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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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Serum Levels of VWF, t-PA, TNF-α, and ICAM-1 in Patients Receiving Hemocoagulase Combined with Platelet-Rich Plasma during Total Hip Replacement
Huang Y, Zhou B, Zhang D, Chen Y
Genetics research. 2022;2022:2766215
Abstract
OBJECTIVES This study aimed to investigate the effect of hemocoagulase combined with platelet-rich plasma (PRP) in total hip replacement (THR) on reducing bleeding and improving knee joint function in the patients with osteoarthritis. METHODS From February 2018 to February 2020, 80 osteoarthritis patients undergoing THR were included in the study, of which 40 cases were treated with PRP and hemocoagulase (test group) in the joint capsule in THR and the other 40 cases received saline and thrombin in the joint capsule after THR (control group). Postoperative drainage and corresponding functional exercise were performed for the two groups 12 hours after operation. The outcome measures including operation time, soft-tissue release, blood routine, drainage volume, perioperative blood loss, postoperative incision inflammation, deep vein thrombosis (DVT), and range of motion (ROM) of the joint were recorded. RESULTS The hemoglobin and hematocrit values of the test group on the second postoperative day were significantly higher than those of the control group (P < 0.05). The postoperative drainage volume and perioperative blood loss were significantly lower than those of the control group (P < 0.05). The test group was better than the control group in the ROM of the joint at 7 and 15 days after the operation (P < 0.05). A lower value of prothrombin time and activated partial thromboplastin time was revealed in the test group compared with the control group (P < 0.05). No significant difference in the operation time, intraoperative soft-tissue release, postoperative incision inflammation, incidence of DVT, incidence of deep infection, and ROM at day 90 after THR was found in the two groups (P > 0.05). CONCLUSIONS The application of hemocoagulase combined with PRP in THR can reduce perioperative blood loss, increase wound healing speed and quality, and improve coagulation and immune function. It is a safe and effective method for the patients with knee osteoarthritis who underwent THR.
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Efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection for the treatment of renal anemia in Chinese hemodialysis patients: A randomized, open-label, parallel-group, noninferiority phase III trial
Liu B, Chen N, Zhao J, Yin A, Wu X, Xing C, Jiang G, Fu J, Wang M, Wang R, et al
Chronic diseases and translational medicine. 2022;8(2):134-144
Abstract
BACKGROUND This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection (recombinant human erythropoietin injection, rHuEPO) for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis. METHOD This study was a multicenter, randomized, open-label, intergroup parallel control phase III noninferiority trial from April 19, 2013 to September 9, 2014 at 25 sites. In this study, the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks. The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week. All subjects underwent epoetin alfa administration during the 8-week baseline period. After that, subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group. The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period (noninferiority threshold: -1.0 g/dl) was tested between the two treatments. The time-dependent hemoglobin (Hb) concentration and the maintenance rate of the target Hb concentration (the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl) were also evaluated. Iron metabolism, including changes in the serum iron, total iron-binding capacity, ferritin, transferrin saturation, and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further. Adverse events (AEs) were also observed and compared, and the safety was analyzed between the two treatment groups. The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed. SAS® software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. RESULTS Four hundred and sixty-six patients were enrolled in this study, and ultimately 384 cases were analyzed for safety, including 267 cases in the darbepoetin alfa group and 117 cases in the epoetin alfa group. There were 211 cases in the per-protocol set, including 152 cases in the darbepoetin alfa group and 59 cases in the epoetin alfa group. The changes in the average Hb concentrations from the baseline to the end of the evaluation period were -0.07 and -0.15 g/dl in the darbepoetin alfa group and epoetin alfa group respectively. The difference between the two groups was 0.08 g/dl (95% confidence interval [CI]: -0.22 to 0.39), and the lower limit of the 95% CI was -0.22 > -1.0 g/dl. The average Hb concentrations of the two groups were 10.88-11.43 g/dl (darbepoetin alfa) and 10.91-11.38 g/dl (epoetin alfa) during the study period of Weeks 0-28, with the maintenance rates of the target Hb concentration ranging within 71%-87% and 78%-95% in the darbepoetin alfa group and epoetin alfa group respectively. During the period of comparison between the two groups, the incidence of AEs in the darbepoetin alfa group was 61.42%, while in the epoetin alfa group it was 56.41%. All of the adverse events and reactions in the study were those commonly associated with hemodialysis. CONCLUSION The overall efficacy and safety of darbepoetin alfa for the treatment of Chinese renal anemia patients undergoing hemodialysis are consistent with those of epoetin alfa.
