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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.
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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4.
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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Is intravenous tranexamic acid effective and safe during hip fracture surgery? An updated meta-analysis of randomized controlled trials
Xiao C, Zhang S, Long N, Yu W, Jiang Y
Archives of orthopaedic and trauma surgery. 2019
Abstract
INTRODUCTION The efficacy and safety of intravenous (IV) tranexamic acid (TXA) during hip fracture surgery remain controversial. This meta-analysis aimed to assess the efficacy of IV-TXA administration during hip fracture surgery for reducing the transfusion requirement and blood loss as well as its safety regarding the risk of thrombolysis. MATERIALS AND METHODS PubMed, EMBASE, Web of Science, and the Cochrane Library Database were systematically searched for randomized controlled trials (RCTs) that focused on the efficacy and safety of IV-TXA in patients during hip fracture surgery. The primary outcome was the transfusion requirement. Secondary outcomes included total blood loss (TBL), deep vein thrombosis (DVT), and total thromboembolic events (TTEs). Risk ratio (RR), risk difference (RD), and mean difference (MD) for dichotomous and continuous data outcomes were determined from the meta-analysis. Data were analyzed using Rev Man 5.3. RESULTS Altogether, 11 RCTs were included (total sample size 892 patients). IV-TXA significantly reduced the transfusion requirement [RR 0.60, 95% confidence interval (CI) 0.38-0.93, P = 0.02] and TBL (MD 326.64 ml, 95% CI - 462.23 to - 191.06, P < 0.00001) vs. cosntrol group. IV-TXA caused no increased risk of DVT (RD 0.02, 95% CI - 0.01 to 0.04, P = 0.13) or TTEs (RD 0.02, 95% CI - 0.01 to 0.05, P = 0.12). CONCLUSION Available evidence indicates that IV-TXA efficaciously reduces TBL and transfusion requirements during hip fracture surgery without significantly increasing the risk of TTEs including DVT.
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Different dose regimes and administration methods of tranexamic acid in cardiac surgery: a meta-analysis of randomized trials
Guo J, Gao X, Ma Y, Lv H, Hu W, Zhang S, Ji H, Wang G, Shi J
BMC anesthesiology. 2019;19(1):129
Abstract
BACKGROUND The efficacy of tranexamic acid (TXA) to reduce perioperative blood loss and allogeneic blood transfusion in cardiac surgeries has been proved in previous studies, but its adverse effects especially seizure has always been a problem of concern. This meta-analysis aims to provide information on the optimal dosage and delivery method which is effective with the least adverse outcomes. METHODS We searched Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE for all relevant articles published before 2018/12/31. Inclusion criteria were adult patients undergoing elective heart surgeries, and only randomized control trials comparing TXA with placebo were considered. Two authors independently assessed trial quality and extracted relevant data. RESULTS We included 49 studies with 10,591 patients into analysis. TXA significantly reduced transfusion rate (RR 0.71, 95% CI 0.65 to 0.78, P<0.00001). The overall transfusion rate was 35%(1573/4477) for patients using TXA and 49%(2190/4408) for patients in the control group. Peri-operative blood loss (MD - 246.98 ml, 95% CI - 287.89 to - 206.06 ml, P<0.00001) and re-operation rate (RR 0.62, 95% CI 0.49 to 0.79, P<0.0001) were also reduced significantly. TXA usage did not increase risk of mortality, myocardial infarction, stroke, pulmonary embolism and renal dysfunction, but was associated with a significantly increase in seizure attack (RR 3.21, 95% CI 1.04 to 9.90, P = 0.04).The overall rate of seizure attack was 0.62%(21/3378) for patients using TXA and 0.15%(5/3406) for patients in the control group. In subgroup analysis, TXA was effective for both on-pump and off-pump surgeries. Topical application didn't reduce the need for transfusion requirement, while intravenous delivery no matter as bolus injection alone or bolus plus continuous infusion were effective. Intravenous high-dose TXA didn't further decrease transfusion rate compared with low-dose regimen, and increased the risk of seizure by 4.83 times. No patients in the low-dose group had seizure attack. CONCLUSIONS TXA was effective in reducing transfusion requirement in all kinds of cardiac surgeries. Low-dose intravenous infusion was the most preferable delivery method which was as effective as high-dose regimen in reducing transfusion rate without increasing the risk of seizure.
