Intravenous and Oral Tranexamic Acid Are Equivalent at Reducing Blood Loss in Thoracolumbar Spinal Fusion: A Prospective Randomized Trial Phase II
Yu CC, Fidai MS, Kadri O, Kadado AA, and Bartol S. Intravenous and Oral Tranexamic Acid Are Equivalent at Reducing Blood Loss in Thoracolumbar Spinal Fusion: A Prospective Randomized Trial Phase II. Spine J 2019; 19(9):S108-S109.
BACKGROUND CONTEXT: The use of antifibrinolytic agents such as tranexamic acid (TXA) to decrease operative blood loss and allogenic blood transfusions is well documented in the literature. While evidence supports the use of intravenous (IV) and topical formulations of TXA in spine surgery, the use of oral (PO) TXA has not been studied. PURPOSE: The objective of the study is to compare perioperative blood loss in patients undergoing elective posterior thoracolumbar fusion who were treated with IV vs PO TXA. STUDY DESIGN/SETTING: A prospective randomized trial of patients enrolled at a university affiliated tertiary medical center between February 2017 and October 2018. PATIENT SAMPLE: Enrolled patients were randomly assigned between the 2 treatment groups of IV and oral TXA using a random number algorithm. 90 patients received IV TXA and 81 patients received PO TXA. OUTCOME MEASURES: The primary outcome was the reduction of hemoglobin. Secondary outcomes included calculated blood loss, drain output, postoperative transfusion, complications, and length of hospital stay. METHODS: A total of 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). Equivalence analysis was performed with a two one-sided test (TOST). A P-value of <0.05 suggested equivalence between treatments. RESULTS: 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). A total of 21 patients (23%) in IV TXA group received a transfusion compared with 10 patients in PO TXA group (13%) (P = 0.07). Two patients (2% and 3% in IV and PO, respectively) in each group experienced a DVT/PE (P = 0.90). CONCLUSIONS: 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 health care cost-efficiency in the studied population. FDA DEVICE/DRUG STATUS: Unavailable from authors at time of publication.