Objective To investigate the safety and efficacy of different doses of tranexamic acid (TXA) in posterior cervical laminectomy with lateral mass screw fixation and bone graft fusion by a prospective clinical study. Methods The middle-aged and elderly patients with cervical spondylotic myelopathy, who were admitted between January 2020 and January 2022 and scheduled to undergo posterior cervical laminectomy with lateral mass screw fixation and bone graft fusion, were studied as the research subjects. Among them, 165 patients met the selection criteria and were included in the study. The patients were allocated into 3 groups (n=55) by random double-blind lottery. Groups A and B were given intravenous infusion of TXA at 30 minutes before operation according to the standards of 15 and 30 mg/kg, respectively; and group C was given normal saline in the same way. There was no significant difference in gender, age, body mass index, and preoperative D-dimer, hemoglobin (Hb), and hematocrit (HCT) between groups (P>0.05). The intraoperative bleeding, intraoperative blood transfusion, postoperative drainage volume, drainage days, and postoperative hospital stay were recorded. The Hb, HCT, and D-dimer were compared before operation and at 3 days after operation. Venous ultrasonography of the lower extremities was taken after operation to assess thrombosis; and the postoperative hematoma and epilepsy were also observed. Results All operations were successfully completed, and the incisions healed by first intention. The differences in intraoperative bleeding volume, postoperative drainage volume, drainage days, and postoperative hospital stay between groups were significant (P<0.05). The above indexes were significantly less in group B than in groups A and C. During operation, 14 patients in group A and 23 patients in group C were transfused, and no patient in group B had blood transfusions. Compared with groups A and C, the blood transfusion volume in group B significantly decreased (P<0.05), and the difference between groups A and C was not significant (P>0.05). There was no significant difference in the differences of D-dimer, Hb, and HCT before and after operation between groups (P>0.05). At 5 days after operation, the venous ultrasonography of the lower extremities showed that the 2 cases of intermuscular venous thrombosis occurred in groups A, B, and C, respectively. No hematoma or epilepsy occurred after operation. Conclusion The application of 15 and 30 mg/kg TXA in posterior cervical laminectomy with lateral mass screw fixation and bone graft fusion can reduce intraoperative bleeding and postoperative drainage volume, postoperative drainage days, and postoperative hospital stay. And application of 30 mg/kg TXA can reduce intraoperative blood transfusion, without increasing the risk of lower extremity venous thrombosis, hematoma, and epilepsy.
ObjectiveTo investigate the efficacy and safety of multiple-dose intravenous tranexamic acid (TXA) for reducing blood loss in complex tibial plateau fractures with open reduction internal fixation by a prospective randomized controlled trial. MethodsA study was conducted on patients with Schatzker type Ⅳ-Ⅵ tibial plateau fractures admitted between August 2020 and December 2022. Among them, 88 patients met the selection criteria and were included in the study. They were randomly allocated into 3 groups, the control group (28 cases), single-dose TXA group (31 cases), and multiple-dose TXA group (29 cases), using a random number table method. There was no significant difference (P>0.05) in terms of age, gender, body mass index, the Schatzker type and side of fracture, laboratory examinations [hemoglobin (Hb), activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fib), international normalized ratio (INR), D-dimer, and interleukin 6 (IL-6)], and preoperative blood volume. The control group received intravenous infusion of 100 mL saline at 15 minutes before operation and 3, 6, and 24 hours after the first administration. The single-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at 15 minutes before operation, followed by an equal amount of saline at each time point after the first administration. The multiple-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at each time point. The relevant indicators were recorded and compared between groups to evaluate the effectiveness and safety of TXA, including hospital stays, operation time, occurrence of infection; the occurrence of lower extremity deep vein thrombosis, intermuscular vein thrombosis, and pulmonary embolism at 1 week after operation; the lowest postoperative Hb value and Hb reduction rate, the difference (change value) between pre- and post-operative APTT, PT, Fib, and INR; D-dimer and IL-6 at 24 and 72 hours after operation; total blood loss, intraoperative blood loss, hidden blood loss, drainage flow during 48 hours after operation, and postoperative blood transfusion. Results ① TXA efficacy evaluation: the lowest Hb value in the control group was significantly lower than that in the other two groups (P<0.05), and there was no significant difference between the single- and multiple-dose TXA groups (P>0.05). The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant (P<0.05) in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. ② TXA safety evaluation: no lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation, but 3, 4, and 2 cases of intermuscular vein thrombosis occurred in the control group, single-dose TXA group, and multiple-dose TXA group, respectively, and the differences in the incidences between groups were not significant (P>0.05). There was no significant difference in the operation time between groups (P>0.05). But the length of hospital stay was significantly longer in the control group than in the other groups (P<0.05); there was no significant difference between the single- and multiple-dose TXA groups (P>0.05). ③ Effect of TXA on blood coagulation and inflammatory response: the incisions of the 3 groups healed by first intention, and no infections occurred. The differences in the changes of APTT, PT, Fib, and INR between groups were not significant (P>0.05). The D-dimer and IL-6 in the three groups showed a trend of first increasing and then decreasing over time, and there was a significant difference between different time points in the three groups (P<0.05). At 24 and 72 hours after operation, there was no significant difference in D-dimer between groups (P>0.05), while there was a significant difference in IL-6 between groups (P<0.05). Conclusion Multiple intravenous applications of TXA can reduce perioperative blood loss and shorten hospital stays in patients undergoing open reduction and internal fixation of complex tibial plateau fractures, provide additional fibrinolysis control and ameliorate postoperative inflammatory response.
Objective To systematically review the clinical efficiency and safety after topical administration of tranexamic acid in total hip arthroplasty. Methods Relevant randomized controlled trials were identified from databases such as Cochrane Library, PubMed, Embase and CNKI from the establishment of the database to August, 2017. A systematic review was performed to compare total blood loss, the rate of transfusion and thromboembolism events between the tranexamic acid group and the control group. And the patients in tranexamic acid group were treated with tranexamic acid for hemorrhage after total hip arthroplasty, while the patients in the control group were not treated with tranexamic acid or used isotonic saline. Analysis was carried out using Review Manager version 5.2.0 software. Results Eight studies were incorporated into the Meta-analysis. The results of Meta-analysis showed that there was significant difference in total blood loss between two groups [weighted mean difference (WMD)=–360.27 mL, 95% confidence interval (CI) (–412.68, –307.87) mL, P<0.000 01]. There was significant difference in the rate of transfusion between two groups [ (odds ratio,OR)=0.22, 95%CI (0.14, 0.33), P<0.000 01]. There was no significant difference in complications between two groups [OR=1.48, 95%CI (0.41, 5.34), P=0.55]. Conclusion Topical administration of tranexamic acid could significantly reduce total blood loss and transfusion requirements in primary total hip arthroplasty, and would not increase thromboembolic complications.
ObjectiveTo investigate the safety and efficiency of intravenous tranexamic acid (TXA) to reduce blood loss in total knee arthroplasty (TKA). MethodsA prospective, randomized, self-controlled study was carried out on 60 patients scheduled for bilateral TKA between January 2012 and December 2013. TXA (10 mg/kg) was injected intravenously approximately 10 minutes before tourniquet release when TKA was performed on one side (TXA group), and TXA was not used on the other side (control group). No significant difference was found in the preoperative hemoglobin (Hgb), platelet (PLT) count, prothrombin time (PT), and activated partial thromboplastin time (APTT) between 2 groups (P>0.05). The amount of drainage, the total blood loss, the hidden blood loss, the postoperative Hgb, the amount of blood transfusion, the ratio of blood transfusion, and the incidence of vein thrombosis embolism (VTE) were compared between 2 groups. ResultsThe amount of drainage and total blood loss were significantly less in the TXA group than in control group (P<0.05), and the Hgb was significantly lower in the control group than in the TXA group at 6 hours, 1, 3, and 7 days after operation (P<0.05). There was no significant difference in the hidden blood loss between 2 groups (t=1.157, P=0.252). The ratio of blood transfusion was significantly less in TXA group (6.7%, 4/60) than in control group (21.7%, 13/60)(P=0.034). The total amount of blood transfusion was 14 units in TXA group, which was significantly less than that of control group (38 units) (P=0.004). Deep vein thrombosis occurred in 3 cases in 2 groups respectively, showing no significant difference (P=1.000). There was no symptomatic pulmonary embolism. All patients were followed up for 8-17 months, with an average of 13.7 months. No new VTE case was found during the follow-up period. ConclusionIntravenous injection of TXA (10 mg/kg) at 10 minutes before tourniquet release in TKA is effective in reducing perioperative blood loss, amount of blood transfusion, and ratio of transfusion, and it will not increase the risk of VTE.
