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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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A randomised non-inferiority trial comparing the effectiveness of oral versus intravenous tranexamic acid in primary total hip and knee arthroplasty
DeFrancesco CJ, Reichel JF, Gbaje E, Popovic M, Freeman C, Wong M, DeMeo D, Liu J, Gonzalez Della Valle A, Ranawat A, et al
British journal of anaesthesia. 2022
Abstract
BACKGROUND Tranexamic acid (TXA) reduces rates of blood transfusion for total hip arthroplasty (THA) and total knee arthroplasty (TKA). Although the use of oral TXA rather than intravenous (i.v.) TXA might improve safety and reduce cost, it is not clear whether oral administration is as effective. METHODS This noninferiority trial randomly assigned consecutive patients undergoing primary THA or TKA under neuraxial anaesthesia to either one preoperative dose of oral TXA or one preoperative dose of i.v. TXA. The primary outcome was calculated blood loss on postoperative day 1. Secondary outcomes were transfusions and complications within 30 days of surgery. RESULTS Four hundred participants were randomised (200 THA and 200 TKA). The final analysis included 196 THA patients (98 oral, 98 i.v.) and 191 TKA patients (93 oral, 98 i.v.). Oral TXA was non-inferior to i.v. TXA in terms of calculated blood loss for both THA (effect size=-18.2 ml; 95% confidence interval [CI], -113 to 76.3; P<0.001) and TKA (effect size=-79.7 ml; 95% CI, -178.9 to 19.6; P<0.001). One patient in the i.v. TXA group received a postoperative transfusion. Complication rates were similar between the two groups (5/191 [2.6%] oral vs 5/196 [2.6%] i.v.; P=1.00). CONCLUSIONS Oral TXA can be administered in the preoperative setting before THA or TKA and performs similarly to i.v. TXA with respect to blood loss and transfusion rates. Switching from i.v. to oral TXA in this setting has the potential to improve patient safety and decrease costs.
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Effect of Mirena Intrauterine Device on Endometrial Thickness, Quality of Life Score, and Curative Effect in Patients with Perimenopausal Abnormal Uterine Bleeding
Yu Y, Zhou Z, Wang L, Liu J
Computational and mathematical methods in medicine. 2022;2022:5648918
Abstract
OBJECTIVE To study the effect of Mirena intrauterine device (IUD) on endometrial thickness, life quality score, and curative effect in patients with perimenopausal abnormal uterine bleeding. METHODS Eighty patients with perimenopausal abnormal uterine bleeding cured from January 2020 to December 2021 were enrolled as the object of study. According to random number table, the patients were classified into the study (n = 40) and control (n = 40) groups. The control cases were cured with medroxyprogesterone. The study cases were cured with Mirena IUD. The effective rate of clinical therapies was evaluated after 3 months of treatment. The endometrial thickness, menstrual volume score, and life quality score (WHOQOL-BREF) was measured after 1 month, 2 months, and 3 months of treatment. RESULTS The effective rate of patients with Mirena IUD for 3 months was higher compared to the control group (P < 0.05). The endometrial thickness and menstrual volume scores of study cohort after 1 month, 2 months, and 3 months following treatment were remarkably lower than those before treatment (P < 0.05) and were considerably lower than those of control cohort (P < 0.05). The hemoglobin level of the studied cases after 1 month, 2 months, and 3 months after therapy was remarkably upregulated (P < 0.05) and was greatly higher compared to the controlled cases (P < 0.05). After 3-month treatment, the WHOQOL-BREF score of the study group was higher compared to the control group (P < 0.05). CONCLUSION The Mirena IUD is far more effective in the treatment of perimenopausal abnormal uterine bleeding and is helpful in reducing the thickness of the endometrium. Patients' menstrual flow can be controlled, and anemia can be corrected; thus, patients improve their quality of life and health status and can be considered for further promotion.
