Tranexamic acid and tourniquet versus tourniquet for controlling blood loss during open abdominal myomectomy: a double-blind placebo-controlled randomised trial

Abstract

Objectives To compare blood loss in reproductive-age women who received intravenous tranexamic acid plus tourniquet versus tourniquet and placebo during an open abdominal myomectomy. Methods This is a prospective three-centre double-blind randomised placebo-controlled trial of consenting eligible 114 women with uterine fibroids scheduled for open abdominal myomectomy. The participants were randomised equally (ratio of 1:1) to receive either 1 g of intravenous tranexamic acid plus tourniquet (study group) or tourniquet plus placebo (control group) during the procedure. The primary outcome measure was the volume of intraoperative blood loss in both groups, while the secondary outcome measures were the mean volume of total blood loss, the mean difference between preoperative and postoperative haemoglobin, and the rate of intraoperative and postoperative blood transfusion in both groups. Results The demographic characteristics of the participants enrolled in this trial were homogenous at baseline, and there was no significant difference in the mean intraoperative blood loss between the study and control groups (578.53±142.59 mL vs 629.35±174.13 mL; p=0.09). The mean total blood loss (1016.30±233.4 mL vs 1128.47±282.85; p=0.02), the rate of intraoperative (5.3% vs 33.3%, p<0.01) and postoperative (1.8% vs 22.8%, p=0.01) blood transfusions, respectively, were significantly lower in the study group than the control group. However, the mean difference in haemoglobin concentration was significantly higher in the study group than in the control group (1.97±0.47 g/dL vs 2.49±0.73 g/dL; p<0.01). Conclusion Intraoperative tranexamic acid as an adjunct to a tourniquet is associated with a significant reduction in both the mean total blood loss and the necessity for blood transfusions during open abdominal myomectomy procedures. Trial registration number PACTR202312679640849.