Topical administration of tranexamic acid in elderly patients undergoing short femoral nailing for intertrochanteric fracture: A randomised controlled trial

Abstract

Introduction: Topical application of tranexamic acid (TXA) has been proposed as an alternative to intravenous administration to reduce perioperative bleeding in orthopaedic surgery. The purpose of this randomised controlled trial was to evaluate the efficacy and safety of 1 g topically applied TXA in patients undergoing fixation of intertrochanteric hip fractures by short femoral nailing.

Methods: A total of 121 patients were enrolled between May 2018 and January 2020. Patients were randomly allocated (1:1) to receive either 10 mL (1 g) of TXA or 10 mL of normal saline (NS) injected through the subfascial drain following wound closure. Total blood loss, total drain output and blood transfusion requirements up to postoperative day 3 were recorded. Rates of thromboembolic complications and mortality up to 90 days postoperatively were also compared.

Results: There was no statistically significant difference in total blood loss, total drain output or proportion of patients requiring transfusions. Median total blood loss was 1.088 L (IQR: 0.760-1.795) in the TXA group and 1.078 L (IQR: 0.797-1.722) in the NS group (P = .703). Median total drain output was 60 mL (IQR: 40-140) in the TXA group and 70 mL (IQR: 30-168) in the NS group (P = .696). Blood transfusions were administered in 29 patients (47.5%) in the TXA group and 27 patients (45.0%) in the NS group (P = .782). There was also no difference in frequency of thrombotic complications or mortality within 90 days. There were five thrombotic events in the TXA group and four in the NS group (P = .751). The 90-day mortality rate was 6.6% (4 patients) in the TXA group and 3.3% (2 patients) in the NS group (P = .680).

Conclusion: A 1 g dose of topically administered TXA did not produce any difference in blood loss, transfusion requirements, thromboembolic complications, or 90-day mortality. Future trials may consider the effect of larger doses in patients undergoing hip fracture fixation surgery.

Keywords: Blood transfusion; Haemostasis; Hip fracture surgery; Local administration; Perioperative blood loss; Thrombotic events; Trochanteric fracture.