Efficacy and safety of multiple-dose intravenous tranexamic acid for reducing blood loss in complex tibial plateau fractures: A prospective randomized controlled trial / 中国修复重建外科杂志

OBJECTIVE@#To 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.@*METHODS@#A 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.

Modified knee spreader combined with minimally invasive percutaneous plate internal fixation for complex tibial plateau fractures / 中国组织工程研究

BACKGROUND: Studies have shown that the adjuvant use of long bone distraction device for unstable tibial plateau fractures achieved satisfactory results, but the safety of its use of long bone distraction device is not high, and the device could easily lead to soft tissue damage. OBJECTIVE: To compare the clinical efficacy of modified knee joint spreader combined with minimally invasive percutaneous plate internal fixation and traditional incision reduction plate internal fixation for the treatment of complex tibial plateau fractures. METHODS: A total of 71 patients with complicated tibial plateau fractures admitted to Xiangdong Hospital Affiliated to Hunan Normal University from January 2016 to January 2018 were included, including 48 males and 23 females. The 34 patients in the experimental group received modified knee spreaders combined with minimally invasive percutaneous plate internal fixation treatment. The 37 patients in the control group received traditional open reduction and plate internal fixation. The incision length, operation time, intraoperative blood loss, hospital stay, the time of fracture healing and the incidence of postoperative complications were compared between the two groups. Knee HSS scores were assessed at 1 month and at the last follow-up. The trial was approved by the Ethics Committee of Xiangdong Hospital Affiliated to Hunan Normal University. RESULTS AND CONCLUSION: (1) The operation time, intraoperative blood loss, incision length, and hospital stay were shorter in the experimental group than in the control group (P 0.05). (2) One case of joint stiffness and one case of traumatic arthritis were found in the experimental group. One case of postoperative infection, five cases of joint stiffness, one case of traumatic arthritis and one case of loosening of the internal fixation were found in the control group. The incidence of complications in the experimental group was less than that in the control group (P 0.05). (4) The results showed that compared with the traditional open reduction and internal fixation, the modified knee spreader combined with minimally invasive percutaneous plate internal fixation for complex tibial plateau fractures can improve the operation efficiency, reduce surgical trauma, reduce the incidence of postoperative complications, and shorten hospital stay for patients.