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1.
Tourniquets can further reduce perioperative blood loss in patients on dexamethasone and tranexamic acid during cemented total knee arthritis: a single-center, double-blind, randomized controlled trial
Jiang W, Wang X, Xu H, Liu M, Xie J, Huang Q, Zhou R, Zhou Z, Pei F
Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology. 2023;24(1):17
Abstract
BACKGROUND Multiple doses of dexamethasone and tranexamic acid can inhibit postoperative inflammation and reduce fibrinolysis and perioperative blood loss in total knee arthroplasty. In this single-center, double-blind, randomized clinical trial, the aim was to investigate whether applying a tourniquet to patients on dexamethasone and tranexamic acid could further reduce perioperative blood loss. MATERIALS AND METHODS Patients who underwent cemented total knee arthroplasty at our hospital were randomized to receive a tourniquet (n = 71) or not (n = 70) during the procedure. All patients received multiple doses of dexamethasone and tranexamic acid perioperatively. The primary outcome was perioperative blood loss, while secondary outcomes were surgery duration, postoperative laboratory indices of inflammation and fibrinolysis, range of knee motion, VAS pain score, knee circumference, knee swelling rate, homologous transfusion, albumin use, and complications. RESULTS Using a tourniquet was associated with significantly lower intraoperative blood loss (P < 0.001) and total blood loss (P = 0.007) as well as significantly shorter surgery duration (P < 0.001). In contrast, the tourniquet did not significantly affect hidden blood loss, postoperative inflammation or fibrinolysis, range of knee motion, VAS pain score, knee circumference, knee swelling rate, homologous transfusion, albumin use, or complications. CONCLUSIONS The results of this randomized clinical trial demonstrate that applying a tourniquet during cemented total knee arthroplasty to patients receiving multiple doses of dexamethasone and tranexamic acid can further reduce perioperative blood loss without increasing the risk of inflammation, fibrinolysis, or other complications. Thus, it is advised to use tourniquets combined with dexamethasone and tranexamic acid to reduce perioperative blood loss and avoid tourniquet-related adverse events. LEVEL OF EVIDENCE Therapeutic Level I. Trial registration Chinese Clinical Trail Registry, ChiCTR2200060567. Registered 5 June 2022-retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=171291.
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2.
Effect of tourniquet use on blood loss, pain, functional recovery, and complications in robot-assisted total knee arthroplasty: a prospective, double-blinded, randomized controlled trial
Lai YH, Xu H, Su Q, Wan XF, Yuan MC, Zhou ZK
Journal of orthopaedic surgery and research. 2022;17(1):118
Abstract
BACKGROUND Robot-assisted total knee arthroplasty (TKA) has been largely studied to confirm its advantages in terms of accurate component positioning, microembolus formation, less blood loss, and so on, but is currently usually performed under tourniquet due to its longer operative time than conventional TKA. The aim of this study was to estimate the effects of tourniquet use in robot-assisted TKA on blood loss, pain, functional recovery, and complications. METHODS Patients scheduled for robot-assisted TKA were prospectively randomized into a tourniquet or non-tourniquet group (each n = 14). The primary outcome measure was blood loss. The secondary outcome measures were operation time; visual analog scale (VAS) pain scores; time to achieve the first straight-leg raise; swelling of the thigh, knee, and calf; range of motion; Hospital for Special Surgery score; length of stay; and postoperative complications. RESULTS There was no significant difference in total blood loss between the tourniquet and non-tourniquet groups (738.57 ± 276.158 vs. 866.85 ± 243.422 ml, P = 0.061). The tourniquet group showed significantly lower intraoperative blood loss (P < 0.001), but higher hidden blood loss (P = 0.002). The non-tourniquet group showed better knee range of motion on postoperative days (PODs) 1-3 (all P < 0.001), less thigh swelling on PODs 2 and 3 (P < 0.05), earlier straight-leg raising (P = 0.044), and shorter length of stay (P = 0.044). Thigh pain VAS score at 1 month after surgery was significantly greater in the tourniquet group (P < 0.001), as was knee pain during activity and at rest on PODs 2-3 (all P < 0.05). The tourniquet group also showed a significantly higher rate of tension blisters (28.8% vs. 7.1%, P = 0.038). CONCLUSIONS Tourniquet use during robot-assisted TKA does not reduce total blood loss, and it appears to increase postoperative pain, aggravate muscle injury, and prolong postoperative recovery. Trial registration ChiCTR, ChiCTR2100041800. Registered 5 January 2021, http://www.chictr.org.cn/index.aspx .
