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1.
An Individualized Red Blood Cell Transfusion Strategy Using Pediatric Perioperative-Transfusion-Trigger Score Reduced Perioperative Blood Exposure for Children: A Randomized Controlled Clinical Trial
Luo Z, Li Y, Li X, Liao R
Therapeutics and clinical risk management. 2023;19:229-237
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Editor's Choice
Abstract
OBJECTIVE The optimal red blood cell transfusion strategy for children remains unclear. We developed an individualized red blood cell transfusion strategy for children and tested the hypothesis that transfusion guided by this strategy could reduce blood exposure, without increasing perioperative complications in children. METHODS In this randomized controlled clinical trial, 99 children undergoing noncardiac surgeries who had blood loss of more than 20% total blood volume were randomly assigned to an individualized-strategy group using Pediatric Perioperative-Transfusion-Trigger Score or a control group. The amount of transfused red blood cell was counted, and patients were followed up for postoperative complications within 30 days. RESULTS Twenty-six children (53.1%) in the individualized-strategy group received transfusion perioperatively, as compared with 37 children (74%) in the control group (p < 0.05). During surgery, children in the individualized-strategy group were exposed to fewer transfusions than in the control group (0.87±1.03 vs 1.33±1.20 Red-Blood-Cell units per patient, p = 0.02). The incidence of severe complications in the individualized-strategy group had a lower trend compared to the control group (8.2% vs 18%, p = 0.160). No significant difference was found in the other outcomes. CONCLUSION This trial proved that red blood cell transfusion guided by the individualized strategy reduced perioperative blood exposure in children, without increasing the incidence of severe complications. This conclusion needs to be reaffirmed by larger-scale, multicenter clinical trials.
PICO Summary
Population
Children undergoing non-cardiac surgery who had blood loss of more than 20% total blood volume (n= 99).
Intervention
Individualized red blood cell (RBC) transfusion strategy using Pediatric Perioperative-Transfusion-Trigger Score (individualized-strategy group, n= 49).
Comparison
RBC transfusion initiated when the patient’s haemoglobin concentration was lower than 8g per deciliter, or lower than 10g per deciliter for newborns (control group, n= 50).
Outcome
Twenty-six children (53.1%) in the individualized-strategy group received transfusion perioperatively, as compared with 37 children (74%) in the control group. During surgery, children in the individualized-strategy group were exposed to fewer transfusions than in the control group (0.87±1.03 vs. 1.33±1.20 red blood cell units per patient). The incidence of severe complications in the individualized-strategy group had a lower trend compared to the control group (8.2% vs. 18%). No significant difference was found in the other outcomes.
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Clinical application of platelet-rich fibrin to enhance dental implant stability: A systematic review and meta-analysis
Guan S, Xiao T, Bai J, Ning C, Zhang X, Yang L, Li X
Heliyon. 2023;9(2):e13196
Abstract
OBJECTIVE To investigate the effect of platelet-rich fibrin application on implant stability. STUDY DESIGN Five databases, namely, PubMed, Embase, Web of Science, Wiley, and China National Knowledge Infrastructure, were searched for reports published up to November 20, 2022. Randomized controlled trials (RCT), including parallel RCTs and split-mouth RCTs, with at least 10 patients/sites were considered for inclusion. RESULTS After screening based on the inclusion criteria, ten RCTs were included. Low heterogeneity was observed in study characteristics, outcome variables, and estimation scales (I(2) = 27.2%, P = 0.19). The qualitative and meta-analysis results showed that PRF increased the effect of implant stabilizers after implant surgery. CONCLUSIONS The results of the present systematic review and meta-analysis suggest that PRF can increase implant stability after implant surgery. PRF may also have a role in accelerating bone healing and tends to promote new bone formation at the implant site.