ObjectiveTo evaluate the efficacy and safety of a loading high-dose tranexamic acid (TXA) followed by postoperative 5 doses in total hip arthroplasty (THA) by a randomized controlled trial.MethodsSeventy-two patients who underwent primary unilateral THA between December 2017 and March 2018 were randomly divided into two groups (36 patients in each group). A single dose of 20 mg/kg TXA was administered intravenously before 5-10 minutes of operation in group A; and a single dose of 40 mg/kg TXA was administered intravenously in group B at the same time point. All patients received 5 doses of 1 g TXA at 3, 6, 12, 18, and 24 hours after the first dose. There was no significant difference in gender, age, weight, height, body mass index, disease type, and combined medical diseases between the two groups (P>0.05). Total blood loss (TBL), lowest postoperative hemoglobin (Hb) level, fibrinolysis parameters [fibrin (ogen) degradation products (FDP), D-dimer], inflammatory factors [C-reaction protein (CRP), interleukin-6 (IL-6)], adverse events (thrombosis, pulmonary embolism) were recorded and compared between groups.ResultsThe TBL was significantly lower in group B than in group A (P<0.05). Furthermore, the lowest postoperative Hb level was significantly higher in group B than in group A (P<0.05). There was no significant difference in FDP and D-dimer before operation between the two groups (P>0.05). The levels of FDP and D-dimer were significantly lower in group B than in group A at 12 and 36 hours postoperatively (P<0.05). There was no significant difference in CRP and IL-6 before operation between the two groups (P>0.05). The levels of CRP and IL-6 were significant lower in group B than in group A at 12, 24, and 36 hours postoperatively (P<0.05). There was no significant difference at 14 days (P>0.05). There were 2 patients with intramuscular venous thrombosis in group A and 1 in group B after operation, and there was no significant difference in the incidence of embolic events (P>0.05). No deep venous thrombosis or pulmonary embolism occurred in all groups.ConclusionA loading high-dose TXA followed by postoperative 5 doses can further reduce the blood loss, provide additional fibrinolysis and inflammation control in THA, without increasing the risk of embolic events.
Objective To explore the effect of intravenous tranexamic acid on postoperative drainage and elbow joint function after traumatic elbow stiffness release. Methods The clinical data of 44 patients with elbow joint stiffness who were treated with release surgery between March 2022 and December 2023 and met the selection criteria were retrospectively analyzed. Among them, 20 patients were given intravenous infusion of 100 mL (1 g/100 mL, once a day) of tranexamic acid solution for 3 consecutive days after surgery (group A), and 24 patients were not treated with tranexamic acid after surgery (group B). There was no significant difference in baseline data such as gender, age, side, body mass index, initial injury, and preoperative hemoglobin, visual analogue scale (VAS) score, and Mayo elbow function score (MEPS), elbow flexion and extension activity between the two groups (P>0.05). The drainage volume at 1 day and 3 days after operation, total drainage volume, drainage tube indwelling time, postoperative hospital stay, VAS score before operation and at 1, 2, and 3 days after operation, MEPS score before operation, at 3 months after operation, and at last follow-up, and elbow flexion and extension activity before operation and at last follow-up were recorded and compared between the two groups. Results Both groups of patients successfully completed the operation, and there was no significant difference in operation time (P>0.05). The drainage volume at 1 day and 3 days after operation, total drainage volume, drainage tube indwelling time, and postoperative hospital stay in group A were significantly less than those in group B (P<0.05). Both groups of patients were followed up 6-12 months, with an average of 8.6 months. No complications such as wound infection, elbow joint varus and varus instability or dislocation, and pulmonary embolism or other thromboembolic events occurred in either group. The VAS scores of both groups were significantly higher at 1 day and 2 days after operation than before operation (P<0.05); the VAS score of group A was significantly lower than that of group B (P<0.05). The VAS scores of both groups decreased to the preoperative level at 3 months after operation, and there was no significant difference between the two groups (P>0.05). At 3 months after operation and at last follow-up, the MEPS scores of both groups significantly improved when compared with those before operation (P<0.05); there was no significant difference between the two groups (P>0.05). At last follow-up, the postoperative elbow flexion and extension activity of the two groups significantly increased when compared with that before operation (P<0.05); there was no significant difference in change of elbow flexion and extension activity between the two groups (P>0.05). ConclusionIntravenous tranexamic acid for 3 consecutive days after release of traumatic elbow stiffness can significantly reduce postoperative drainage volume, shorten drainage tube indwelling time and hospital stay, and relieve early postoperative pain, but it has no effect on the risk of thrombotic and embolic events and postoperative elbow function.
