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1.
Medullary cavity application of tranexamic acid to reduce blood loss in tibial intramedullary nailing procedures-a randomized controlled trial
Xiao C, Gao Z, Yu W, Yao K, Cao Y, Long N, Zhang S, Jiang Y
International orthopaedics. 2023
Abstract
PURPOSE Studies have shown an average postoperative hidden blood loss (HBL) of 473.29 ml and an average Hb loss of 16.71 g/l after intramedullary nailing. Reducing HBL has become a primary consideration for orthopaedic surgeons. METHODS Patients with only tibial stem fractures who visited the study clinic between December 2019 and February 2022 were randomized into two groups using a computer-generated form. Two grams of tranexamic acid (TXA) (20 ml) or 20 ml of saline was injected into the medullary cavity before implantation of the intramedullary nail. On the morning of the surgery, as well as on days one, three and five after surgery, routine blood tests and analyses of CRP and interleukin-6 were completed. The primary outcomes were total blood loss (TBL), HBL, and blood transfusion, in which the TBL and HBL were calculated according to the Gross equation and the Nadler equation. Three months after surgery, the incidence of wound complications and thrombotic events, including deep vein thrombosis and pulmonary embolism, was recorded. RESULTS Ninety-seven patients (47 in the TXA group and 50 in the NS group) were analyzed; the TBL (252.10 ± 10.05 ml) and HBL (202.67 ± 11.86 ml) in the TXA group were significantly lower than the TBL (417.03 ± 14.60 ml) and HBL (373.85 ± 23.70 ml) in the NS group (p < 0.05). At the three month postoperative follow-up, two patients (4.25%) in the TXA group and three patients (6.00%) in the NS group developed deep vein thrombosis, with no significant difference in the incidence of thrombotic complications (p = 0.944). No postoperative deaths or wound complications occurred in either group. CONCLUSIONS The combination of intravenous and topical TXA reduces blood loss after intramedullary nailing of tibial fractures without increasing the incidence of thrombotic events.
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2.
Are The Applications of Tranexamic Acid in Reverse Hybrid Total Knee Arthroplasty (TKA) The Same as Those in Fully Cemented TKA?: A Randomized Controlled Trial
Zhang S, Wang F, Wang C, Chu P, Shi L, Xue Q
Advances in therapy. 2021
Abstract
INTRODUCTION Traditional fully cemented prosthesis for total knee arthroplasty (TKA) has many disadvantages. Current studies have shown that the effects of mixed fixation TKA are the same as or even better than those of fully cemented TKA. We aimed to compare the total blood loss (TBL) in the two fixation types of TKA and the hemostatic effects of different doses of tranexamic acid (TXA) for reverse hybrid TKA. METHODS From September 2018 to November 2020, 233 patients with knee osteoarthritis undergoing unilateral TKA were randomly divided into four groups: groups 1 and 2: fully cemented TKA + intra-articular injection (IAI) of either 1 g TXA (n = 54) or 2 g TXA (n = 60); groups 3 and 4: reverse hybrid TKA + IAI of either 1 g TXA (n = 56) or 2 g TXA (n = 63). All patients were administered intravenous drip of TXA (20 mg/kg) as the basic drug. Perioperative and follow-up data of all patients were compared. RESULTS The TBL in groups 1, 2, and 3 was higher than that in group 4 (P < 0.0001). The TBL in group 1 was significantly less than that in group 3 (P < 0.05). Although there was no significant difference in blood transfusion demand among the four groups (P > 0.05), the number of anemic patients who did not meet the standard of blood transfusion in group 4 decreased significantly (P < 0.0001). There was no significant difference in pain, function or thrombotic complications among all patients. CONCLUSION The TBL in reverse hybrid TKA is larger than in fully cemented TKA. For reverse hybrid TKA, the hemostatic effect of TXA with 2 g of IAI was significantly better than with 1 g. Although this method does not reduce the need for blood transfusion, it can significantly reduce the incidence of postoperative anemia.
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3.
