Oral tranexamic acid for bleeding during spinal surgery: A randomized double-blind placebo clinical trialRunning title: Oral tranexamic acid for spinal surgery

Abstract

Objectives: This study aimed to evaluate the oral Tranexamic acid (TXA) effect on the bleeding during spine surgery amounts. Patients and Methods: In this randomized double-blind placebo clinical trial, patients with lumbar spinal cord and back pain disease, those who needed fusion or were candidates for bilateral or more or equal to two levels surgeries, and those who referred to the Neurosurgery Department, were included and randomly divided into two equal groups. TXA was orally administered at 25 mg/kg dosages four times a day before surgery and 500 mg in the morning of surgery. The bleeding amount during the operation was calculated based on the number of sterile pads used during the operation and the amount of bleeding collected in the suction device (suction) in milliliters. Each sterile pad soaked in blood is equal to 50 ml of bleeding. The suction blood content at the end of the operation (in milliliters), was also collected by bleeding in sterile pads and reported in milliliters . The difference in hemoglobin level 24 after surgery was compared to before surgery. The follow-up period was until discharge from the hospital. Results: No significant difference was seen in the demographic data between the two groups (p < 0.05). Oral TXA had a positive effect on the intraoperative and postoperative bleeding amounts, and hospitalization duration, and it significantly reduced bleeding in the mentioned cases (p < 0.05 in all cases). Moreover, no significant differences were observed in coagulation factors, including PT, INR, and coagulation tests between the two groups, even PTT was increased. Oral TXA increased nausea and vomiting experienced by patients in the intervention group (p < 0.05). Conclusions: Overall, oral TXA significantly reduced the intraoperative and postoperative bleeding, as well as the hospitalization duration in patients undergoing spinal surgery in comparison with the placebo group. Because of its anti-fibrinolytic properties, TXA effectively controlled bleeding. Thus, the intraoperative bleeding amount was decreased with the TXA administration.