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3.
The effect of early vasopressin use on patients with septic shock: A systematic review and meta-analysis
Huang H, Wu C, Shen Q, Xu H, Fang Y, Mao W
The American journal of emergency medicine. 2021;48:203-208
Abstract
BACKGROUND The effect of early vasopressin initiation on clinical outcomes in patients with septic shock is uncertain. A systematic review and meta-analysis was performed to evaluate the impact of early start of vasopressin support within 6 h after the diagnosis on clinical outcomes in septic shock patients. METHODS We searched the PubMed, Cochrane, and Embase databases for randomized controlled trials (RCTs) and cohort studies from inception to the 1st of February 2021. We included studies involving adult patients (> 16 years)with septic shock. All authors reported our primary outcome of short-term mortality and in the experimental group patients in the studies receiving vasopressin infusion within 6 h after diagnosis of septic shock and in the control group patients in the studies receiving no vasopressin infusion or vasopressin infusion 6 h after diagnosis of septic shock, clearly comparing with clinically relevant secondary outcomes(use of renal replacement therapy(RRT),new onset arrhythmias, ICU length of stay and length of hospitalization). Results were expressed as odds ratio (OR) and mean difference (MD) with accompanying 95% confidence interval (CI). RESULTS Five studies including 788 patients were included. The primary outcome of this meta-analysis showed that short-term mortality between the two groups was no difference (odds ratio [OR] = 1.09; 95% CI, 0.8 to 1.48; P = 0.6; χ2 = 0.83; I2 = 0%). Secondary outcomes demonstrated that the use of RRT was less in the experimental group than that of the control group (OR = 0.63; 95% CI, 0.44 to 0.88; P = 0.007; χ2 = 3.15; I2 = 36%).The new onset arrhythmias between the two groups was no statistically significant difference (OR = 0.59; 95% CI, 0.31 to 1.1; P = 0.10; χ2 = 4.7; I2 = 36%). There was no statistically significant difference in the ICU length of stay(mean difference = 0.16; 95% CI, - 0.91 to 1.22; P = 0.77; χ2 = 6.08; I2 = 34%) and length of hospitalization (mean difference = -2.41; 95% CI, -6.61 to 1.78; P = 0.26; χ2 = 8.57; I2 = 53%) between the two groups. CONCLUSIONS Early initiation of vasopressin in patients within 6 h of septic shock onset was not associated with decreased short-term mortality, new onset arrhythmias, shorter ICU length of stay and length of hospitalization, but can reduce the use of RRT. Further large-scale RCTs are still needed to evaluate the benefit of starting vasopressin in the early phase of septic shock.
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4.
Effect of Multiple Doses of Intravenous Tranexamic Acid on Perioperative Blood Loss in Total Knee Arthroplasty: A Randomized Controlled Study
Kang BX, Li YL, Xu H, Gao CX, Zhong S, Zhang J, Xie J, Sun ST, Xu XR, Zhao C, et al
Orthopaedic surgery. 2021;13(1):126-133
Abstract
OBJECTIVE To identify the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) following primary total knee arthroplasty (TKA) with a tourniquet. METHODS This is a single-blind randomized controlled study that recruited osteoarthritis patients who had undergone primary unilateral TKA from May 2019 to May 2020 at our medical center. A total of 300 patients were randomly divided into three groups to receive: one dose (1 g) of IV-TXA before skin incision combined with one dose (1.5 g) of intra-articular tranexamic acid(IA-TXA) followed by a single dose of IV-TXA (1 g) for 3 h (group A); two doses of IV-TXA (1 g) for 3 and 6 h (group B); or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group C) postoperatively. TKA with a tourniquet was performed by the same surgical team. The primary outcomes were total blood cell loss (TBL), hidden blood loss (HBL), maximum hemoglobin (Hb) drop, and transfusion rate. Secondary outcomes were levels of C-reactive protein (CRP) and D-dimer, and the incidence of postoperative complications. One-way analysis of variance, subgroup analysis, and multivariate correlation analysis were used to calculate the differences among the three groups. RESULTS The study included 56 male and 244 female patients aged 60-80 years. The mean TBL, the mean HBL, and the maximum Hb drop in group C (471.2 ± 190.6 mL, 428.4 ± 190.3 mL, and 21.2 ± 3.8 g/L, respectively) were significantly lower than those in groups B (563.4 ± 224.6 mL, P = 0.030; 519.9 ± 226.4 mL, P = 0.033; and 23.2 ± 4.1 g/L, P = 0.001, respectively), and A (651.6 ± 254.1 mL, P < 0.001; 607.1 ± 254.3 mL, P < 0.001; and 25.1 ± 4.3 g/L, P < 0.001, respectively). No transfusions were required. The postoperative acute inflammatory reaction was less problematic for patients in Group C, and the incidence of thromboembolic events was similar among the groups (P > 0.05). In addition, there were positive correlations between the HBL and the tourniquet inflation time (r = 0.844, P < 0.001). Similarly, the level of CRP on POD1 (r = 0.393, P < 0.001) and POD3 (r = 0.149, P = 0.010), and the level of D-dimer on POD1 (r = 0.382, P < 0.001) were positively correlated with the HBL. CONCLUSION Three doses of postoperative IV-TXA decreased blood loss and diminished the postoperative inflammatory and fibrinolytic response more than a single dose or two doses in elderly patients following TKA without increasing the incidence of adverse events.