Erythropoietin Improves Poor Outcomes in Preterm Infants with Intraventricular Hemorrhage
Song J, Wang Y, Xu F, Sun H, Zhang X, Xia L, Zhang S, Li K, Peng X, Li B, et al
CNS drugs. 2021
Abstract
BACKGROUND Intraventricular hemorrhage (IVH) is a common complication in preterm infants that has poor outcomes, especially in severe cases, and there are currently no widely accepted effective treatments. Erythropoietin has been shown to be neuroprotective in neonatal brain injury. OBJECTIVE The objective of this study was to evaluate the protective effect of repeated low-dose recombinant human erythropoietin (rhEPO) in preterm infants with IVH. METHODS This was a single-blinded prospective randomized controlled trial. Preterm infants ≤ 32 weeks gestational age who were diagnosed with IVH within 72 h after birth were randomized to receive rhEPO 500 IU/kg or placebo (equivalent volume of saline) every other day for 2 weeks. The primary outcome was death or neurological disability assessed at 18 months of corrected age. RESULTS A total of 316 eligible infants were included in the study, with 157 in the rhEPO group and 159 in the placebo group. Although no significant differences in mortality (p = 0.176) or incidence of neurological disability (p = 0.055) separately at 18 months of corrected age were seen between the rhEPO and placebo groups, significantly fewer infants had poor outcomes (death and neurological disability) in the rhEPO group: 14.9 vs. 26.4%; odds ratio (OR) 0.398; 95% confidence interval (CI) 0.199-0.796; p = 0.009. In addition, the incidence of Mental Development Index scores of < 70 was lower in the rhEPO group than in the placebo group: 7.2 vs. 15.3%; OR 0.326; 95% CI 0.122-0.875; p = 0.026. CONCLUSIONS Treatment with repeated low-dose rhEPO improved outcomes in preterm infants with IVH. TRIAL REGISTRATION The study was retrospectively registered on ClinicalTrials.gov on 16 April 2019 (NCT03914690).
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Recombinant human thrombopoietin prior to mobilization chemotherapy facilitates platelet recovery in autologous transplantation in patients with lymphoma: Results of a prospective randomized study
Mo H, Liu P, Qin Y, He X, Han X, Yao J, Su W, Zhang S, Tang L, Zhao F, et al
Chronic diseases and translational medicine. 2021;7(3):190-198
Abstract
BACKGROUND Chemotherapy plus granulocyte colony-stimulating factor (GCSF) regimen is one of the available approaches to mobilize peripheral blood progenitor cells (PBPCs). It causes thrombocytopenia and delays leukapheresis. This study aimed to evaluate the role of recombinant human thrombopoietin (rhTPO) before mobilization chemotherapy in facilitating leukapheresis in patients with lymphoma. METHODS In this randomized open-label phase 2 trial, patients were randomly assigned in a 1:2 ratio to receive mobilization with rhTPO plus GCSF in combination with chemotherapy (the rhTPO plus GCSF arm) or GCSF alone in combination with chemotherapy (the GCSF alone arm). The recovery of neutrophils and platelets and the amount of platelet transfusion were monitored. RESULTS Thirty patients were enrolled in this study between March 2016 and August 2018. Patients in the rhTPO plus GCSF arm (n = 10) had similar platelet nadir after mobilization chemotherapy (P=0.878) and similar amount of platelet transfusion (median 0 vs. 1 unit, P=0.735) when compared with the GCSF alone arm (n = 20). On the day of leukapheresis, the median platelet count was 86 × 10(9)/L (range 18-219) among patients who received rhTPO and 73 × 10(9)/L (range 42-197) among those who received GCSF alone (P=0.982). After the use of rhTPO, the incidence of platelet count <75 × 10(9)/L on the day of leukapheresis did not decrease significantly (30.0% vs. 50.0%, P=0.297). Platelet recovery after PBPC transfusion was more rapid in the rhTPO plus GCSF arm (median 8.0 days [95% confidence interval 2.9-13.1] to platelets ≥50 × 10(9)/L vs. 11.0 days [95% confidence interval 8.6-13.4], P=0.011). The estimated total cost of the mobilization and reconstitution phases per patient was similar between the two treatmtent groups (P=0.362 and P=0.067, respectively). CONCLUSIONS Our findings indicate that there was no significant clinical benefit of rhTPO use in facilitating mobilization of progenitor cells, but it may promote platelet recovery in the reconstitution phase after high-dose therapy. TRIAL REGISTRATION This trial has been registered in Clinicaltrials.gov as NCT03014102.