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Primary nursing intervention can improve the prognosis and postoperative quality of life of patients with hypertensive intracerebral hemorrhage undergoing minimally invasive surgery
Wu L, Liu J, Lai J, Meng L
American journal of translational research. 2021;13(4):2955-2961
Abstract
OBJECTIVE This study aimed to explore the role of primary nursing in patients with hypertensive intracerebral hemorrhage (HICH) undergoing minimally invasive surgery. METHODS We randomly assigned 106 patients with HICH treated in our hospital to receive routine nursing (54 cases, group A) or primary nursing in addition to routine nursing (52 cases, group B). The scores of negative emotions, incidence of complications, quality of life, and prognosis of all patients were recorded. RESULTS The score of negative emotions and the incidence of complications were lower in group B than in group A (P < 0.05). The scores of quality of life and prognosis were higher in group B than in group A (P < 0.05). CONCLUSION Primary nursing intervention can improve the prognosis and postoperative quality of life of patients with HICH undergoing minimally invasive surgery.
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Preemptive antifibrinolysis: its role and efficacy in hip-fracture patients undergoing total hip arthroplasty
Liu J, Lei Y, Liao J, Liang X, Hu N, Huang W
The Journal of arthroplasty. 2021
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Editor's Choice
Abstract
BACKGROUND We aimed to determine the efficacy of preemptive antifibrinolysis with tranexamic acid (TXA) in decreasing hidden blood loss (HBL) in the elderly hip fracture patients. METHODS 96 elderly hip fracture patients receiving hip arthroplasty were randomized to receive 100 ml of normal-saline (Group A) or 1.5 g of TXA (Group B) intravenously q12h from post-admission day 1 (PAD1) to the day before surgery. Both groups were treated with 1.5 g of TXA q12h from postoperative day 1 (POD1) to POD3. HBL was calculated by formulas and recorded as the primary outcome. RESULTS In overall analyses, no difference was found in HBL, while the decline-of-hemoglobin (ΔHb), allogeneic-blood-transfusion (ABT) rate, fibrinogen-degradation-product (FDP, on PAD2, PAD3, POD1 and POD2) and D-dimer (D-D, on PAD2, PAD3 and POD1) were lower in Group B. In subgroup analyses for patients receiving intervention within 72 hours of injury, Group B had lower postoperative HBL, ΔHb, ABT rate, FDP and D-D levels (on PAD2, PAD3, POD1 and POD2). For patients receiving intervention over 72 hours after injury, no difference was detected in perioperative HBL, ΔHb, ABT rate between the two groups. The FDP and D-D levels were lower in Group B on PAD2 and PAD3. No difference was found in coagulation parameters, wound complications, VTE rate and 90-day mortality in all analyses. CONCLUSION Early administration (within 72 hours of injury) of multi-dose of TXA is effective in reducing perioperative HBL in elderly hip fracture patients. Delayed use (over 72 hours after injury) of TXA was not beneficial.
PICO Summary
Population
Elderly hip fracture patients undergoing total hip arthroplasty (n= 96).
Intervention
Intravenous tranexamic acid (TXA) every 12 hours from post-admission day to the day before surgery (n= 48).
Comparison
Normal saline (n= 48).
Outcome
No difference was found in hidden blood loss, while the decline-of-haemoglobin (ΔHb), allogeneic-blood-transfusion (ABT) rate, fibrinogen-degradation-product and D-dimer were lower in patients receiving TXA. For patients receiving intervention over 72 hours after injury, no difference was detected in perioperative hidden blood loss, ΔHb, ABT rate between the two groups. No difference was found in coagulation parameters, wound complications, venous thromboembolism rate and 90-day mortality.
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Safety and efficacy of thalidomide in patients with transfusion-dependent β-thalassemia: a randomized clinical trial
Chen JM, Zhu WJ, Liu J, Wang GZ, Chen XQ, Tan Y, Xu WW, Qu LW, Li JY, Yang HJ, et al
Signal transduction and targeted therapy. 2021;6(1):405
Abstract
Thalidomide induces γ-globin expression in erythroid progenitor cells, but its efficacy on patients with transfusion-dependent β-thalassemia (TDT) remains unclear. In this phase 2, multi-center, randomized, double-blind clinical trial, we aimed to determine the safety and efficacy of thalidomide in TDT patients. A hundred patients of 14 years or older were randomly assigned to receive placebo or thalidomide for 12 weeks, followed by an extension phase of at least 36 weeks. The primary endpoint was the change of hemoglobin (Hb) level in the patients. The secondary endpoints included the red blood cell (RBC) units transfused and adverse effects. In the placebo-controlled period, Hb concentrations in patients treated with thalidomide achieved a median elevation of 14.0 (range, 2.5 to 37.5) g/L, whereas Hb in patients treated with placebo did not significantly change. Within the 12 weeks, the mean RBC transfusion volume for patients treated with thalidomide and placebo was 5.4 ± 5.0 U and 10.3 ± 6.4 U, respectively (P < 0.001). Adverse events of drowsiness, dizziness, fatigue, pyrexia, sore throat, and rash were more common with thalidomide than placebo. In the extension phase, treatment with thalidomide for 24 weeks resulted in a sustainable increase in Hb concentrations which reached 104.9 ± 19.0 g/L, without blood transfusion. Significant increase in Hb concentration and reduction in RBC transfusions were associated with non β0/β0 and HBS1L-MYB (rs9399137 C/T, C/C; rs4895441 A/G, G/G) genotypes. These results demonstrated that thalidomide is effective in patients with TDT.