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5.
Multiple intravenous tranexamic acid doses in total knee arthroplasty in patients with rheumatoid arthritis: a randomized controlled study
Kang BX, Xu H, Gao CX, Zhong S, Zhang J, Xie J, Sun ST, Ma YH, Xu XR, Zhao C, et al
BMC musculoskeletal disorders. 2021;22(1):425
Abstract
BACKGROUND We aimed to determine the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA) who had undergone primary unilateral total knee arthroplasty (TKA). METHODS For this single-center, single-blind randomized controlled clinical trial, 10 male and 87 female participants with RA, aged 50-75 years, who underwent unilateral primary TKA were recruited. The patients received one dose of 1 g IV-TXA 10 min before skin incision, followed by articular injection of 1.5 g tranexamic acid after cavity suture during the surgery. The patients were randomly assigned (1:1) into two groups and received an additional single dose of IV-TXA (1 g) for 3 h (group A) or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group B) postoperatively. Primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and maximum hemoglobin (Hb) level decrease. Secondary outcomes were transfusion rate and D-dimer levels. All parameters were measured postoperatively during inpatient hospital stay. RESULTS The mean TBL, HBL, and maximum Hb level decrease in group B (506.1 ± 227.0 mL, 471.6 ± 224.0 mL, and 17.5 ± 7.7 g/L, respectively) were significantly lower than those in group A (608.8 ± 244.8 mL, P = 0.035; 574.0 ± 242.3 mL, P = 0.033; and 23.42 ± 9.2 g/L, P = 0.001, respectively). No episode of transfusion occurred. The D-dimer level was lower in group B than in group A on postoperative day 1 (P < 0.001), and the incidence of thromboembolic events was similar between the groups (P > 0.05). CONCLUSION In patients with RA, three doses of postoperative IV-TXA further facilitated HBL and Hb level decrease without increasing the incidence of adverse events in a short period after TKA. TRIAL REGISTRATION The trial was registered in the Chinese Clinical Trial Registry ( ChiCTR1900025013 ).
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6.
Synergistic Effect of a Prolonged Combination Course of Tranexamic Acid and Dexamethasone Involving High Initial Doses in Total Knee Arthroplasty: A Randomized Controlled Trial
Xu H, Xie J, Yang J, Huang Z, Wang D, Pei F
The journal of knee surgery. 2021
Abstract
The optimal regimes of tranexamic acid (TXA) and dexamethasone (DXM) in total knee arthroplasty (TKA) are still uncertain. The aim of this study was to assess the efficacy and safety of a prolonged course of intravenous TXA and DXM involving a high initial dose in TKA. Patients who underwent primary TKA at our center were randomized to receive one of four regimes: control (group A), prolonged course of TXA (B), prolonged course of DXM (C), or the combination of a prolonged course of TXA and DXM (D). The four groups were compared in primary outcomes (fibrinolytic and inflammatory markers, knee function, postoperative pain levels, and consumption of opioids) and secondary outcomes (blood loss, maximal drop in hemoglobin, coagulation, fasting blood glucose, and complications). A total of 162 patients were enrolled. On postoperative days 2 and 3, fibrinolytic markers were lower in groups B and D than in groups A and C; inflammatory markers were lower in groups C and D than in groups A and B. Inflammatory markers were lower in group B than in group A on postoperative day 3. Postoperative pain levels and oxycodone consumption were lower, and knee function was better in groups C and D. The four groups did not differ in any of the secondary outcomes. A prolonged course of intravenous TXA and DXM involving high initial doses can effectively inhibit postoperative fibrinolytic and inflammatory responses, reduce pain, and improve knee function after TKA.
