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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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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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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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Intra-articular platelet-rich plasma combined with hyaluronic acid injection for knee osteoarthritis is superior to PRP or HA alone in inhibiting inflammation and improving pain and function
Xu Z, He Z, Shu L, Li X, Ma M, Ye C
Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association. 2020
Abstract
PURPOSE The goal of this study was to evaluate the effectiveness and explore the therapeutic mechanisms of PRP combined with HA as a treatment for knee osteoarthritis (KOA). METHODS In total, 122 knees were randomly divided into HA (34 knees), PRP (40 knees), and PRP+HA (48 knees) groups. Platelet densities in whole blood and PRP were examined using Wright-Giemsa staining. Visual Analogue Scale (VAS), Lequesne, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lysholm scores and postoperative complications were evaluated. High-frequency color Doppler imaging was used to observe the synovium and cartilage. Enzyme-linked immunosorbent assays (ELISAs) were used to quantify interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), matrix metalloproteinase-3 (MMP-3), and tissue inhibitor of metalloproteinase-1 (TIMP-1) levels in synovial fluid. RESULTS The platelet density in PRP was 5.13-times that in whole blood (P = .002). At 24 months, pain and function scores in the PRP+HA group were better than those in the HA and PRP alone groups (P(pain) = .000; P(function) = .000). At 6 and 12 months, synovial hyperplasia in the PRP and PRP+HA groups was improved (P < .05). After 6 and 12 months, the synovial peak systolic velocity (PSV), synovial end diastolic velocity (EDV), systolic/diastolic ratio (S/D) and resistance index (RI) were improved in the PRP+HA group (P < .05). Complications were highest in the PRP group (P = .008). After 6 and 12 months, IL-1β, TNF-α, MMP-3, and TIMP-1 in the PRP and PRP+HA groups decreased (P < .05), with more apparent inhibition in the PRP+HA group (P < .05). CONCLUSIONS PRP combined with HA is more effective than PRP or HA alone at inhibiting synovial inflammation and can effectively improve pain and function and reduce adverse reactions. Its mechanism involves changes in the synovium and cytokine content.
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Intraoperative cell salvage for obstetrics: a prospective randomized controlled clinical trial
Liu Y, Li X, Che X, Zhao G, Xu M
BMC pregnancy and childbirth. 2020;20(1):452
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Editor's Choice
Abstract
BACKGROUND The latest basic studies and clinical evidence have confirmed the safety and efficacy of intraoperative autologous blood cell transfusion in cardiac surgery and orthopaedics. However, in caesarean section, there are still concerns about the contamination of amniotic fluid and foetal components, and consequently the application of intraoperative autologous blood cell transfusion is not universal. Therefore, this study aimed to evaluate the clinical value of intraoperative autologous blood cell transfusion in obstetric surgery. METHODS A prospective, randomized, controlled, feasibility study was performed in women undergoing caesarean section. One hundred sixteen participants were randomly assigned at a 1:1 ratio into either the intraoperative cell salvage group or the control group. Allogeneic blood cells were transfused into patients with haemoglobin concentrations < 80 g/dL in both the intraoperative cell salvage group and the control group. RESULTS No significant differences were found between the two groups in age, weight, maternal parity, history of previous caesarean section, gestational weeks of delivery, etc. However, compared with the control group, patients in the intraoperative cell salvage group had a significantly lower amount of allogeneic blood cell transfusion, lower incidence of postoperative incision infection, delayed wound healing, perioperative allergy, adverse cardiovascular events, hypoproteinaemia and shorter hospital stay. CONCLUSION The results of this study suggest that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage. TRIAL REGISTRATION All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional and/or National Research Committee of Beijing Obstetrics and Gynecology Hospital, Capital Medical University (2016-XJS-003-01) as well as the 1964 Helsinki Declaration and its later amendments or other comparable ethical standards. The clinical trials were registered (ChiCTR-ICC-15,007,096) on September 28, 2015.
PICO Summary
Population
Women undergoing caesarean section (n= 116).
Intervention
Intraoperative cell salvage (n= 58).
Comparison
Control group, allogeneic red blood cell infusion when the haemoglobin concentration was < 80 g/L (n= 58).
Outcome
Patients in the intraoperative cell salvage group had a significantly lower amount of allogeneic blood cell transfusion, lower incidence of postoperative incision infection, delayed wound healing, perioperative allergy, adverse cardiovascular events, hypoproteinaemia and shorter hospital stay.