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A multicenter, randomized phase III trial of hetrombopag: a novel thrombopoietin receptor agonist for the treatment of immune thrombocytopenia
Mei H, Liu X, Li Y, Zhou H, Feng Y, Gao G, Cheng P, Huang R, Yang L, Hu J, et al
Journal of hematology & oncology. 2021;14(1):37
Abstract
BACKGROUND Hetrombopag, a novel thrombopoietin receptor agonist, has been found in phase I studies to increase platelet counts and reduce bleeding risks in adults with immune thrombocytopenia (ITP). This phase III study aimed to evaluate the efficacy and safety of hetrombopag in ITP patients. METHODS Patients who had not responded to or had relapsed after previous treatment were treated with an initial dosage of once-daily 2.5 or 5 mg hetrombopag (defined as the HETROM-2.5 or HETROM-5 group) or with matching placebo in a randomized, double-blind, 10-week treatment period. Patients who received placebo and completed 10 weeks of treatment switched to receive eltrombopag, and patients treated with hetrombopag in the double-blind period continued hetrombopag during the following open-label 14-week treatment. The primary endpoint was the proportion of responders (defined as those achieving a platelet count of ≥ 50 × 10(9)/L) after 8 weeks of treatment. RESULTS The primary endpoint was achieved by significantly more patients in the HETROM-2.5 (58.9%; odds ratio [OR] 25.97, 95% confidence interval [CI] 9.83-68.63; p < 0.0001) and HETROM-5 (64.3%; OR 32.81, 95% CI 12.39-86.87; p < 0.0001) group than in the Placebo group (5.9%). Hetrombopag was also superior to placebo in achieving a platelet response and in reducing the bleeding risk and use of rescue therapy throughout 8 weeks of treatment. The durable platelet response to hetrombopag was maintained throughout 24 weeks. The most common adverse events were upper respiratory tract infection (42.2%), urinary tract infection (17.1%), immune thrombocytopenic purpura (17.1%) and hematuria (15%) with 24-week hetrombopag treatment. CONCLUSIONS In ITP patients, hetrombopag is efficacious and well tolerated with a manageable safety profile. Trial registration Clinical trials.gov NCT03222843 , registered July 19, 2017, retrospectively registered.
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Application of Perioperative Transfusion Trigger Score in Patients Undergoing Surgical Treatment of Malignant Tumor
Zhang F, Zheng ZB, Zhu ZQ, Liu DX, Liu J
Indian J Hematol Blood Transfus. 2020;36(1):156-163
Abstract
The present study aimed to investigate the clinical effects of the brand new perioperative transfusion trigger score (POTTS) system in patients undergoing malignant tumor surgeries. 442 cases of patients diagnosed with malignant tumor were randomly selected (from January 2012 to December 2016) from Zunyi Medical University and were divided into 3 experimental groups. Patients in the POTTS group were transfused by the POTTS guideline perioperatively, while patients in the 7-10 g group were treated by the traditional transfusion guidelines existed (restrictive transfusion strategy), patients in the 10 g group should be transfused to keep the Hb level no less than 10 g/dL (liberal transfusion strategy). Baseline information, operation time, bleeding volume, transfusion amount, incision healing time, postoperative complications, metastasis and recurrence were observed and recorded. Postoperative short-term mortality was comparable of the 3 groups, 3 cases of death all occurred in 10 g group, there was no significant difference in the incidence of postoperative complications, including infectious complications and coagulation related complications. Follow-up to date, there were 25 cases, 29 cases and 29 cases of tumor recurrence and metastasis in the three groups, but no statistical difference observed. The present findings show that the POTTS transfusion system is more advantageous with regard to save blood and relieve economic burdens of patients, and does not affect the long-term recurrence and metastasis rate of malignant tumor.