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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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8.
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.
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9.
The effect of oral versus intravenous tranexamic acid in reducing blood loss after primary total hip arthroplasty: A randomized clinical trial
Cao G, Huang Z, Xie J, Huang Q, Xu B, Zhang S, Pei F
Thrombosis Research. 2018;164:48-53.
Abstract
BACKGROUND The purpose of this study was to determine whether the administration of multiple boluses of oral and intravenous tranexamic acid (TXA) postoperatively was equivalent in reducing blood loss in primary THA. METHODS A total of 108 patients were randomized into two groups: oral TXA group (54 patients receiving 1 dose of 20mg/kg intravenous TXA 5-10min before skin incision and 3 doses of 2g oral TXA 4h, 10h and 16h postoperatively) and intravenous TXA group (54 patients receiving 1 dose of 20mg/kg intravenous TXA 5-10min before skin incision and 3 doses of 1g intravenous TXA 6h, 12h and 18h postoperatively). The primary outcomes were total blood loss, hidden blood loss, length of hospital stay, hemoglobin (Hb) and hematocrit (Hct) drop. The secondary outcomes were the level of inflammation markers and complications. RESULTS There was no difference in the mean total blood loss or hidden blood loss [728.4 (645.8-806.9) mL vs 703.6 (576.9-832.8) mL, p=0.745; 634.6 (552.0-715.7) mL vs 606.4 (480.1-734.5) mL, p=0.710] and length of hospital stay was similar between the two groups. No patients received allogenic blood transfusion. The Hb and Hct drop on the first and second postoperative days were similar (p>0.05). The level of inflammation markers did not reach statistical significance. The incidence of complications did not differ significantly between the two groups. CONCLUSIONS Multiple boluses of oral TXA and intravenous TXA postoperatively are equivalent in reducing blood loss, Hb and Hct drop in primary THA without increasing the risk of thromboembolic diseases and wound complications.
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The efficacy and safety of multiple-dose oral tranexamic acid on blood loss following total hip arthroplasty: a randomized controlled trial
Cao G, Huang Q, Huang Z, Zhang S, Luo Z, Lei Y, Zhou Z, Pei F
International Orthopaedics. 2018
Abstract
PURPOSES To explore the efficacy and safety of multiple-dose oral tranexamic acid (TXA) on blood loss following primary total hip arthroplasty (THA). METHODS A total of 152 patients were randomized into three groups to receive 2 g of oral TXA two hours pre-operatively (group A), or another bolus of 2 g of oral TXA four hours post-operatively (group B), or another three boluses of 2 g of oral TXA four, ten, and 16 hours post-operatively (group C). The primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and transfusion rate. The secondary outcomes were haemoglobin (Hb) and haematocrit (Hct) drop, the level of fibrinolysis parameters (fibrin degradation products, D-dimer), and complications (thrombotic diseases, stroke, cardiac infarction, and infection). RESULTS The mean TBL and HBL in group C were lower than those in group A (p < 0.001 and p < 0.001) and group B (p = 0.012 and p = 0.029). The Hb drop on post-operative day one (POD1) and POD3 in group C was lower than those in group A (p < 0.001 and p = 0.029) and group B (p < 0.001 and p = 0.004). The difference was similar regarding Hct drop on POD3 (p < 0.001 and p = 0.014). Moreover, fibrin degradation products and D-dimer in group C were lower than in groups A and B on POD1 and POD3 (p < 0.001 and p < 0.001). The incidence of complications such as venous thromboembolism did not differ significantly among the three groups (p > 0.05). CONCLUSIONS Multiple boluses of oral TXA could further reduce blood loss, Hb and Hct drop, and restrain post-operative fibrinolysis in primary THA without increasing the risk of complications. LEVEL OF EVIDENCE I Therapeutic study.