ObjectiveTo compare the hemostatic effect and safety in primary unilateral total hip arthroplasty (THA) receiving nadroparin calcium, enoxaparin sodium, rivaroxaban, or apixaban after anti-fibrinolysis with tranexamic acid (TXA) and explore the best anticoagulant.MethodsA retrospective analysis was conducted on 184 patients who underwent the primary unilateral THA between January 2014 and December 2018, administrated 15 mg/kg TXA before surgery and received nadroparin calcium, enoxaparin sodium, rivaroxaban, or apixaban. The patients were divided into four groups based on the different anticoagulants: 46 patients received nadroparin calcium; 45 patients received enoxaparin sodium; 47 patients received rivaroxaban; the other 46 patients received apixaban. There was no significant difference in age, gender, body mass, body mass index, the types of hip joint diseases, complications, anesthesia mode, operation time, and preoperative laboratory indexes (hemoglobin, hematocrit, platelet, prothrombin time, activated partial prothrombin time, blood volume) (P>0.05). Perioperative blood data (total blood loss, hidden blood loss, dominant blood loss, postoperative drainage volume, maximum loss of hemoglobin, and blood transfusion rate) and complications (incision, bleeding, and thrombosis) were recorded and compared between groups.ResultsThere was no significant difference in total blood loss, hidden blood loss, dominant blood loss, postoperative drainage volume, maximum loss of hemoglobin, and blood transfusion rate between groups (P>0.05). The comparison of postoperative complications showed that 1 case (2.1%) of redness and swelling of incision occurred in the rivaroxaban group, and 1 case (2.2%) of the other 3 groups each had poor incision healing. No incision infection, fat liquefaction, or other incision complications occurred in the 4 groups. There was no significant difference in incision complication between groups (P>0.05). There were 2 cases (4.3%) bleeding events (1 case of right inguinal hematoma and 1 case of subcutaneous ecchymosis in front of left leg) in the nadroparin calcium group, while no bleeding event occurred in the other 3 groups, which had no significant difference in bleeding complication between groups (χ2=5.612, P=0.132). There was 1 case (2.2%) of intermuscular vein thrombosis of the lower extremity in the nadroparin calcium group and no case in the other 3 groups, which had no significant difference between groups (χ2=2.789, P=0.425). Neither deep venous thrombosis nor pulmonary embolism occurred in any group.ConclusionNo significant difference in the hemostatic effect and incidences of complications for patients underwent primary unilateral THA receiving nadroparin calcium, enoxaparin sodium, rivaroxaban, or apixaban after anti-fibrinolysis with TXA. One of the four anticoagulants can be selected to prevent thrombosis after anti-fibrinolysis with TXA, which has certain safety.
