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Fibrin Glue Sac Filling for Preventing Type II Endoleak, Short-Term Outcomes of a Prospective Randomized Controlled Trial
Chen Y, Zhang L, Liu Z, Bi J, Niu F, Zhang X, Lu Q, Dai X
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists. 2023;:15266028231159245
Abstract
OBJECTIVE Type II endoleak (T2EL) worsens the long-term results of endovascular aneurysm repair (EVAR). How to prevent T2ELs remains controversial. This study aimed to evaluate the efficacy and safety of fibrin glue sac filling (FGSF) to prevent T2ELs after EVAR. METHODS A prospective randomized controlled trial was conducted. Patients were randomly divided into group A (standard EVAR + FGSF) and group B (standard EVAR). The follow-up plans included outpatient or telephone consultation at 1 and 3 months and computed tomography (CT) angiography at 6 months, 1 year, and once a year after EVAR. RESULTS A total of 64 abdominal aortic aneurysm (AAA) patients were randomized to the 2 groups. All patients were followed up for more than 6 months. The 2 groups showed similar baseline characteristics. The rate of T2ELs on immediate angiography in group A (9.6%) was significantly lower than that in group B (33.3%, p=0.033). Moreover, the sac area change was significantly reduced in group A at 6 months after EVAR (p=0.021). However, T2EL incidence was similar at the 6-month (p=0.055) and 1-year (p=0.057) follow-ups, and AAA diameter change was also similar at 1 year. There were similar operation times, radiation doses, severe adverse events (SAEs), and reinterventions between the 2 groups. CONCLUSION Fibrin glue sac filling could prevent short-term type II endoleaks and promote AAA shrinkage after 6 months. The FGSF procedure is swift and straightforward; however, patients are at risk of bowel ischemia, especially after previous bowel resections or concomitant superior mesenteric artery (SMA) disease. CLINICAL IMPACT Standard endovascular aneurysm repair (EVAR) couldn't prevent type II endoleak (T2EL). In this study, we found fibrin glue sac filling (FGSF) could prevent T2EL and promote AAA shrinkage in a short term. And the FGSF procedure is easy, it will be a useful supplement to standard EVAR for clinicians. And FGSF might have potential usefulness on ruptured aneurysms, although without direct evidence.Fibrin glue is often used to hemostasis and tissue adhesion in surgical patients and burn patients, we firstly carry out a randomized controlled study and prove that fibrin glue sac filling could prevent T2EL and promote sac remodeling.
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Individualized red-cell transfusion strategy for non-cardiac surgery in adults: a randomized controlled trial
Liao R, Liu J, Zhang W, Zheng H, Zhu Z, Sun H, Yu Z, Jia H, Sun Y, Qin L, et al
Chinese medical journal. 2023
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Abstract
BACKGROUND Red-cell transfusion is critical for surgery during the peri-operative period; however, the transfusion threshold remains controversial mainly owing to the diversity among patients. The patient's medical status should be evaluated before making a transfusion decision. Herein, we developed an individualized transfusion strategy using the West-China-Liu's Score based on the physiology of oxygen delivery/consumption balance and designed an open-label, multicenter, randomized clinical trial to verify whether it reduced red cell requirement as compared with that associated with restrictive and liberal strategies safely and effectively, providing valid evidence for peri-operative transfusion. METHODS Patients aged >14 years undergoing elective non-cardiac surgery with estimated blood loss > 1000 mL or 20% blood volume and hemoglobin concentration <10 g/dL were randomly assigned to an individualized strategy, a restrictive strategy following China's guideline or a liberal strategy with a transfusion threshold of hemoglobin concentration <9.5 g/dL. We evaluated two primary outcomes: the proportion of patients who received red blood cells (superiority test) and a composite of in-hospital complications and all-cause mortality by day 30 (non-inferiority test). RESULTS We enrolled 1182 patients: 379, 419, and 384 received individualized, restrictive, and liberal strategies, respectively. Approximately 30.6% (116/379) of patients in the individualized strategy received a red-cell transfusion, less than 62.5% (262/419) in the restrictive strategy (absolute risk difference, 31.92%; 97.5% confidence interval [CI]: 24.42-39.42%; odds ratio, 3.78%; 97.5% CI: 2.70-5.30%; P<0.001), and 89.8% (345/384) in the liberal strategy (absolute risk difference, 59.24%; 97.5% CI: 52.91-65.57%; odds ratio, 20.06; 97.5% CI: 12.74-31.57; P<0.001). No statistical differences were found in the composite of in-hospital complications and mortality by day 30 among the three strategies. CONCLUSION The individualized red-cell transfusion strategy using the West-China-Liu's Score reduced red-cell transfusion without increasing in-hospital complications and mortality by day 30 when compared with restrictive and liberal strategies in elective non-cardiac surgeries. TRIAL REGISTRATION ClinicalTrials.gov, NCT01597232.
