Randomized prospective evaluation of the use of tranexamic acid and effects on blood loss for proximal humeral fracture surgery

Abstract

Background: Tranexamic acid (TXA) is an antifibrinolytic agent that has been used to reduce blood loss in orthopedic surgery. It has been shown to decrease blood loss in upper- and lower-extremity arthroplasty, as well as lower-extremity fracture surgery. The use of TXA for proximal humeral fracture surgery has yet to be evaluated. The purpose of this study was to examine the effects of TXA on blood loss in patients undergoing open reduction-internal fixation (ORIF) or arthroplasty for the treatment of proximal humeral fractures.

Materials and methods: A total of 101 patients were randomized to receive either a single preoperative dose of intravenous TXA (53 patients) or a control dose of saline solution (48 patients) at the time of proximal humeral fracture surgery. On the basis of patient age and fracture pattern, ORIF was performed in 57 patients (30 TXA and 27 control patients) and reverse shoulder arthroplasty (RSA) was performed in the other 44 patients (23 TXA and 21 control patients). Intraoperative blood loss plus 24-hour drain output was used to calculate total blood loss for each procedure. The preoperative-to-postoperative change in hemoglobin level was also evaluated for each patient. Further stratification of blood loss and change in hemoglobin level based on procedure (ORIF or RSA) was performed as well.

Results: Compared with the control group, the TXA group had less average intraoperative blood loss (178 mL vs. 129 mL, P < .0001), less postoperative drain output (103 mL vs. 62 mL, P < .0001), and less total blood loss (280 mL vs. 188 mL, P < .0001). Compared with the control group, the TXA group had a smaller average preoperative-to-postoperative change in hemoglobin level (-2.6 g/dL vs. -1.5 g/dL, P < .0001). Further stratification based on procedure showed that among patients undergoing ORIF and patients undergoing RSA, those receiving TXA had less average total blood loss and a smaller decrease in hemoglobin level than the control group. No identifiable intraoperative or postoperative complications associated with the use of TXA occurred in any patient.

Conclusion: TXA was effective in reducing total blood loss and led to a smaller preoperative-to-postoperative decrease in hemoglobin level compared with control in patients undergoing surgery for proximal humeral fractures. This effect was consistent in patients treated with either ORIF or arthroplasty as the surgical procedure. TXA can be used to decrease blood loss in the surgical treatment of proximal humeral fractures.

Keywords: ORIF; RSA; TXA; Tranexamic acid; blood loss; open reduction–internal fixation; proximal humeral fracture; reverse shoulder arthroplasty.