Intravenous and Oral Tranexamic Acid are Equivalent at Reducing Blood Loss in Thoracolumbar Spinal Fusion: A Prospective Randomized Trial Phase 2

Intravenous and oral tranexamic acid are equivalent at reducing blood loss in thoracolumbar spinal fusion: a prospective randomized trial.
Discussion and Conclusion: Patients treated with IV and PO TXA experienced the same perioperative blood loss after spinal fusions. Given its lower cost, PO TXA represents an excellent alternative to IV TXA in patients undergoing elective posterior thoracolumbar fusion and may improve healthcare cost-efficiency in the studied population.
Results: 91 patients received IV TXA and 80 patients received PO TXA. Patient demographic factors were similar between groups except for Age, Weight, and BMI. The mean reduction of hemoglobin was similar between IV and PO groups (3.48 g/dL vs. 3.19 g/dL, respectively; P = 0.004, equivalence). Similarly, the calculated blood loss was equivalent (1274 mL vs. 1206 mL, respectively; P = 0.001 equivalence). In addition, higher ASA (American Society of Anesthesiologists) level and longer surgical time were associated with more hemoglobin reduction (P = 0.01 and P
Methods: A prospective randomized trial of patients enrolled at a university affiliated tertiary medical center between February 2017 and October 2018. 171 patients undergoing thoracolumbar fusion were randomized to receive 1.95g of PO TXA 2 hours preoperatively or 2g IV TXA (1g before incision and 1g before wound closure) intraoperatively. The sample was further stratified into 3 categories based on number of levels fused (1-2 level fusions, 3-5, and >5). The primary outcome was the reduction of hemoglobin. Secondary outcomes included calculated blood loss, drain output, postoperative transfusion, complications, and length of hospital stay. Equivalence analysis was performed with a two one-sided test (TOST). A P-value of