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 explore the effectiveness and safety of tranexamic acid (TXA) in anterior approach surgery for thoracolumbar fractures.MethodsFrom January 2017 to January 2020, a total of 68 thoracolumbar fracture patients undergoing anterior approach surgery were included and randomly divided into TXA group (n=33) and control group (n=35). Patients in the TXA group were given a dose of 15 mg/kg of TXA by intravenous infusion during 30 min before skin incision and an additional 15 mg/kg of TXA intravenously at 8 h after the first infusion, while the ones in the control group were given 15 mg/kg of normal saline at the same time. Basic data of the patients were collected. The hemoglobin concentration, hematocrit, coagulation and fibrinolysis indexes of the patients were monitored preoperatively, 24-hour postoperatively, and 72-hour postoperatively. The intraoperative blood loss and wound drainage of the patients were recorded. The incidence of blood transfusion and thrombotic events were collected. Statistical analysis was performed.ResultsThere was no significant difference in age, sex, body mass index, operation time, fracture location distribution, anesthesia classification of American Society of Anesthesiologists, neurologic grade of American Spinal Injury Association, injury time, or length of hospital stay between the two groups (P>0.05). Compared with those in the control group, the total blood loss [(1 398.49±312.24) vs. (1 642.30±357.78) mL, P=0.003], intraoperative blood loss [(432.83±74.76) vs. (486.31±86.51) mL, P=0.008], and wound drainage [(276.73±89.42) vs. (389.24±125.71) mL, P<0.001] in the TXA group reduced. No statistically significant difference was found between the two groups in the preoperative hemoglobin or hematocrit (P>0.05), but the 24-hour postoperative hemoglobin concentration [(112.67±20.59) vs. (102.64±19.41) g/L, P=0.042] and hematocrit [(32.25±4.12)% vs. (30.13±4.28)%, P=0.042] in the TXA group were higher than those in the control group. The incidence of allogeneic blood transfusion in the TXA group was lower than that in the control group (6.1% vs. 25.7%, P<0.05). There was no statistically significant difference in preoperative, 24-hour postoperative, or 72-hour postoperative prothrombin time, international standardized ratio, activated partial prothrombin time, platelet count, fibrinogen, d-dimer, or fibrinogen degradation products between the two groups (P>0.05), and no thrombotic complications were found.ConclusionTXA has good efficacy and safety in the anterior approach surgery for thoracolumbar fractures.
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.
Objective A prospective randomized controlled trial was conducted to study the effectiveness and safety of intravenous different doses tranexamic acid (TXA) in single-level unilateral minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). Methods The patients treated with single-level unilateral MIS-TLIF between September 2019 and October 2020 were enrolled and randomly classified into low-dose TXA (LD) group (n=39), high-dose TXA (HD) group (n=39), and placebo-controlled (PC) group (n=38). The LD, HD, and PC groups received intravenous TXA 20 mg/kg, TXA 50 mg/kg, the same volume of normal saline at 30 minute before skin incision after general anesthesia, respectively. There was no significant difference on baseline characteristics and preoperative laboratory results among 3 groups (P>0.05), including age, gender, body mass index, surgical segments, hematocrit (HCT), hemoglobin (HGB), prothrombin time (PT), international normalized ratio (INR), D-dimer, fibrin degradation products (FDP), activated partial prothromboplastin time (APTT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (Cr), urea. The intraoperative blood loss (IBL), postoperative drainage volume, operation time, total blood loss (TBL), hidden blood loss (HBL), blood transfusion, hematological examination indexes on the first day after operation, and the incidence of complications within 1 month were compared among the 3 groups. Results There were 3, 2, and 4 patients in the LD, HD, and PC groups who underwent autologous blood transfusion, respectively, and there was no allogeneic blood transfusion patients in the 3 groups. There was no significant difference in IBL, postoperative drainage volume, and operation time between groups (P>0.05). The TBL, HBL, and the decreased value of HGB in LD and HD groups were significantly lower than those in PC group (P<0.05), and TBL and HBL in HD group were significantly lower than those in LD group (P<0.05); the decreased value of HGB between LD group and HD group showed no significant difference (P>0.05). On the first day after operation, D-dimer in LD and HD groups were significantly lower than that in PC group (P<0.05); there was no significant difference between LD and HD groups (P>0.05). There was no significant difference in other hematological indexes between groups (P>0.05). All patients were followed up 1 month, and there was no TXA-related complication such as deep venous thrombosis of lower extremity, pulmonary embolism, and epilepsy in the 3 groups. ConclusionIntravenous administration of TXA in single-level unilateral MIS-TLIF is effective and safe in reducing postoperative TBL and HBL within 1 day in a dose-dependent manner. Also, TXA can reduce postoperative fibrinolysis markers and do not increase the risk of thrombotic events, including deep venous thrombosis and pulmonary embolism.