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5.
Erythropoietin prevents necrotizing enterocolitis in very preterm infants: a randomized controlled trial
Wang Y, Song J, Sun H, Xu F, Li K, Nie C, Zhang X, Peng X, Xia L, Shen Z, et al
Journal of translational medicine. 2020;18(1):308
Abstract
BACKGROUND Necrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC. Studies have shown that erythropoietin (EPO) has the potential to prevent NEC or improve outcomes of preterm NEC. This study aimed to determine whether recombinant human EPO (rhEPO) could protect against NEC in very preterm infants. METHODS The study was a prospective randomized clinical trial performed among four NICU centers. A total of 1327 preterm infants with gestational age ≤ 32 weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants to be randomized to the rhEPO or control group. Infants in the rhEPO group were given 500 IU/kg rhEPO intravenously every other day for 2 weeks, while the control group was given the same volume of saline. The primary outcome was the incidence of NEC in very preterm infants at 36 weeks of corrected gestational age. RESULTS A total of 1285 infants were analyzed at 36 weeks of corrected age for the incidence of NEC. rhEPO treatment significantly decreased the incidence of NEC (stage I, II and III) (12.0% vs. 17.1%, p = 0.010), especially confirmed NEC (stage II and III) (3.0% vs. 5.4%, p = 0.027). Meanwhile, rhEPO treatment significantly reduced the number of red blood cells transfusion in the confirmed NEC cases (1.2 ± 0.4 vs. 2.7 ± 1.0, p = 0.004). Subgroup analyses showed that rhEPO treatment significantly decreased the incidence of confirmed NEC at gestational age < 28 weeks (p = 0.019), and the incidence of all stages NEC in preterm infants with hemoglobin < 90 g/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028). CONCLUSION Repeated low-dose rhEPO treatment is beneficial against NEC in very preterm infants. Trial registration The protocol was registered retrospectively at ClinicalTrials.gov (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500.
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6.
Tranexamic acid attenuates inflammatory effect and modulates immune response in primary total knee arthroplasty: a randomized, placebo-controlled, pilot trial
Zhang S, Xu H, Xie J, Cao G, Lei Y, Pei F
Inflammopharmacology. 2020
Abstract
AIMS: To explore the effect of intravenous tranexamic acid (IV-TXA) on inflammation and immune response following primary total knee arthroplasty (TKA). METHODS Primary TKA patients (n = 125) were randomized into the following four groups: group A to receive placebo; group B to receive a single dose of 20 mg kg(-1) IV-TXA and 20 mg of intravenous dexamethasone (IV-DXM); group C to receive six doses of IV-TXA (total dosage > 6 g); and group D to receive six doses of IV-TXA combined with three doses of IV-DXM (total dosage = 40 mg). The primary outcomes were C-reactive protein (CRP) and interleukin (IL)-6 levels and the secondary outcomes were complement C3 and C4 and T-cell subset levels, which were measured preoperatively and at 24 h, 48 h, 72 h, and 2 weeks postoperatively. RESULTS The postoperative peak CRP and IL-6 levels in group C (93.7 +/- 22.2 mg L(-1), 108.8 +/- 41.7 pg mL(-1)) were lower compared with those in group A (134.7 +/- 28.8 mg L(-1), P < 0.01; 161.6 +/- 64.4 pg mL(-1), P < 0.01). Groups B and D exhibited significantly lower CRP and IL-6 levels compared with groups A and C at 24 h, 48 h, and 72 h postoperatively (P < 0.05 for all). In group C, complement C3 and C4 levels were higher compared with those in group A at 48 h (0.967 +/- 0.127 g L(-1) vs. 0.792 +/- 0.100 g L(-1), P < 0.01; 0.221 +/- 0.046 g L(-1) vs. 0.167 +/- 0.028 g L(-1), P < 0.01) and 72 h (1.050 +/- 0.181 g L(-1) vs. 0.860 +/- 0.126 g L(-1), P = 0.01; 0.240 +/- 0.052 g L(-1) vs. 0.182 +/- 0.036 g L(-1), P < 0.01) postoperatively and CD3 and CD4 subset levels were higher compared with those in group B at 24 h postoperatively (66.78 +/- 9.29% vs. 56.10 +/- 12.47%, P < 0.05; 36.69 +/- 5.78% vs. 28.39 +/- 8.89%, P < 0.05). CONCLUSION Six doses of IV-TXA could attenuate the inflammatory effect, modulate the immune response, and reduce immunosuppression caused by DXM in patients after TKA.