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Darbepoetin alfa injection versus epoetin alfa injection for treating anemia of Chinese hemodialysis patients with chronic kidney failure: A randomized, open-label, parallel-group, non-inferiority Phase III trail
Chen N, Xing C, Niu J, Liu B, Fu J, Zhao J, Ni Z, Wang M, Liu W, Zhao J, et al
Chronic diseases and translational medicine. 2022;8(1):59-70
Abstract
BACKGROUND Erythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0-12.0 g/dL) for the treatment of renal anemia. METHODS Ninety-five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients (n = 95) aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group (n = 56) and a twice or three times per week intravenous epoetin alfa group (n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA-naive (erythropoiesis stimulating agent-naive). The primary efficacy profile was the mean Hb level (the non-inferiority margin was -1.0 g/dL, week 21-28); the secondary efficacy profiles were the Hb increase rate (week 0-4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS® software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. RESULTS The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>-1.0 g/dL), and non-inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis. CONCLUSION Darbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.
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An alternative method for personalized tourniquet pressure in total knee arthroplasty: a prospective randomized and controlled study
Wu J, Fu Q, Li H, Han Y, Deng J, Chen Y, Qian Q
Scientific reports. 2022;12(1):9652
Abstract
Tourniquet use always carries potential risks, which can range from mild transient functional impairments of thigh pain, skin blisters to severe permanent dysfunction of limb paralysis, nerve injuries or compartment syndrome. The ideal method for minimizing intraoperative tourniquet pressure (TP) for reducing postoperative complications remains controversial. In this prospective, randomized and controlled study, we reinvestigated an estimation formula for TP based on thigh circumferences and systolic blood pressure (SBP) with two traditional methods for TP determination in total knee arthroplasty (TKA): SBP plus 100 mmHg and a fixed value of 300 mmHg. TP values and postoperative thigh pain scores were compared among three groups. The intraoperative TP value of the formula-calculated group was lower than that of the traditional groups (14.7 mmHg, P = 0.3475 and 94.7 mmHg, P < 0.0001, respectively), while no differences of hemostatic effect at the surgical fields and wound complications were detected among groups. The thigh pain scores at the tourniquet site decreased gradually over time and the estimation group had the lowest scores at each timepoint after surgery. Estimation method for TP was easy and rapid, without relying on specific equipment. It could provide a practical low TP and comparable hemostatic effect in TKA using an inflating tourniquet.
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Application of hepatitis B immunoglobulin in prevention of mother-to-child transmission of chronic hepatitis B in HBsAg- and HBeAg-positive mother
Luo Q, Wang H, Fang JW, Gu ZW, Song DJ, Chen Y, Chen GD, Zhao B, Sun C, Ma Y, et al
Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology. 2021;:1-6
Abstract
The aim of our study was to compare the efficacy of two dosages of hepatitis B immunoglobulin (HBIG) combined with HBV vaccine (HBVac) to prevent mother-to-child transmission (MTCT) of hepatitis B in HBsAg- and HBeAg-positive mother. We enrolled 331 mother-infant pairs with HBsAg- and HBeAg-positive maternal state from the Women's Hospital School of Medicine of Zhejiang University. Newborns were randomly distributed into two groups according to the dosages of HBIG injection: 100 IU and 200 IU. Newborns from both groups were injected with HBVac in the same doses. We compared the immune outcomes between the two groups and explore the influencing factors of immune outcomes through regression analysis. There was no statistically significant relationship between HBsAg serological transmission of newborns and dosages of HBIG in HBsAg- and HBeAg-positive mother (p > .05). The Logistic regression showed that high DNA load is a risk factor for passive-active immunoprophylaxis failure for both 100 IU and 200 IU group, but higher-dosage HBIG is not necessary for higher-viral-load pregnant women with HBsAg- and HBeAg-positive. In conclusion, combined application of HBVac and a single dose of 100 IU HBIG can achieve the ideal MTCT interruption results for HBsAg- and HBeAg-positive pregnant women.IMPACT STATEMENTWhat is already known on this subject? Passive-active immunoprophylaxis is proved to be effective in preventing mother-to-child transmission of hepatitis B. Hepatitis B vaccine combined with 100 IU or 200 IU immunoglobulin is mostly recommended in China.What do the results of this study add? At present, there is still a lack scientific basis for improving existing strategies and measures to prevent mother-to-child transmission of hepatitis B in China.What are the implications of these findings for clinical practice and/or further research? 100 IU and 200 IU immunoglobulin show equivalent blocking effect, and combined use of hepatitis B vaccine and 100 IU immunoglobulin is more cost-effective.
