Efficacy and Safety of Tranexamic Acid in Intertrochanteric Fractures: A Single-Blind Randomized Controlled Trial

Xin-Die Zhou, Yi Zhang, Li-Feng Jiang, Jun-Jie Zhang, Dong Zhou, Li-Dong Wu, Yong Huang, Nan-Wei Xu, Xin-Die Zhou, Yi Zhang, Li-Feng Jiang, Jun-Jie Zhang, Dong Zhou, Li-Dong Wu, Yong Huang, Nan-Wei Xu

Abstract

Objective: To investigate the efficacy and safety of tranexamic acid (TXA) in the reduction of bleeding and the need for transfusion in elderly intertrochanteric fracture patients.

Methods: A total of 100 patients with intertrochanteric fractures undergoing surgery were enrolled and randomly allocated to the TXA group in which patients (75.10 ± 8.27 years old) were treated with 1 g of TXA, or the control group (77.82 ± 6.42 years old) treated with a placebo. Surgery was performed by two senior orthopaedic surgeons from two institutions. The proximal femoral nail antirotation (PFNA) was conducted using the standard procedure. Three outcome measures, including blood loss, transfusion, and complications, were recorded. Blood loss and transfusion were investigated to assess TXA's effectiveness, while complications were investigated to assess TXA's safety. Statistical indicators for blood loss included total, intraoperative, postoperative, and hidden blood loss volumes, calculated by hemoglobin levels, hematocrit levels, and drainage volume. The number and amount of blood transfusions were recorded. Complications associated with surgery, including deep vein thrombosis, pulmonary embolism, wound hematoma, wound infection, cardiovascular and cerebrovascular accidents, and respiratory infections, were also recorded.

Results: All patients were followed up for 1 month after surgery. There were no significant differences in demographic and clinical characteristics between the two groups. The TXA group suffered significantly less total blood loss (563.37 ± 197.51 vs 819.25 ± 273.96 mL, 95% CI: -349.49 to -162.27, P < 0.01), intraoperative blood loss (140.3 ± 80.64 vs 230.5 ± 130.56 mL, 95% CI -132.74 to -47.66, P < 0.01), and hidden blood loss (410.42 ± 178.23 vs 571.19 ± 218.13 mL, 95% CI: -238.85 to -82.69, P < 0.01) than the control group. However, postoperative total blood loss was not significantly different (97.5 ± 20.93 vs 94.7 ± 35.78 mL; P = 0.63). A total of 5 patients from the TXA group and 27 from the control group received packed RBC for postoperative transfusion, but the mean number of transfusion units was not significantly different between groups. Complications including deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic cerebral infarction, hematoma, and infection were observed in both groups, but no significant differences were found.

Conclusions: In intertrochanteric fracture surgery performed using PFNA, intravenous administration of TXA significantly reduced the risk of intraoperative, total and hidden blood loss, in addition to the need for allogeneic transfusion, without increasing the rate of complications.

Keywords: Blood loss; Intertrochanteric fracture; Randomized controlled trial; Tranexamic acid; Transfusion.

© 2019 The Authors. Orthopaedic Surgery published by Chinese Orthopaedic Association and John Wiley & Sons Australia, Ltd.

Figures

Figure 1
Figure 1
Flow chart of patient enrollment and Consolidated Standards of Reporting Trials (CONSORT).
Figure 2
Figure 2
Preoperative X‐rays (A1, B1, C1) and CT scans (A2, B2, C2) of femoral intertrochanteric fracture from three patients ((A) 77‐year‐old female; (B) 84‐year‐old female; (C) 78‐year‐old male), and which had been treated by closed reduction and internal fixation with PFNA (A3, A4, B3, B4, C3, C4).

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