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Tranexamic acid is beneficial for blood management of high tibial osteotomy: a randomized controlled study
Ni J, Liu J, Zhang J, Jiang J, Dang X, Shi Z
Arch Orthop Trauma Surg. 2020
Abstract
INTRODUCTION The purpose of this study was to investigate whether TXA can effectively reduce blood loss after HTO and related complications and to evaluate its safety. MATERIALS AND METHODS From March 2016 to March 2018, 100 patients who underwent medial opening wedge HTO in the Department of Orthopedics, the second affiliated hospital of xi'an jiaotong university, with an average age of 52.8 ± 3.2 years, were randomly divided into the TXA group (using intravenous TXA) and the control group (using the same amount of normal saline), with 50 patients in each group. The postoperative wound drainage volume, decrease in hemoglobin and hematocrit value, total blood loss, wound healing, blood transfusion, deep venous thrombosis (DVT) and pulmonary embolism (PE) were compared between the two groups. RESULTS The drainage volume on the first postoperative day and the total drainage volume of the TXA group were significantly lower compared with those of the control group (145.7 vs 264.5 ml, 282.3 vs 413.2 ml, P < 0.05). The decreases in the hemoglobin and hematocrit values on the postoperative first, second and fifth days were lower in the TXA group than those in the control group (1.4 VS 3.5, 2.6 vs 3.3, 1.9 vs 2.9 g, P < 0.05; 3.3 vs 5.5, 5.0 vs 9.1, 3.8 vs 7.2%, P < 0.05), and the mean total blood loss was also lower in the TXA group than that in the control group (477.9 vs 834.6 ml, P < 0.05). In the control group, 1 patient had wound hematoma requiring additional paracentesis and pressure dressing, 1 patient had superficial wound infection requiring additional debridement, and 1 patient had postoperative blood transfusion compared to none in the TXA group (P > 0.05). There was no symptomatic DVT or PE in either of the groups. CONCLUSION Intravenous TXA can effectively and safely reduce blood loss and bleeding-related complications after HTO and was beneficial for the blood management of HTO.
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Effects of dual plasma molecular adsorption system on liver function, electrolytes, inflammation, and immunity in patients with chronic severe hepatitis
Chen G, Wu M, Wu B, Liu F, Liu J, Liu L
Journal of clinical laboratory analysis. 2019;:e22926
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Abstract
BACKGROUND To investigate the effects of dual plasma molecular adsorption system (DPMAS) on the liver function, electrolytes, inflammation, and immunity in patients with chronic severe hepatitis (CSH). METHODS Total of 162 patients with CSH treated in our hospital from March 2016 to December 2018 were enrolled and equally randomly divided into control group (n = 81) and observation group (n = 81). The patients in control group were treated with plasma exchange, while those in observation group were additionally treated with DPMAS based on the treatment in control group. The liver function, electrolytes, inflammation, and immunity were evaluated and compared between the two groups. RESULTS After treatment, the liver function indexes in observation group were significantly favorable compared with those in control group, with the reduction in TBIL, DBIL, ALT, and rise of CHE levels (P < 0.05). The levels of K(+) , Na(+) , Cl(-) , and Ca(2+) in both groups were significantly improved after treatment (P < 0.05), although there were no significant differences between the two groups (P > 0.05). The levels of C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha) in both groups declined after treatment compared with those before treatment, and those levels in observation group were higher than that in control group (P < 0.05). After treatment, the levels of cluster of differentiation 3(+) (CD3(+) ), CD4(+) , and CD4(+) /CD8(+) were higher in observation group than those in control group, with decreasing level of CD8(+) (P < 0.05). CONCLUSION Dual plasma molecular adsorption system can effectively improve the liver function, effectively correct the electrolyte disorders, reduce the inflammatory response, and adjust the immunity in patients with CSH.