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7.
Tranexamic acid safely reduces hidden blood loss in patients undergoing intertrochanteric fracture surgery: a randomized controlled trial
Zhang S, Xiao C, Yu W, Long N, He F, Cai P, Luo K, Jiang Y
Eur J Trauma Emerg Surg. 2020
Abstract
PURPOSE To investigate the efficacy and safety of intravenous tranexamic acid (IV-TXA) in patients undergoing intertrochanteric fracture surgery. METHODS A total of 122 patients were included in this double-blinded trial and equally randomized to receive 1 g of IV-TXA or normal saline 10 min before incision and 3 h later. The primary efficacy outcome was calculated hidden blood loss (HBL). The secondary efficacy outcome was allogeneic erythrocyte transfusion rate during hospitalization. Safety outcome was a composite of thromboembolic events including deep venous thrombosis (DVT) up to 90 days. A meta-analysis combining this study with previous randomized controlled trials in hip fracture surgery (total sample size: 1112 patients) was also conducted. RESULTS The mean HBL in TXA group (640.96 +/- 421.63 ml) was significantly lower than that in placebo group (1010.11 +/- 398.96 ml, P < 0.001). The rate of erythrocyte transfusions was 29.5% in TXA group and 60.7% in placebo group (P = 0.001). The incidence of thromboembolic events at 90 days was 4.9% in TXA group and 1.6% in placebo group (P = 0.619). The updated meta-analysis showed that IV-TXA significantly reduced erythrocyte transfusion in hip fracture surgery (risk ratio 0.60, 95% confidence intervals 0.53-0.68), and IV-TXA caused no increased risk of thromboembolic events (risk difference 0.01, 95% confidence intervals - 0.02-0.04). CONCLUSION IV-TXA could effectively reduce the HBL and allogeneic erythrocyte transfusion requirements in patients undergoing intertrochanteric fracture surgery without an increase of thromboembolic events including DVT. TRIAL REGISTRATION Clinical trials: safety and efficiency of tranexamic acid in hip fracture patients. Date of registration: August 31, 2018. TRIAL REGISTRATION NUMBER ChiCTR1800018110.
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8.
Six-Dose Intravenous Tranexamic Acid Regimen Further Inhibits Postoperative Fibrinolysis and Reduces Hidden Blood Loss Following Total Knee Arthroplasty
Zhang S, Xie J, Cao G, Lei Y, Huang Q, Pei F
The journal of knee surgery. 2019
Abstract
There is no consensus regarding the ideal dosages and times of multiple-dose intravenous tranexamic acid (IV-TXA) administration in total knee arthroplasty (TKA). This study aimed to assess the effect of six-dose IV-TXA with the total dosage more than 6 g on postoperative fibrinolysis and hidden blood loss (HBL) after primary TKA. A total of 175 patients were randomized into three groups to receive placebo (group A), or a single preoperative dose of 20 mg/kg IV-TXA (group B), or six-dose IV-TXA from the beginning of the procedure to subsequent 24 hours with the total dosage more than 6 g (group C). The calculated HBL, maximum hemoglobin (Hb) drop, transfusion rate, and the incidence of thromboembolic events were compared among groups. The levels of fibrinolysis parameters in plasma including fibrin(-ogen) degradation products (FDP) and D-dimer were measured at six time points from preoperatively to 3-month postoperative period. The mean HBL and maximum Hb drop in group C (515.51 +/- 245.79 mL, and 2.06 +/- 0.73 g/dL, respectively) were significantly lower than those in groups B (756.06 +/- 226.79 mL, p < 0.001; and 2.77 +/- 0.78 g/dL, p < 0.001, respectively) and A (987.65 +/- 275.38 mL, p < 0.001; and 3.49 +/- 0.86 g/dL, p < 0.001, respectively). Such differences were also detected between groups A and B (p < 0.001 and p < 0.001, respectively). The levels of FDP and D-dimer in plasma were lower in group C than those in groups B and A on postoperative 24, 48, 72 hours (p < 0.001 for all). No episode of transfusion occurred, and the incidence of thromboembolic events were similar among groups (p > 0.05). The administration of six-dose IV-TXA during the first 24 hours resulted in reduced HBL following TKA without a measured increase in thromboembolic events.