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7.
Tranexamic acid attenuates inflammatory effect and modulates immune response in primary total knee arthroplasty: a randomized, placebo-controlled, pilot trial
Zhang S, Xu H, Xie J, Cao G, Lei Y, Pei F
Inflammopharmacology. 2020
Abstract
AIMS: To explore the effect of intravenous tranexamic acid (IV-TXA) on inflammation and immune response following primary total knee arthroplasty (TKA). METHODS Primary TKA patients (n = 125) were randomized into the following four groups: group A to receive placebo; group B to receive a single dose of 20 mg kg(-1) IV-TXA and 20 mg of intravenous dexamethasone (IV-DXM); group C to receive six doses of IV-TXA (total dosage > 6 g); and group D to receive six doses of IV-TXA combined with three doses of IV-DXM (total dosage = 40 mg). The primary outcomes were C-reactive protein (CRP) and interleukin (IL)-6 levels and the secondary outcomes were complement C3 and C4 and T-cell subset levels, which were measured preoperatively and at 24 h, 48 h, 72 h, and 2 weeks postoperatively. RESULTS The postoperative peak CRP and IL-6 levels in group C (93.7 +/- 22.2 mg L(-1), 108.8 +/- 41.7 pg mL(-1)) were lower compared with those in group A (134.7 +/- 28.8 mg L(-1), P < 0.01; 161.6 +/- 64.4 pg mL(-1), P < 0.01). Groups B and D exhibited significantly lower CRP and IL-6 levels compared with groups A and C at 24 h, 48 h, and 72 h postoperatively (P < 0.05 for all). In group C, complement C3 and C4 levels were higher compared with those in group A at 48 h (0.967 +/- 0.127 g L(-1) vs. 0.792 +/- 0.100 g L(-1), P < 0.01; 0.221 +/- 0.046 g L(-1) vs. 0.167 +/- 0.028 g L(-1), P < 0.01) and 72 h (1.050 +/- 0.181 g L(-1) vs. 0.860 +/- 0.126 g L(-1), P = 0.01; 0.240 +/- 0.052 g L(-1) vs. 0.182 +/- 0.036 g L(-1), P < 0.01) postoperatively and CD3 and CD4 subset levels were higher compared with those in group B at 24 h postoperatively (66.78 +/- 9.29% vs. 56.10 +/- 12.47%, P < 0.05; 36.69 +/- 5.78% vs. 28.39 +/- 8.89%, P < 0.05). CONCLUSION Six doses of IV-TXA could attenuate the inflammatory effect, modulate the immune response, and reduce immunosuppression caused by DXM in patients after TKA.
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8.
[Efficacy and safety of a loading high-dose tranexamic acid followed by postoperative five doses in total hip arthroplasty: A randomized controlled trial]
Cui D, Lei Y, Xu H, Huang Q, Pei F
Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery. 2019;33(8):935-939
Abstract
Objective: To evaluate the efficacy and safety of a loading high-dose tranexamic acid (TXA) followed by postoperative 5 doses in total hip arthroplasty (THA) by a randomized controlled trial. Methods: Seventy-two patients who underwent primary unilateral THA between December 2017 and March 2018 were randomly divided into two groups (36 patients in each group). A single dose of 20 mg/kg TXA was administered intravenously before 5-10 minutes of operation in group A; and a single dose of 40 mg/kg TXA was administered intravenously in group B at the same time point. All patients received 5 doses of 1 g TXA at 3, 6, 12, 18, and 24 hours after the first dose. There was no significant difference in gender, age, weight, height, body mass index, disease type, and combined medical diseases between the two groups ( P>0.05). Total blood loss (TBL), lowest postoperative hemoglobin (Hb) level, fibrinolysis parameters [fibrin (ogen) degradation products (FDP), D-dimer], inflammatory factors [C-reaction protein (CRP), interleukin-6 (IL-6)], adverse events (thrombosis, pulmonary embolism) were recorded and compared between groups. Results: The TBL was significantly lower in group B than in group A ( P<0.05). Furthermore, the lowest postoperative Hb level was significantly higher in group B than in group A ( P<0.05). There was no significant difference in FDP and D-dimer before operation between the two groups ( P>0.05). The levels of FDP and D-dimer were significantly lower in group B than in group A at 12 and 36 hours postoperatively ( P<0.05). There was no significant difference in CRP and IL-6 before operation between the two groups ( P>0.05). The levels of CRP and IL-6 were significant lower in group B than in group A at 12, 24, and 36 hours postoperatively ( P<0.05). There was no significant difference at 14 days ( P>0.05). There were 2 patients with intramuscular venous thrombosis in group A and 1 in group B after operation, and there was no significant difference in the incidence of embolic events ( P>0.05). No deep venous thrombosis or pulmonary embolism occurred in all groups. Conclusion: A loading high-dose TXA followed by postoperative 5 doses can further reduce the blood loss, provide additional fibrinolysis and inflammation control in THA, without increasing the risk of embolic events.