ObjectiveTo analyze the reporting and methodological quality of tranexamic acid meta-analyses published in Chinese journals. MethodsThe CNKI, WanFang Data, and CBM databases were electronically searched for meta-analyses of tranexamic acid from inception to August 12th, 2021. Two reviewers independently screened literature, extracted data, and used AMSTAR 2 and PRISMA 2009 to assess the methodological and reporting quality of publications. ResultsA total of 68 meta-analyses were included. The identified meta-analyses required improvement for items 2, 3, 4, 7, 8, 10, 12, 15, and 16 in the AMSTAR 2, and items 2, 5, 8, 12, 15, 17, 22, 24, and 27 in the PRISMA 2009 assessments, respectively. The methodological and reporting quality scores were positively correlated (rs=0.36, P=0.002). Linear regression analysis identified the mentioning of PRISMA and funding support as the independent factors potentially affecting the reporting quality score (P<0.05). ConclusionsBoth the methodological and reporting quality of the tranexamic acid meta-analyses published in Chinese journals require improvement.
Objective To evaluate the effectiveness and safety of intraoperative tranexamic acid use in total shoulder arthroplasty. Methods By searching Cochrane Library, PubMed, Embase, Chongqing VIP, Chinese National Knowledge Infrastructure, Wanfang Database from the establishment of the database to September 2021, randomized controlled trials of intraoperative tranexamic acid use in total shoulder arthroplasty were collected. Outcome indicators were total blood loss, postoperative drainage, hemoglobin reduction, length of operation, length of hospital stay, and formation of hematoma. RevMan 5.3 software was used for meta-analysis. Results Meta analysis results showed that the use of tranexamic acid can reduce total blood loss [weighted mean difference = −246.55 mL, 95% confidence interval (−335.36, −157.75) mL, P<0.000 01], reduce postoperative drainage [weighted mean difference = −134.05 mL, 95% confidence interval (−161.72, −106.38) mL, P<0.000 01], reduce hemoglobin reduction [weighted mean difference = −0.64 g/dL, 95% confidence interval (−0.91, −0.36) g/dL, P< 0.000 01], reduce hematoma formation [risk ratio=0.41, 95% confidence interval (0.22, 0.77), P=0.005]. There was no statistically significant difference in the length of operation and length of hospitalization between patients who used tranexamic acid and those who did not use tranexamic acid (P>0.05). Conclusions Tranexamic acid is effective and safe for patients undergoing total shoulder arthroplasty. It can reduce perioperative bleeding and hematoma formation without increasing the length of surgery and hospitalization.
ObjectiveTo systematically review the clinical efficacy and safety of postpartum hemorrhage (PPH) prophylaxis with a single dose of tranexamic acid (TXA). MethodsThe Embase, PubMed, WanFang Data, VIP, CNKI, ChiCTR and Cochrane Library were electronically retrieved to collect clinical studies related to appraising the efficacy and safety in parturients after cesarean section used TXA perioperatively from inception to September, 2024. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using R software. A trial sequential analysis of outcomes was carried out to investigate the reliability and conclusiveness of findings. ResultsA total of 43 RCTs including 23 497 parturients that compared the prophylactic use of a single dose of TXA with placebo or no treatment in parturients undergoing cesarean delivery. The results of meta-analysis revealed that there was a significantly reduced risk of PPH (RR=0.52, 95%CI 0.40 to 0.67, P<0.01), total blood loss (SMD=−183.73mL, 95%CI −220.87 to −146.60, P<0.01), need for blood transfusion (RR=0.42, 95%CI 0.30 to 0.60, P<0.01), and use of additional uterotonics (RR=0.55, 95%CI 0.43 to 0.70, P<0.01) with TXA use. There were no statistical differences in thromboembolic events between TXA and control groups (RR=1.05, 95%CI 0.54 to 2.03, P=0.11), and results were consistently in favor of TXA use across subgroups, and trial sequential analyses. ConclusionTaken as a whole, existing evidence suggests that TXA can effectively reduce PPH in patients undergoing cesarean delivery. Further, prophylactic TXA administration for parturients significantly reduced blood loss and need for blood transfusion, without increasing adverse events and use of additional uterotonics, supporting its use as a safe and effective strategy for reducing PPH in this population.