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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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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.
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Regular bleeding risk assessment associated with reduction in bleeding outcomes: The mAFA II randomised trial
Guo Y, Lane DA, Chen Y, Lip GYH
Am J Med. 2020
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Abstract
BACKGROUND The mobile Atrial fibrillation application (mAFA-II) randomised trial reported that a holistic management strategy supported by mobile Health reduced atrial fibrillation-related adverse outcomes. The present study aimed to assess whether regular reassessment of bleeding risk using the HAS-BLED score would improve bleeding outcomes and anticoagulant (OAC) uptake. METHODS Bleeding risk (HAS-BLED score) was monitored prospectively using mAFA, and calculated as 30 days, Days 31-60, Days 61-180, and Days 181-365. Clinical events and OAC changes in relation to the dynamic monitoring were analysed. RESULTS We studied 1793 patients with atrial fibrillation (mean, standard deviation, age 64, 24 years, 32.5% female). Comparing baseline and 12 months, the proportion of atrial fibrillation patients with HAS-BLED ≥3 decreased (11.8% vs. 8.5%, p=0.008), with changes in use of concomitant NSAIDs/antiplatelets, renal dysfunction, and labile international normalized ratio contributing to the decreased proportions of patients with HAS-BLED ≥3 (p<0.05). Among 1077 (60%) patients who had four bleeding risk assessments, incident bleeding events decreased significantly from Days 1-30, to Days 181-365 (1.2% to 0.2%, respectively, p<0.001). Total OAC usage increased from 63.4% to 70.2% (ptrend<0.001). Compared to atrial fibrillation patients receiving usual care (n=1136), bleeding events were significantly lower in atrial fibrillaiton patients with dynamic monitoring of their bleeding risk (mAFA vs usual care, 2.1%, 4.3%, p=0.004). (p<0.001). CONCLUSION Dynamic risk monitoring using the HAS-BLED score, together with holistic App-based management using mAFA II reduced bleeding events, addressed modifiable bleeding risks and increased uptake of OACs.
PICO Summary
Population
Patients with atrial fibrillation enrolled in the mAFA-II trial (n=1793).
Intervention
Dynamic risk monitoring on anticoagulant and bleeding events using the HAS-BLED score at four timepoints (n=1077).
Comparison
Usual care (n=1136).
Outcome
Comparing baseline and 12 months, the proportion of atrial fibrillation patients with HAS-BLED >/=3 decreased (11.8% vs. 8.5%), with changes in use of concomitant NSAIDs/antiplatelets, renal dysfunction, and labile international normalized ratio contributing to the decreased proportions of patients with HAS-BLED >/=3. Among 1077 (60%) patients who had four bleeding risk assessments, incident bleeding events decreased significantly from Days 1-30, to Days 181-365 (1.2% to 0.2%, respectively). Total OAC usage increased from 63.4% to 70.2%. Compared to atrial fibrillation patients receiving usual care (n=1136), bleeding events were significantly lower in atrial fibrillation patients with dynamic monitoring of their bleeding risk (mAFA vs usual care, 2.1%, 4.3%).