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9.
The Efficacy of Ferumoxytol for Iron Deficiency Anemia: A Meta-Analysis of Randomized Controlled Trials
Shao Y, Luo W, Xu H, Zhang L, Guo Q
Acta haematologica. 2019;:1-7
Abstract
INTRODUCTION This systematic review and meta-analysis aims to explore the influence of ferumoxytol versus placebo on iron deficiency anemia. METHODS We search for randomized controlled trials (RCTs) assessing the effect of ferumoxytol on iron deficiency anemia on PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases. This meta-analysis is performed using the random-effects model. RESULTS Four RCTs are included in the meta-analysis. Compared with the control group for iron deficiency anemia, intravenous ferumoxytol can significantly improve the proportion of patients with a ≥20 g/L hemoglobin (Hb) increase (RR = 18.43; 95% CI = 7.29-46.57; p < 0.00001), the proportion of patients with an Hb level ≥120 g/L (RR = 18.55; 95% CI = 8.66-39.72; p < 0.00001), transferrin saturation (mean difference = 11.08; 95% CI = 9.86-12.31; p < 0.00001) and FACIT-fatigue score (mean difference = 4.60; 95% CI = 3.21-6.00; p < 0.00001), but has no remarkable influence on adverse events (RR = 1.33; 95% CI = 0.84-2.10; p = 0.22), serious adverse events (RR = 1.22; 95% CI = 0.74-2.02; p = 0.44), and death (RR = 0.32; 95% CI = 0.05-1.95; p = 0.22). CONCLUSIONS Intravenous ferumoxytol can provide the important benefits for iron deficiency anemia.
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10.
Intravenous Iron Versus Placebo in the Management of Postoperative Functional Iron Deficiency Anemia in Patients Undergoing Cardiac Valvular Surgery: A Prospective, Single-Blinded, Randomized Controlled Trial
Xu H, Duan Y, Yuan X, Wu H, Sun H, Ji H
Journal of cardiothoracic and vascular anesthesia. 2019
Abstract
OBJECTIVE To compare the efficacy of intravenous iron versus placebo to correct postoperative functional iron deficiency anemia in patients undergoing cardiac valvular surgery. DESIGN A prospective, single-blinded, randomized controlled study. SETTING National Center for Cardiovascular Diseases and a university hospital. PARTICIPANTS The study comprised 150 patients with postoperative functional iron deficiency anemia after cardiac valvular surgery. INTERVENTIONS The patients were randomly assigned (1:1) to either the treatment (intravenous iron) group or the control (placebo) group. MEASUREMENTS AND MAIN RESULTS The hemoglobin and ferritin concentrations and postoperative adverse events were collected and compared between the 2 groups. The hemoglobin concentration and the proportion of patients who had their anemia corrected or achieved hemoglobin increments of >20g/L in the intravenous iron group were significantly higher than that in the placebo group at postoperative day 14 (p=0.023, p=0.037, and p=0.001), whereas there was no statistical difference at postoperative day 7. The ferritin concentration was substantially higher at postoperative day 7 and postoperative day 14 in the intravenous iron group compared with the placebo group (both p < 0.001). There were no significant differences in rates of death, blood tranfusion, antibiotic upgrade, ventilator time >24hours, postoperative hospital stay >10days, poor wound healing, and perivalvular leakage between the 2 groups. CONCLUSIONS Intravenous iron could significantly increase the hemoglobin level in patients with postoperative functional iron deficiency anemia at postoperative day 14. However, there is no difference in blood transfusion requirements or postoperative adverse outcomes between the 2 groups.