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The Fragility of Tourniquet Use in Total Knee Arthroplasty: A Systematic Review of Randomized Controlled Trials
Cordero JK, Lawrence KW, Brown A, Li X, Hayden BL, Parisien RL
The Journal of arthroplasty. 2022
Abstract
BACKGROUND Physicians utilize P-values to interpret clinical trial data and guide patient-care decisions. Fragility analysis assesses the stability of statistical findings in relation to outcome event reversals. This study assessed the statistical fragility of recent randomized controlled trials (RCTs) investigating tourniquet use in total knee arthroplasty (TKA). METHODS We queried PubMed/EMBASE/MEDLINE for RCTs comparing outcomes in TKA based on tourniquet-use. Fragility index (FI) and reverse fragility index (reverse FI) were calculated - for significant and non-significant outcomes, respectively - as the number of outcome reversals required to change statistical significance. The fragility quotient (FQ) was calculated by dividing the FI or reverse FI by the sample size. Median overall FI and FQ were calculated for all included outcomes, and sub-analyses were performed by reported significance. The literature search yielded 23 studies reporting 91 total dichotomous outcomes. RESULTS Overall median FI was 4 with an interquartile range (IQR) of 3 to 6. Overall median FQ was 0.0476 (IQR 0.0291 to 0.0867). A total of 11 outcomes were statistically significant with a median FI and FQ of 2 (IQR 1.5 to 5) and 0.0200 (IQR 0.0148 to 0.0484), respectively. There were 80 outcomes that were non-significant with a median reverse FI of 4 (IQR 3 to 6). Loss to follow-up was greater than the median FI in 17.6% of outcomes. CONCLUSIONS Altering a small number of outcomes is often sufficient to reverse findings in RCTs evaluating tourniquet use in TKA. We recommend including fragility analyses to increase reliability in the interpretation of study conclusions.
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A comparative study on the efficacy of robot of stereotactic assistant and frame-assisted stereotactic drilling, drainage for intracerebral hematoma in patients with hypertensive intracerebral hemorrhage
Liang L, Li X, Dong H, Gong X, Wang G
Pakistan journal of medical sciences. 2022;38(7):1796-1801
Abstract
OBJECTIVES To compare the clinical efficacy of robot of stereotactic assistant (ROSA) and frame-assisted stereotactic drilling and drainage for intracerebral hematoma in hypertensive intracerebral hemorrhage (HICH). METHODS A total of 142 patients with HICH treated in Baoding First Central Hospital from January 2018 to January 2020 were selected and divided into two groups using a random number table. The ROSA group was treated with a robot of stereotactic assistant, while the frame group underwent frame-assisted stereotactic drilling and drainage for intracerebral hematoma. Surgical duration, postoperative extubation time and complications were compared between the two groups. Venous blood (5 mL) was collected before and three days after surgery. The levels of inflammatory factors [tumor necrosis factor-α (TNF-α), high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6)], as well as neurological function indexes [neuron-specific enolase (NSE), nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF)] were detected by enzyme-linked immunosorbent assay. RESULTS The surgical duration, postoperative extubation time, and incidences of infection and postoperative rehemorrhage in the ROSA group were lower than those in the frame group (P < 0.05). In the ROSA group, postoperative TNF-α, hs-CRP, IL-6 and NSE levels were significantly lower while NGF and BDNF levels were higher than those in the frame group (all P < 0.05). CONCLUSION Compared with frame-assisted stereotactic drilling and drainage for intracerebral hematoma, ROSA in HICH treatment shortens the surgical duration and postoperative extubation time, reduces the risks of infection and rehemorrhage and decreases inflammatory level, which is helpful for the recovery of neurological function.