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Peri-articular administration of tranexamic acid is an alternative route in total knee arthroplasty: a systematic review and meta-analysis
Fan D, Ma J, Liu X, Zhang L
Journal of orthopaedic surgery and research. 2022;17(1):211
Abstract
BACKGROUND As an antifibrinolytic agent, tranexamic acid (TXA) is increasingly used in total knee arthroplasty (TKA) to reduce blood loss. The administration of intravenous and intra-articular TXA has been well explored, but the most efficient way to administer TXA remains in question. Peri-articular injection (PAI) of TXA is a recently mentioned method. A meta-analysis of the efficacy of PAI TXA in patients after TKA should be performed. METHODS A systematic search was performed within PubMed, Embase, and the Cochrane Library up to November 8, 2021. Two authors independently screened studies for eligibility and extracted data for analysis. The primary outcome was haemoglobin change. The secondary outcomes were haematocrit change, total drainage volume, thromboembolic events, and blood transfusion. RESULTS A total of ten studies were included in this meta-analysis. The results indicated that there was a significant decrease in haemoglobin change when using PAI TXA compared with no TXA (mean difference - 1.05; 95% CI - 1.28 to - 0.81; P < 0.00001; I(2) = 0%), but it had no significant differences compared with IA and IV (mean difference - 0.01; 95% CI - 0.17 to - 0.14; P = 0.85; I(2) = 39%). There were no significant differences between the TXA < 1.5 g subgroup (0.10, 95% CI - 0.27 to 0.46; P = 0.60; I(2) = 0%) and the TXA ≥ 1.5 g subgroup (0.18, 95% CI - 0.12 to 0.48; P = 0.24; I(2) = 74%). In addition, the combined group (PAI plus IV or IA) was superior to the IV or IA group in terms of haemoglobin change (mean difference - 0.51; 95% CI - 0.76 to - 0.27; P < 0.0001; I(2) = 19%). Regarding haematocrit change, the pooled result showed it was significantly less in the PAI group than the non-TXA group. Similarly, comparing it against the IV subgroup, the result revealed a difference in favour of the PAI group, with a mean difference of - 1.89 g/dL (95% CI - 2.82 to - 0.95; P < 0.0001; I(2) = 67%). For total drainage volume, the pooled result was in favour of PAI TXA over no TXA (297 ml, 95% CI - 497.26 to - 97.23; P = 0.004; I(2) = 87%), but it had no significant difference compared with IA and IV (mean difference - 37.98; 95% CI - 115.68 to 39.71; P = 0.34; I(2) = 95%). There was no significant difference in thromboembolic events (OR 0.74; 95% CI 0.25 to 2.21; P = 0.59; I(2) = 0%). Blood transfusion was not significantly different between the PAI group and the non-TXA group (OR 0.50; 95% CI 0.23 to 1.06; P = 0.07; I(2) = 21%), and there was no significant difference between PAI and the other two TXA injection methods (OR 0.72; 95% CI 0.41 to 1.25; P = 0.24; I(2) = 19%). CONCLUSION PAI has comparable effects to IV and IA injections. PAI is an alternative injection route of TXA for patients who have undergone TKA.