Objective To compare the efficacy and safety of intra-articular combined with intravenous administration of tranexamic acid (TXA) with different dosage for reducing blood loss in primary total knee arthroplasty (TKA). Methods Between January 2017 and June 2017, 90 patients suffering from unilateral osteoarthritis who underwent primary TKA were randomly scheduled to three interventions, named groups A, B, and C. Single dosage of TXA via intravenous injection (IV) and different dosages of TXA via intra-articular injection (IA) were utilized in three groups, respectively. All patients in three groups received 1 g TXA IV at 10 minutes preoperatively, and received 1, 2, and 3 g TXA IA diluted in 50 mL saline after wound closure in groups A, B and C, respectively. The age, gender, body mass index, affected side of the knee, grade of osteoarthritis, grade of America Society of Anesthesiologist, preoperative hemoglobin (Hb) concentration, platelet count, preoperative prothrombin time, and activated partial thromboplastin time were not significantly different between groups (P>0.05). The postoperative wound blood drainage, Hb concentration at 1, 3, and 7 days after operation, transfusion rate, and thromboembolic complications were observed. All patients were routinely observed for deep vein thrombosis (DVT) by the color Doppler ultrasonography at 1 week, 1 month, and 3 months after operation, and the symptomatic pulmonary embolism (PE) were observed. Results All patients in three groups were followed up 7-12 months (mean, 8.4 months). There was no significant difference in operation time between groups (P>0.05). The postoperative wound blood drainage was significantly less in groups B and C than that in group A (P<0.05), whereas no significant difference was found between group B and group C (P>0.05). Incision skin necrosis occurred in 1 case of group B and fat liquefaction occurred in 1 case of group C. The other incisions of 3 groups healed by first intention. There was no significant difference in incision complication incidence between groups. The Hb concentration was significantly higher in groups B and C than that in group A at 1, 3, and 7 days after operation (P<0.05). While between group B and group C, the significant difference of Hb concentration only existed at 1 day after operation (P<0.05). The number of patients who got blood transfusion was significantly less in group B (4 cases, 13.3%) and group C (5 cases, 16.7%) than that in group A (9 cases, 30%) (P< 0.05), but no significant difference was found between group B and group C (P>0.05). The result of color Doppler ultrasonography showed that 1 case got DVT in the contralateral calf at 3 weeks in group B. And there was no symptomatic PE in 3 groups. Conclusion Combined administration of IV and IA TXA in a clinically relevant reduction in blood loss was effective and safe in primary TKA, and no thromboembolic complication was observed. The combination of 1 g IV with 2 g IA could be the optional choice.