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The Statistical Fragility of Platelet-Rich Plasma in Rotator Cuff Surgery: A Systematic Review and Meta-analysis
Parisien RL, Ehlers C, Cusano A, Tornetta P 3rd, Li X, Wang D
The American journal of sports medicine. 2021;:363546521989976
Abstract
BACKGROUND The practice of evidence-based medicine relies on objective data to guide clinical decision-making with specific statistical thresholds conveying study significance. PURPOSE To determine the utility of applying the fragility index (FI) and the fragility quotient (FQ) analysis to randomized controlled trials (RCTs) evaluating the utilization of platelet-rich plasma (PRP) in rotator cuff repairs (RCRs). STUDY DESIGN Systematic review and meta-analysis. METHODS RCTs pertaining to the utilization of PRP in surgical RCRs published in 13 peer-reviewed journals from 2000 to 2020 were evaluated. The FI was determined by manipulating each reported outcome event until a reversal of significance was appreciated. The associated FQ was determined by dividing the FI by the sample size. RESULTS Of the 9746 studies screened, 19 RCTs were ultimately included for analysis. The overall FI incorporating all 19 RCTs was only 4, suggesting that the reversal of only 4 events is required to change study significance. The associated FQ was determined as 0.092. Of the 43 outcome events reporting lost to follow-up data, 13 (30.2%) represented lost to follow-up >4. CONCLUSION Our analysis suggests that RCTs evaluating PRP for surgical RCRs may lack statistical stability with only a few outcome events required to alter trial significance. Therefore, we recommend the reporting of an FI and an FQ in conjunction with P value analysis to carefully interpret the integrity of statistical stability in future comparative trials. CLINICAL RELEVANCE Clinical decisions are often informed by statistically significant results. Thus, a true understanding of the robustness of the statistical findings informing clinical decision-making is of critical importance.
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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
Li X, Jiao G, Li J, Ji W, Hao Z, Gong F, Chen Y
Global spine journal. 2021;:21925682211024556
Abstract
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.
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Association between preoperative blood transfusion and postoperative venous thromboembolism: Review meta-analysis
Wang C, Kou H, Li X, Lan J
Annals of vascular surgery. 2020
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Full text
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Editor's Choice
Abstract
OBJECTIVES Several studies have shown that preoperative blood transfusion is associated with postoperative venous thromboembolism (VTE). In this study, a meta-analysis was performed to explore the relationship between preoperative blood transfusion and postoperative VTE. METHODS Published articles were identified through a comprehensive review of PUBMED and EMBASE. Data from studies reporting relative risks, odds ratios, or hazard ratios comparing the risk of postoperative VTE among participants who had preoperative blood transfusion versus those without preoperative blood transfusion were analyzed. A random-effect model was used to calculate pooled odds ratios and 95% confident intervals (CI). RESULTS Eight studies, which included 3,504,778 participants, aligned with our inclusion criteria, and were included in the meta-analysis. Pooled analysis showed an association between preoperative blood transfusion and postoperative VTE, with an odds ratio of 2.95 (95%CI, 1.65, 5.30; I(2) = 89.1%). In subgroup analyses, the positive association between preoperative blood transfusion and postoperative VTE were still exist in studies with confounders adjustment. Sensitivity analysis by one-study removed analysis confirmed the robustness of our results. CONCLUSIONS Our study indicated that preoperative blood transfusion was associated with higher odds of postoperative VTE. Further large-scale prospective cohort studies are needed to investigate the causality between preoperative blood transfusion and postoperative VTE.
PICO Summary
Population
Patients undergoing surgery (8 studies, n= 3,504,778).
Intervention
Preoperative blood transfusion.
Comparison
Without preoperative blood transfusion.
Outcome
Pooled analysis showed an association between preoperative blood transfusion and postoperative venous thromboembolism (VTE). In subgroup analyses, the positive association between preoperative blood transfusion and postoperative VTE still existed in studies with confounders adjustment.