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The efficacy and safety of combined administration of intravenous and intra-articular tranexamic acid in total knee arthroplasty: An update meta-analysis
Ling T, Zhang L, Huang L
Journal of clinical pharmacy and therapeutics. 2022
Abstract
WHAT IS KNOWN AND OBJECTIVE This study was performed to compare the efficacy and safety of combined administration of intravenous (IV) and intra-articular (IA) tranexamic acid (TXA) with IV or IA TXA alone in total knee arthroplasty (TKA). METHODS PubMed, Embase, Cochrane Library and Web of Science were searched for randomized controlled trials (RCTs) in July 2021. Total blood loss, transfusion rate, postoperative haemoglobin drop, drain output, deep venous thrombosis (DVT) and pulmonary embolism (PE) were pooled. Data were analyzed using Stata 14.0 software. The study protocol was registered with PROSPERO, number CRD42020186654. RESULTS Ten RCTs involving 1306 patients were included. Combined TXA group provided lower total blood loss (SMD -0.47; 95% CI -0.64 to -0.30; p < 0.001), postoperative haemoglobin drop (SMD -0.47; 95% CI -0.60 to -0.33; p < 0.001) and drain output (SMD -0.50; 95% CI -0.71 to -0.29; p = 0.009) compared with IV or IA TXA alone group. No significant difference was found in terms of transfusion rate (OR 0.53; 95% CI 0.23 to 1.23; p = 0.137) and DVT (OR 0.55; 95% CI 0.18 to 1.68; p = 0.293). PE data was provided by all 10 studies, but PE only occurred in one patient in IV TXA alone group. WHAT IS NEW AND CONCLUSION Combined administration of IV and IA TXA was relatively more effective in reducing total blood loss, transfusion rate, postoperative haemoglobin drop, and drain output after TKA. TXA may not increase the risk of DVT/PE, but it also needs to be monitored in clinical application.
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Effect of prophylactic central neck dissection following total thyroidectomy on surgical site wound infection, hematoma, and haemorrhage in subjects with clinically node-negative papillary thyroid carcinoma: A meta-analysis
Jin L, Liu L, Wang J, Zhang L
International wound journal. 2022
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We performed a meta-analysis to evaluate the effect of prophylactic central neck dissection following total thyroidectomy on surgical site wound infection, hematoma, and haemorrhage in subjects with clinically node-negative papillary thyroid carcinoma. A systematic literature search up to April 2022 was performed and 3517 subjects with clinically node-negative papillary thyroid carcinoma at the baseline of the studies; 1503 of them were treated with prophylactic central neck dissection following total thyroidectomy, and 2014 were using total thyroidectomy. Odds ratio (OR) with 95% confidence intervals (CIs) were calculated to assess the effect of prophylactic central neck dissection following total thyroidectomy on surgical site wound infection, hematoma, and haemorrhage in subjects with clinically node-negative papillary thyroid carcinoma using the dichotomous method with a random or fixed-effect model. The prophylactic central neck dissection following total thyroidectomy subjects had a significantly lower surgical site wound infection (OR, 0.40; 95% CI, 0.20-0.78, P = .007) in subjects with clinically node-negative papillary thyroid carcinoma compared with total thyroidectomy. However, prophylactic central neck dissection following total thyroidectomy did not show any significant difference in hematoma (OR, 0.08; 95% CI, 0.43-2.71, P = .87), and haemorrhage (OR, 0.72; 95% CI, 0.26-1.97, P = .52) compared with total thyroidectomy in subjects with clinically node-negative papillary thyroid carcinoma. The prophylactic central neck dissection following total thyroidectomy subjects had a significantly higher surgical site wound infection, and no significant difference in hematoma, and haemorrhage compared with total thyroidectomy in subjects with clinically node-negative papillary thyroid carcinoma. The analysis of outcomes should be with caution because of the low number of studies in certain comparisons.
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Comparison of the Efficacy and Safety of Cell-Assisted Lipotransfer and Platelet-Rich Plasma Assisted Lipotransfer: What Should We Expect from a Systematic Review with Meta-Analysis?