Objective To evaluate the clinical effectiveness and safety of tranexamic acid (TXA) in arthroscopic rotator cuff repair by meta-analysis. Methods Randomized controlled trials evaluating the clinical effectiveness and safety of TXA use in the perioperative period of arthroscopic rotator cuff repair were identified from the Cochrane Library, PubMed, Embase, VIP Chinese Science and Technology Periodical Database, Chinese National Knowledge Infrastructure, and Wanfang database, with a search time span from the inception of the database to August 2024. Meta-analysis was conducted using RevMan 5.3 software, and mean difference (MD) and risk difference (RD) were used as measures of effect size. Results A total of 7 randomized controlled trials were included. Meta-analysis demonstrated significant differences in good visual clarity [MD=9.10, 95% confidence interval (CI) (4.05, 14.15), P=0.0004] and operative time [MD=−12.07 min, 95%CI (−17.21, −6.93) min, P<0.00001]. There was no significant difference in mean arterial pressure [MD=−1.08 mm Hg (1 mm Hg=0.133 kPa), 95%CI (−3.13, 0.98) mm Hg, P=0.30] or adverse event rate [RD=0.02, 95%CI (−0.01, 0.06), P=0.22] between the two groups. Conclusion TXA is effective and safe in enhancing visual clarity and significantly reducing operative time in arthroscopic rotator cuff repair, without increasing the incidence of adverse 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 effectiveness of haemocoagulase agkistrodon and tranexamic acid and sodium chloride in the prevention and treatment of perioperative bleeding in a real world setting. MethodsA research database was constructed based on the records of inpatient visits using haemocoagulase agkistrodon and tranexamic acid and sodium chloride according to the SuValue® database from January 1, 2016 to December 31, 2020. The patients were divided into two groups according to the different interventions. After matching with a 1∶1 propensity score, the effectiveness of two groups was compared. ResultsA total of 858 patients were included in each of the two groups, and there was no statistically significant difference in baseline characteristics between the two groups (P>0.05). Research results showed that patients using haemocoagulase agkistrodon had significantly reduced length of hospital stay, decrease in hematocrit, average estimated surgical bleeding, and decrease in hemoglobin (P<0.01). ConclusionHaemocoagulase agkistrodon has better effectiveness than tranexamic acid and sodium chloride for reducing perioperative blood loss based on current real world evidence.
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.
ObjectiveTo evaluate the effectiveness and safety of tranexamic acid (TXA) combined with intraoperative controlled hypotension (ICH) for reducing perioperative blood loss in primary total hip arthroplasty (THA).MethodsThe clinical data of 832 patients with initial THA due to osteonecrosis of femoral head between January 2017 and July 2020 were retrospectively analyzed. All patients received TXA treatment, and 439 patients (hypotension group) received ICH treatment with an intraoperative mean arterial pressure (MAP) below 80 mm Hg (1 mm Hg=0.133 kPa) while 393 patients (normotension group) received standard general anesthesia with no special invention on blood pressure. There was no significant difference in age, gender, body mass index, American Society of Anesthesiologists (ASA) classification, basic arterial pressure, hip range of motion, internal diseases, preoperative hemoglobin (HB) and hematocrit (HCT), coagulation function, surgical approach, and TXA dosage between the two groups (P>0.05). The perioperative blood loss and blood transfusion, anesthesia and operation time, hospitalization stay, postoperative range of motion, and complications were recorded and compared between the two groups. The patients were further divided into MAP<70 mm Hg group (group A), MAP 70-80 mm Hg group (group B), and normotension group (group C). The perioperative blood loss and postoperative complications were further analyzed to screen the best range of blood pressure.ResultsThe intraoperative MAP, total blood loss, dominant blood loss, recessive blood loss, blood transfusion rate and blood transfusion volume, anesthesia time, operation time, and hospitalizarion stay in the hypotension group were significantly lower than those in the normotension group (P<0.05). The postoperative hip flexion range of motion in the hypotension group was significantly better than that of the normotension group (Z=2.743, P=0.006), but there was no significant difference in the abduction range of motion between the two groups (Z=0.338, P=0.735). In terms of postoperative complications, the incidence of postoperative hypotension in the hypotension group was significantly higher than that in the normotension group (χ2=6.096, P=0.014), and there was no significant difference in the incidence of other complications (P>0.05). There was no stroke, pulmonary embolism, or deep vein thrombosis in the two groups, and no patients died during hospitalization. Subgroup analysis showed that there was no significant difference in total blood loss, dominant blood loss, and recessive blood loss in groups A and B during the perioperative period (P>0.05), which were significantly lower than those in group C (P<0.05). There was no significant difference in blood transfusion rate, blood transfusion volume, and incidence of acute myocardial injury between 3 groups (P>0.05); the incidence of acute kidney injury in group A was significantly higher than that in group B, and the incidence of postoperative hypotension in group A was significantly higher than that in groups B and C (P<0.05), but no significant difference was found between groups B and C (P>0.05).ConclusionThe combination of TXA and ICH has a synergistic effect. Controlling the intraoperative MAP at 70-80 mm Hg can effectively reduce the perioperative blood loss during the initial THA, and it is not accompanied by postoperative complications.