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Efficacy and toxicities of low-temperature plasma radiofrequency ablation for the treatment of laryngomalacia in neonates and infants: a prospective randomized controlled trial
Xu H, Chen F, Zheng Y, Li X
Annals of translational medicine. 2020;8(21):1366
Abstract
BACKGROUND Laryngomalacia is the most common cause of stridor in neonates and infants, and supraglottoplasty is the mainstay of surgical treatment. Although low-temperature plasma radiofrequency ablation (LTP-RFA) using coblation technology has been used for treating laryngomalacia, it is still lack of high-quality clinical evidence. Therefore, we conduct this prospective randomized study to clearly define the role of LTP-RFA for the treatment of laryngomalacia in neonates and infants. METHODS Between Jan 2017 and Dec 2019, a total of 89 children with laryngomalacia were included for analysis. All patients were initially stratified according to the severity of laryngomalacia. Patients with severe laryngomalacia were randomly assigned to receive LTP-RFA or traditionally surgical supraglottoplasty, while patients with moderate laryngomalacia were assigned to LTP-RFA or observation. The primary end point was the efficacy and toxicities of LTP-RFA by assessing the changes of clinical score and visual analogue scale (VAS) symptom score. The total score was the combination of clinical score with VAS score. RESULTS Of the 89 children, 40 children presented with severe laryngomalacia, and the remaining 49 children were diagnosed as moderate laryngomalacia. The median age was 68 days (range, 19 to 337 days). For children with severe laryngomalacia, our results showed that LTP-RFA treatment significantly reduced the operative time (5.55±1.66 vs. 18.7±5.31 min, P<0.001), length of hospital stay (6.71±1.15 vs. 7.95±1.55 days, P=0.008) and the amount of intraoperative hemorrhage (1.71±1.79 vs. 4.90±1.82, P<0.001) when compared to traditionally surgical supraglottoplasty, while the treatment efficacy was comparable between LTP-RFA and traditionally surgical supraglottoplasty in terms of changed total score (P=0.322), changed clinical score (P=0.135) and changed VAS symptom score (P=0.559). Additionally, for children with moderate laryngomalacia, LTP-RFA treatment significantly improved the symptom evaluated by total score (P<0.001), clinical score (P<0.001) and VAS symptom score (P<0.001) in comparison with the observation group. Post-operative pneumonia was observed in 10 patients. No surgical related death was reported. CONCLUSIONS The present study indicated that LTP-RFA was an effective treatment option for both severe and moderate laryngomalacia in neonates and infants with a low intraoperative complication. Long-term outcomes of LTP-RFA for laryngomalacia would be reported in further studies.
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Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial
Lv Y, Yang Z, Liu L, Li K, He C, Wang Z, Bai W, Guo W, Yu T, Yuan X, et al
The lancet. Gastroenterology & hepatology. 2019
Abstract
BACKGROUND The survival benefit of early placement of transjugular intrahepatic portosystemic shunts (TIPS) in patients with cirrhosis and acute variceal bleeding is controversial. We aimed to assess whether early TIPS improves survival in patients with advanced cirrhosis and acute variceal bleeding. METHODS We did an investigator-initiated, open-label, randomised controlled trial at an academic hospital in China. Consecutive patients with advanced cirrhosis (Child-Pugh class B or C) and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy were randomly assigned (2:1) to receive either early TIPS (done within 72 h after initial endoscopy [early TIPS group]) or standard treatment (vasoactive drugs continued to day 5, followed by propranolol plus endoscopic band ligation for the prevention of rebleeding, with TIPS as rescue therapy when needed [control group]). Randomisation was done by web-based randomisation system using a Pocock and Simon's minimisation method with Child-Pugh class (B vs C) and presence or absence of active bleeding as adjustment factors. The primary outcome was transplantation-free survival, analysed in the intention-to-treat population, excluding individuals subsequently found to be ineligible for enrolment. This study is registered with ClinicalTrials.gov, number NCT01370161, and is completed. FINDINGS From June 26, 2011, to Sept 30, 2017, 373 patients were screened and 132 patients were randomly assigned to the early TIPS group (n=86) or to the control group (n=46). After exclusion of three individuals subsequently found to be ineligible for enrolment (two patients in the early TIPS group with non-cirrhotic portal hypertension or hepatocellular carcinoma, and one patient in the control group due to non-cirrhotic portal hypertension), 84 patients in the early TIPS group and 45 patients in the control group were included in the intention-to-treat population. 