Chen A, Zhang L, Chen P, Zhang C, Tang S, Chen X
Cell transplantation. 2021;30:963689721989607
Abstract
Due to the high absorption rate of traditional autologous fat grafting, cell-assisted lipotransfer (CAL) and platelet-rich plasma (PRP)-assisted lipotransfer were developed. The purpose of this article was to evaluate the efficacy and safety of CAL and PRP in promoting the survival of autologous fat grafting through systematic review and meta-analysis. We searched Pubmed, Cochrane Library, Web of Science, and EMBASE for clinical studies on CAL and PRP-assisted lipotransfer published from January 2010 to January 2020. Then a meta-analysis was performed to assess the efficacy of CAL and PRP-assisted lipotransfer through data analysis of fat survival rate. We also assessed the incidence of complications and multiple operations to analyze their safety. A total of 36 studies (1697 patients) were included in this review. Regardless of the recipient area, CAL and PRP-assisted lipotransfer significantly improved the fat survival rate (CAL vs non-CAL: 71% vs 48%, P < 0.0001; PRP vs non-PRP: 70% vs 40%, P < 0.0001; CAL vs PRP: 71% vs 70%, P = 0.7175). However, in large-volume fat grafting, such as breast reconstruction, both increased the incidence of complications and did not decrease the frequency of multiple operations after lipotransfer. Further prospective studies are needed to evaluate the clinical benefits of CAL and PRP-assisted lipotransfer.
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Evaluation of a novel Cardiac Peri-Operative Transfusion Trigger Scoring system in patients with coronary artery disease
Ma HP, Zhang L, Chen CL, Li J, Ma ZT, Jiang QQ, Liang YY, Li SS, Long F, Zheng H
BMC cardiovascular disorders. 2021;21(1):40
Abstract
BACKGROUND A simple and accurate scoring system to guide perioperative blood transfusion in patients with coronary artery disease (CAD) undergoing cardiac surgery is lacking. The trigger point for blood transfusions for these patients may be different from existing transfusion guidelines. This study aimed to evaluate the safety and efficacy of a new scoring strategy for use in guiding transfusion decisions in patients with CAD. METHODS A multicenter randomized controlled trial was conducted at three third-level grade-A hospitals from January 2015 to May 2018. Data of 254 patients in a Cardiac Peri-Operative Transfusion Trigger Score (cPOTTS) group and 246 patients in a group receiving conventional evaluation of the need for transfusion (conventional group) were analysed. The requirements for transfusion and the per capita consumption of red blood cells (RBCs) were compared between groups. RESULTS Baseline characteristics of the two groups were comparable. Logistic regression analyses revealed no significant differences between the two groups in primary outcomes (1-year mortality and perioperative ischemic cardiac events), secondary outcomes (shock, infections, and renal impairment), ICU admission, and ICU stay duration. However, patients in the cPOTTS group had significantly shorter hospital stays, lower hospital costs, lower utilization rate and lower per capita consumption of transfused RBCs than controls. Stratified analyses revealed no significant differences between groups in associations between baseline characteristics and perioperative ischemic cardiac events, except for hemofiltration or dialysis and NYHA class in I. CONCLUSIONS This novel scoring system offered a practical and straightforward guideline of perioperative blood transfusion in patients with CAD. Trial registration chiCTR1800016561(2017/7/19).
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Intravenous Tranexamic Acid Improves the Intraoperative Visualization of Endoscopic Sinus Surgery for High-Grade Chronic Rhinosinusitis: A Randomized, Controlled, Double-Blinded Prospective Trial
Yang W, Gou H, Li H, Liu Y, Wan Y, Wang C, Wang G, Zhang L
Frontiers in surgery. 2021;8:771159
Abstract
Objective: Intraoperative bleeding during endoscopic sinus surgery (ESS) for high-grade rhinosinusitis can be serious and can further obscure the surgical field. This study was designed to evaluate the effect of tranexamic acid (TXA) on the surgical visualization of ESS for high-grade rhinosinusitis. Methods: In total, 60 patients with high-grade chronic rhinosinusitis (Lund-Mackay score 12 or greater) treated by ESS were randomized into two groups: the control group (Group C) or the TXA group (Group T). Each group included 30 patients. Patients in Group T received intravenous TXA, and those in Group C received normal saline. The Boezaart grading scale (BS) score was assessed as the primary outcome. Total blood loss (TBL), whole blood coagulation, and fibrinolysis were assessed by Sonoclot analysis, and complications were recorded and compared between the groups. Result: A significant difference was found in the BS score between Group T and Group C [2.02 (1.88-2.05) vs. 2.27 (2.13-2.41), P = 0.011]. Increases in platelet function (PF) and fibrin degradation time (FDT) were assessed during the operation and showed significant differences between Group T and Group C (P = 0.040 for PF; P = 0.010 for FDT). No difference in complications was found between the two groups. Conclusion: A 15 mg/kg bolus of intravenous TXA before surgery can improve the surgical visualization of ESS for high-grade chronic rhinosinusitis without causing significant adverse effects. Intravenous TXA may be beneficial in ESS for high-grade chronic rhinosinusitis. Clinical Trial Registration: https://www.chictr.org.cn/edit.aspx?pid=121653&htm=4.
