201. Prospective randomized controlled trial of tranexamic acid use during elective lumbar spine surgery, preliminary results

Abstract

BACKGROUND CONTEXT Current literature demonstrates that tranexamic acid (TXA) use during spine surgery is safe and effective at reducing intraoperative blood loss and need for blood transfusion. TXA use is increasing and it is now being used in both major and minor spine procedures. Literature comparing the use of topical TXA and intravenous (IV) TXA in reducing blood loss and transfusion rates in elective lumbar spine procedures is scarce. PURPOSE This study aimed to compare the efficacy of topical and IV TXA in reducing intraoperative and postoperative blood loss in adult patients undergoing elective lumbar spine surgery. STUDY DESIGN/SETTING Prospective randomized controlled trial at a single tertiary academic center. PATIENT SAMPLE This is a preliminary report on 125 prospectively enrolled patients who underwent elective decompressive lumbar laminectomy of one to four levels, with or without lumbar fusion. In total, 195 patients will be enrolled; we currently are presenting data from the 125 patients who have completed the protocol to date. OUTCOME MEASURES Primary outcomes included intraoperative estimated blood loss, perioperative change in hemoglobin / hematocrit, transfusion rates, and postoperative drain output. Secondary outcomes included operative and anesthesia time, hospital length of stay (LOS), postoperative complications including venous thromboembolism and infection, and postoperative visual analog scale (VAS) pain scores with morphine milligram equivalents (MME) per day. METHODS A total of 125 patients were randomized preoperatively into one of three treatment arms: control (n=34), topical TXA (n=35), or IV TXA (n=56). The control group received normal saline and did not receive either topical or IV TXA. The topical TXA group received 3g TXA diluted in 250ml of normal saline, which bathed the surgical site undisturbed for 2 minutes prior to wound closure. The IV TXA group received a 10 mg/kg bolus prior to incision followed by a second 10mg/kg dose three hours after the initial dose. The primary and secondary outcome measures were compared between the three groups. Descriptive, ANOVA, chi-squared, and multiple logarithmic regression analysis were utilized. RESULTS No differences were found between the control, IV TXA, and topical TXA groups in intraoperative estimated blood loss (211.2 ± 152.5ml vs 157.1 ± 119.2ml vs 175.6 ± 153ml, p=0.207), postoperative change in hematocrit (7.7 ± 2.9 vs 6.2 ± 3.2 vs 7.0 ± 2.9, p=0.176), and blood transfusion rates (2.9% vs 3.6% vs 0%, p=.5496). Patients who received IV TXA and topical TXA both had significantly less drain output on postoperative day 1 (POD1) than the control group (172 ± 98.2ml vs 72.8 ± 52.9ml vs 52.0 ± 50.0ml, p=0.0001); however, there was no difference in POD1 drain output between the IV and topical groups (p=0.089). There was a decreased risk of requiring pain medication in oral morphine equivalents in the IV and topical TXA groups compared to controls. There were no significant differences in LOS, operative and anesthesia time, pain scores, and postoperative complications. CONCLUSIONS There were significant decreases in POD1 drain output and pain medication requirements in IV and topical TXA patients, when compared to controls, in adult elective lumbar spine patients. There were no observed differences between intraoperative blood loss, postoperative change in hematocrit, or transfusion rates. There were no major TXA-related complications. FDA DEVICE/DRUG STATUS Tranexamic acid (Approved for this indication).