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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.
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Roxadustat Treatment for Anemia in Patients Undergoing Long-Term Dialysis
Chen N, Hao C, Liu BC, Lin H, Wang C, Xing C, Liang X, Jiang G, Liu Z, Li X, et al
The New England journal of medicine. 2019
Abstract
BACKGROUND Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates iron metabolism. Additional data are needed regarding the effectiveness and safety of roxadustat as compared with standard therapy (epoetin alfa) for the treatment of anemia in patients undergoing dialysis. METHODS In a trial conducted in China, we randomly assigned (in a 2:1 ratio) patients who had been undergoing dialysis and erythropoiesis-stimulating agent therapy with epoetin alfa for at least 6 weeks to receive roxadustat or epoetin alfa three times per week for 26 weeks. Parenteral iron was withheld except as rescue therapy. The primary end point was the mean change in hemoglobin level from baseline to the average level during weeks 23 through 27. Noninferiority of roxadustat would be established if the lower boundary of the two-sided 95% confidence interval for the difference between the values in the roxadustat group and epoetin alfa group was greater than or equal to -1.0 g per deciliter. Patients in each group had doses adjusted to reach a hemoglobin level of 10.0 to 12.0 g per deciliter. Safety was assessed by analysis of adverse events and clinical laboratory values. RESULTS A total of 305 patients underwent randomization (204 in the roxadustat group and 101 in the epoetin alfa group), and 256 patients (162 and 94, respectively) completed the 26-week treatment period. The mean baseline hemoglobin level was 10.4 g per deciliter. Roxadustat led to a numerically greater mean (+/-SD) change in hemoglobin level from baseline to weeks 23 through 27 (0.7+/-1.1 g per deciliter) than epoetin alfa (0.5+/-1.0 g per deciliter) and was statistically noninferior (difference, 0.2+/-1.2 g per deciliter; 95% confidence interval [CI], -0.02 to 0.5). As compared with epoetin alfa, roxadustat increased the transferrin level (difference, 0.43 g per liter; 95% CI, 0.32 to 0.53), maintained the serum iron level (difference, 25 mug per deciliter; 95% CI, 17 to 33), and attenuated decreases in the transferrin saturation (difference, 4.2 percentage points; 95% CI, 1.5 to 6.9). At week 27, the decrease in total cholesterol was greater with roxadustat than with epoetin alfa (difference, -22 mg per deciliter; 95% CI, -29 to -16), as was the decrease in low-density lipoprotein cholesterol (difference, -18 mg per deciliter; 95% CI, -23 to -13). Roxadustat was associated with a mean reduction in hepcidin of 30.2 ng per milliliter (95% CI, -64.8 to -13.6), as compared with 2.3 ng per milliliter (95% CI, -51.6 to 6.2) in the epoetin alfa group. Hyperkalemia and upper respiratory infection occurred at a higher frequency in the roxadustat group, and hypertension occurred at a higher frequency in the epoetin alfa group. CONCLUSIONS Oral roxadustat was noninferior to parenteral epoetin alfa as therapy for anemia in Chinese patients undergoing dialysis. (Funded by FibroGen and FibroGen [China] Medical Technology Development; ClinicalTrials.gov number, NCT02652806.).
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Influence of perioperative leukodeplated red blood cell transfusion on immune function of patients with bladder cancer
Shi J, Gao B, Yang Y, Yang L, Li X
Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi = Chinese Journal of Cellular and Molecular Immunology. 2018;34((7)):632-636.
Abstract
Objective To investigate the effect of leukodeplated red blood cell (RBC) transfusion on immune function of patients with bladder cancer. Methods A total of 48 patients with bladder cancer who required perioperative RBC transfusion were randomized into two groups: 22 received leukodeplated RBC transfusion (Group I) and 26 received suspended RBC transfusion (Group II ). T-cell subgroup, natural killer cell activity, erythrocyte-C3b receptor rosette formation rate, and immunosuppressive acidic protein (IAP) level were determined for the two groups before and after transfusion, and the results were statistically analyzed. Results There was no obvious difference in immune function between the two groups before transfusion. After transfusion, the immune function of both groups was lower. However, it was higher in Group I than in Group II . IAP level was higher after transfusion than before transfusion; however, it was lower in Group I than in Group II . Conclusion Perioperative RBC transfusion can decrease immune function in patients with bladder cancer. Compared with suspended RBC transfusion, leukodeplated RBC transfusion can improve immune function in patients with bladder cancer.