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Does subcutaneous administration of recombinant human erythropoietin increase thrombotic events in total hip arthroplasty? A prospective thrombelastography analysis
Ruan RX, Bai CW, Zhang L, Huang CR, Pan S, Zhang XC, Zhu ZY, Zheng X, Guo KJ
Journal of orthopaedic surgery and research. 2020;15(1):546
Abstract
BACKGROUND Anemia is one of severe complications in the perioperative period of total hip arthroplasty (THA). Erythropoietin (EPO) has been considered to improve patients' anemia state, but its efficiency and safety remains controversial. METHODS A total of 152 patients who underwent total hip arthroplasty from January 2017 to March 2019 were randomized to 2 groups. Recombinant human erythropoietin (rHu-EPO) group was treated with rHu-EPO subcutaneous injection 10000 IU after operation and once daily in the next week, while control group was treated with none extra treatment. Routine hematologic examination and thrombelastography (TEG) performed at different time point respectively. Doppler ultrasound for bilateral lower limbs was performed 1 day before surgery and 7 days after surgery. Auxiliary examination outcomes, blood transfusions outcomes, and postoperative complications were recorded as assessment indicators. RESULTS The difference in the relevant indexes of traditional coagulation and TEG values between two groups were not significantly. No significant difference was observed in the incidence of thromboembolism events and other complications between two groups during postoperative period. The amount of intraoperative blood loss was similar between the two groups. However, the postoperative use and dosage of allogeneic blood in the rHu-EPO group were lower than those in the control group. The hemoglobin and hematocrit level in the rHu-EPO group were higher than that in the control group after surgery. CONCLUSION Postoperative subcutaneous injection of rHu-EPO can improve hematological anemia-related parameters, reduce the use and dosage of allogeneic blood transfusions (ABTs), and has no significant influence on the formation of thrombosis and other complications in patients undergoing total hip arthroplasty in short term.
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Combined use of tranexamic acid and rivaroxaban in posterior lumbar interbody fusion safely reduces blood loss and transfusion rates without increasing the risk of thrombosis-a prospective, stratified, randomized, controlled trial
Zhang L, Li Y, Liu D, Xiao X, Guan T, Yue H, Xue H, Zhou H, Jiao G, Wu W, et al
Int Orthop. 2020
Abstract
PURPOSE This prospective, stratified, randomized, single-blind, placebo-controlled multicentre study investigated the safety and effectiveness of reducing blood loss and preventing venous thromboembolism (VTE) during posterior lumbar interbody fusion (PLIF) in patients with stenosis or spondylolisthesis using the combination of tranexamic acid (TXA) and rivaroxaban. METHODS The Autar score was evaluated in patients after admission. Patients with an Autar score ≤ 10 were randomized to group A or B. Group A was the placebo-controlled group. Patients in group B were treated with 1 g TXA via intravenous injection and 1 g TXA for external use. Patients with an Autar score > 10 were randomized to group C or D. Patients in group C were treated with 10-mg rivaroxaban qd for 35 days after surgery. Patients in group D received the same treatment as those in group B intra-operatively and as those in group C post-operatively. RESULTS A total of 599 patients from eight hospitals participated in this clinical trial. The total blood loss, intra-operative blood loss, and drainage volume were reduced by the administration of TXA (group A vs group B, P < 0.01; group C vs group D, P < 0.01), and the blood transfusion rate was also decreased (group A vs group B, P < 0.01; group C vs group D, P < 0.01). There were no significant differences (P > 0.05) in the VTE incidence rates among group A and group B. In patients with high-risk thrombosis, the number of patients with VTE was only three and seven after the application of rivaroxaban. Epidural haematoma was not discovered in any patients in our trial. CONCLUSION The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION ChiCTR-1800016430 2018-06-01.