15 (18%) patients in the early TIPS group and 15 (33%) in the control group died; two (2%) patients in the early TIPS group and one (2%) in the control group underwent liver transplantation. Transplantation-free survival was higher in the early TIPS group than in the control group (hazard ratio 0.50, 95% CI 0.25-0.98; p=0.04). Transplantation-free survival at 6 weeks was 99% (95% CI 97-100) in the early TIPS group compared with 84% (75-96; absolute risk difference 15% [95% CI 5-48]; p=0.02) and at 1 year was 86% (79-94) in the early TIPS group versus 73% (62-88) in the control group (absolute risk difference 13% [95% CI 2-28]; p=0.046). There were no significant differences between the two groups in the incidence of hepatic hydrothorax (two [2%] of 84 patients in the early TIPS group vs one [2%] of 45 in the control group; p=0.96), spontaneous bacterial peritonitis (one [1%] vs three [7%]; p=0.12), hepatic encephalopathy (29 [35%] vs 16 [36%]; p=1.00), hepatorenal syndrome (four [5%] vs six [13%]; p=0.10), and hepatocellular carcinoma (four [5%] vs one [2%]; p=0.68). There was no significant difference in the number of patients who experienced other serious adverse events (ten [12%] vs 11 [24%]; p=0.07) or non-serious adverse events (21 [25%] vs 19 [42%]; p=0.05) between groups. INTERPRETATION Early TIPS with covered stents improved transplantation-free survival in selected patients with advanced cirrhosis and acute variceal bleeding and should therefore be preferred to the current standard of care. FUNDING National Natural Science Foundation of China, National Key Technology R&D Program, Optimized Overall Project of Shaanxi Province, Boost Program of Xijing Hospital.
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Application of thromboelastography to evaluate the effect of different routes administration of tranexamic acid on coagulation function in total hip arthroplasty
Xu X, Jiang J, Liu W, Li X, Lu H
Journal of orthopaedic surgery and research. 2019;14(1):430
Abstract
BACKGROUND Tranexamic acid (TXA) is widely used to reduce blood loss and transfusion rates in total hip arthroplasty(THA). Thromboelastography, which can monitor coagulation changes from clotting to fibrinolysis dynamically. In this study, thromboelastography was used to assess the dynamic changes in the coagulation of patients who underwent THA with the administration of TXA. METHODS This randomized controlled trial consisted of 207 consecutive patients who underwent primary total hip arthroplasty. Patients were randomized into three groups: topical-TXA group received a topical application of TXA, IV-TXA group received an intravenous injection of TXA, and control group. Thromboelastography was performed 1 day before surgery and first, fourth, seventh days after surgery. The primary outcomes were thromboelastography parameters, the rates of deep vein thrombosis(DVT), and pulmonary embolism(PE). Secondary outcomes included perioperative blood loss, transfusion rates, and other perioperative complications. RESULTS The mean calculated total blood loss in the Topical-TXA group were 832.7 +/- 279.84 ml and 834.8 +/- 322.94 ml in the IV-TXA group, which were significantly reduced (p < 0.05) compared with control groups at 1093.3 +/- 379.7 ml. There were no significant differences between topical-TXA and IV-TXA groups in total blood loss or transfusion rates. K and R have reached a nadir from preoperative levels to 4th day postoperatively and then began to increase.alpha angle and CI peaked from preoperative levels to the fourth day postoperatively and then began to decline.IV-TXA significantly (p < 0.05) promoted coagulation levels compared with topical-TXA and control groups in the early postoperative period. Almost no significant differences were observed between topical-TXA and control groups in thromboelastography parameters.No significant differences were observed in the incidence of thromboembolic complications and other perioperative complications. CONCLUSIONS The topical administration of TXA had the same hemostatic effect as intravenous injection tranexamic acid. Coagulation function peaked on 4th day postoperatively and then began to decline. IV-TXA was more enhanced coagulation functions compared with topical-TXA.