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9.
Platelet-rich fibrin as an alternative adjunct to tendon-exposed wound healing: A randomized controlled clinical trial
Zhang S, Cao D, Xie J, Li H, Chen Z, Bao Q
Burns : journal of the International Society for Burn Injuries. 2019
Abstract
BACKGROUND The use of platelet-rich fibrin (PRF) has attracted great interest in the treatment of oral and maxillofacial procedures, gingival recessions, and bone healing. However, PRF has been reported hardly to prepare wound bed before skin grafting. This randomized clinical study sought to identify the effect of PRF as an alternative adjunct to tendon-exposed wound healing. METHODS Thirty-six patients with tendon-exposed wounds were treated by applying Integra or PRF (n=18 per group). The take rate of Integra or PRF and pain levels assessed with the four-point verbal rating scale (VRS-4) for the first 5days after application were measured for each condition. Data of texture change analysis were assessed and recorded for a duration of 3 months postoperatively. RESULTS The take rate was less in the Integra group than in the PRF group (92.39 vs 97.83 P<0.001). After surgery, compared to the Integra group, the patients in the PRF group reported significantly lower pain scores (P<0.001). Texture changes from the Integra group were rated higher than those from the PRF (P<0.001). CONCLUSION The use of PRF could be an option for tendon exposed areas where the wound is unfit for standard skin grafting or flap transfer.
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10.
Multi-route applications of tranexamic acid to reduce blood loss after total knee arthroplasty: a randomized controlled trial
Zhang S, Wang C, Shi L, Xue Q
Medicine. 2019;98(30):e16570
Abstract
BACKGROUND Perioperative bleeding during total knee arthroplasty (TKA) is an ongoing problem for surgeons. Intravenous or topical application of tranexamic acid (TXA) can effectively stop bleeding, but there is still no uniform standard for the best method of administration and dose. METHODS From October 2016 to September 2018, 218 patients with unilateral primary knee osteoarthritis requiring knee replacement were enrolled and randomly divided into four groups. Group 1 (n = 55) received intra-articular injection (IAI) of TXA and peri-articular injection (PAI) of placebo, group 2 (n = 55) received IAI of placebo and PAI of TXA, group 3 (n = 51) received IAI of TXA and PAI of TXA, and group 4 (n = 57) received double placebo (IAI of placebo and PAI of placebo). The demographic characteristics, surgical indices, hematological indices, wound healing history, and thromboembolic events were investigated. RESULTS Eight patients were lost to follow-up and 210 patients were included in the analysis. The median TBLs in patients who received IAI of TXA and PAI of placebo and those who received IAI of placebo and PAI of TXA were 470.81 ml and 481.54 ml, respectively. These TBL levels were significantly higher compared to those in patients who received IAI of TXA and PAI of TXA (359.18 ml, P ≤ .001), but significantly lower compared to those in patients who received the double placebo (522.71 ml, P ≤ .001). Compared to other groups, more patients in the double placebo group needed a blood transfusion (P = .013). In the short-term, the double placebo group had higher VAS pain scores and less ROM after surgery (P = .011 and P = .001, respectively). In the long-term (6-month follow-up), there were no significant differences in ROM, VAS, DVT, PE, or wound-related complications. CONCLUSION The combined use of IAI and PAI of TXA can significantly reduce the TBL and the need for blood transfusion without delaying wound healing or increasing the risk of DVT and PE. In the short-term after surgery, this combined method reduces the pain VAS scores and improves the ROM; however, there are no long-term effects on VAS and ROM.