TXA regimen is a simple preoperative or intraoperative administration. However, the hyperfibrinolysis caused by surgical trauma lasts at least 24 h, and a single dose of TXA cannot cover the whole process of hyperfibrinolysis. Moreover, its ability to control postoperative blood loss (PBL) may be insufficient. Therefore, this study aimed to explore the effects and safety of sequential perioperative intravenous TXA for reducing bleeding after posterior lumbar interbody fusion (PLIF). METHODS Patients requiring PLIF were randomly divided into two groups. All patients were intravenously injected with 1 g of TXA 15 min before skin resection. Every day after the surgery, 200 ml saline was intravenously injected for 1-3 days in Group A, while Group B received 1 g of TXA instead of saline. The total blood loss (TBL), IBL, PBL, HCT, Hb, blood transfusion volume, inflammation-related indicators, and complications were recorded. RESULTS TBL, PBL, and hidden blood loss (HBL) in Group B were significantly lower than those in Group A (P < 0.05). The maximum decreases in HCT and Hb in Group B were also significantly lower than those in Group A (P < 0.05), and the drainage removal time (DRT) was sooner in Group B than in Group A (P = 0.003). On the 3rd and 5th days after surgery, the level of CRP in Group B was significantly lower than that in Group A (P < 0.05). Similarly, IL-6 levels were significantly lower in Group B for the first 5 days postoperatively (P < 0.001). Sex, operation time, level of decompression, length of incision, and change in HCT were significant predictors of both TBL and HBL. TBL was also significantly associated with BMI and preoperative fibrinogen, while postoperative TXA was a significant predictor of HBL only. CONCLUSION Intravenous injection of 1 g of TXA 15 min before skin resection combined with continuous intravenous injection of 1 g of TXA 1 to 3 days after PLIF can reduce postoperative bleeding and shorten the time to drainage tube removal. In addition, it can also inhibit the postoperative inflammatory response. CLINICAL TRIAL REGISTRATION ChiCTR2200056210.
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8.
Evaluating the Efficacy of Water-Soluble Bone Wax (Tableau Wax) in Reducing Blood Loss in Spinal Fusion Surgery: A Randomized, Controlled, Pilot Study
Kim, J. G., Ham, D. W., Zheng, H., Kwon, O., Kim, H. J.
Medicina (Kaunas, Lithuania). 2023;59(9)
Abstract
Background and Objectives: Lumbar decompression with fusion surgery is an effective treatment for spinal stenosis, but critical postoperative hematoma is a concern. Bone wax has been widely used to control bone bleeding but it has some drawbacks. This study aimed to evaluate the efficacy of Tableau wax, a bioabsorbable hemostatic material, in patients undergoing spinal fusion surgery through a pilot study design. Materials and Methods: A total of 31 patients were enrolled in this single-surgeon, single-institution study. The participants underwent transforaminal lumbar interbody fusion surgery and were randomly assigned to the control group (Bone wax) or test group (Tableau wax). Demographic data, pre- and post-operative hemoglobin levels, blood loss volume, surgical time, Oswestry Disability Index, and EQ-5D scores were recorded. Results: The study showed no significant difference in preoperative and postoperative hemoglobin levels, Oswestry Disability Index, and EQ-5D scores between the groups. However, the Tableau wax group had a significantly lower reduction in hemoglobin levels (1.3 ± 1.0 g/dL) and blood loss (438.2 mL) compared to the Bone wax group (2.2 ± 0.9 g/dL and 663.1 mL, respectively; p = 0.018 and p = 0.022).
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9.
Three-dimensional laser combined with C-arm computed tomography-assisted puncture of intracerebral hemorrhage
Zhao, H., Zhang, T., Li, M., Gao, Y., Wang, S., Jiang, R., Li, Z.
Frontiers in endocrinology. 2023;14:1198564
Abstract
BACKGROUND Intracerebral hemorrhage (ICH) is the deadliest subtype of stroke, with a 30-day case fatality rate of approximately 40%. Timely and accurate treatment is essential to facilitate recovery. The introduction of stereotactic instruments and navigation systems has greatly improved the accuracy of surgical treatment. In this study, we explored the application and effects of a three-dimensional (3D) laser combined with C-arm computed tomography (CT) on ICH puncture. MATERIALS AND METHODS According to the principle of randomness, 118 patients with ICH were divided into control and experimental groups. The control group was treated with CT-guided puncture, and the experimental group was treated with 3D laser combined with C-arm CT puncture. The hematoma clearance rates at 3, 5, and 7 days after surgery and the prognosis at 1, 3, and 6 months after surgery were compared between the two groups. RESULTS The hematoma clearance rates of the group using 3D laser combined with C-arm CT at 3, 5, and 7 days after surgery were significantly higher than those of the control group, and the difference was statistically significant (p < 0.05). One month postoperatively, the daily living ability (ADL) grading and recovery of the patients in the test group was significantly better than those of the control group (p < 0.05), but there was no statistically significant difference in ADL 3 and 6 months after surgery (p > 0.05). CONCLUSION 3D laser combined with C-arm CT puncture has the advantages of real-time guidance, accurate positioning, and simple operation. It is an effective minimally invasive surgical method that is easy to master.
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10.
Effect of acute normovolemic hemodilution on anesthetic effect, plasma concentration, and recovery quality in elderly patients undergoing spinal surgery
Liu, T., Bai, Y., Yin, L., Wang, J. H., Yao, N., You, L. W., Guo, J. R.
BMC geriatrics. 2023;23(1):689
Abstract
OBJECTIVE To explore the effect of acute normovolemic hemodilution (ANH) on the anesthetic effect, plasma concentration, and postoperative recovery quality in elderly patients undergoing spinal surgery. METHODS A total of 60 cases of elderly patients aged 65 to 75 years who underwent elective multilevel spinal surgery were assigned randomly into the ANH group (n = 30) and control group (n = 30). Hemodynamic and blood gas analysis indexes were observed and recorded before ANH (T(1)), after ANH (T(2)), immediately after postoperative autologous blood transfusion (T(3)), 10 min (T(4)), 20 min (T(5)), 30 min (T(6)), 40 min (T(7)), and 50 min (T(8)) after the transfusion, and at the end of the transfusion (i.e., 60 min; T(9)). At T(3 ~ 9), bispectral index (BIS) and train-of-four (TOF) stimulation were recorded and the plasma propofol/cisatracurium concentration was determined. The extubation time and recovery quality were recorded. RESULTS The ANH group presented a lower MAP value and a higher SVV value at T(2), and shorter extubation and orientation recovery time (P < 0.05) compared with the control group. BIS values at T(8) and T(9) were lower in the ANH group than those in the control group (P < 0.05). TOF values at T(7 ~ 9) were lower in the ANH group than those in the control group (P < 0.05). There were no statistically significant differences in the postoperative plasma concentrations of propofol and cisatracurium between the groups (P > 0.05). CONCLUSION During orthopedic surgery, the plasma concentration of elderly patients is increased after autologous blood transfusion of ANH, and the depth of anesthesia and muscle relaxant effect are strengthened, thus leading to delayed recovery of respiratory function and extubation.