Study design: Literature review and meta-analysis.
Objectives: Single-center series may be underpowered to detect whether high-dose (HD) tranexamic acid (TXA) confers a higher risk of complications. We sought to determine the safety and efficacy of HD TXA as compared to low-dose (LD) or placebo.
Methods: A systematic literature review was performed to find studies where spine surgery patients were given HD TXA (loading dose ≥30 mg/kg). Complication rates were pooled, and meta-analyses performed on outcomes of interest. Articles were evaluated for risk of bias and a strength of evidence assessment was given for each conclusion.
Results: Twenty three studies (n = 2331) were included. The pooled medical complication rate was 3.2% in pediatric patients, 8.2% in adults. Using lower dose TXA or placebo as the reference, meta-analysis showed no difference in medical complications (n = 1,723, OR 1.22 [95% CI, .78 to 1.22]; P = .388; I2 = 0%) or thrombotic events (n = 1158 patients, OR 1.27 [95% CI, .71 to 2.63]; P = .528; I2 = 0%). Compared to LD, HD TXA was associated with less intraoperative blood loss (823 patients, WMD = -285 [95% CI, -564 to -5.90]; P = .0454; I2 = 86%), fewer perioperative transfusions (n = 505, OR .28 [95% CI, .082 to .96]; P = .043; I2 = 76%) and lower perioperative transfusion volumes (n = 434, WMD -227.7 mL [95% CI, -377.3 to -78.02]; P = .0029; I2 = 0%).
Conclusion: Compared to LD TXA or placebo, there is moderate evidence that HD is not associated with an increased risk of medical complications. Compared to LD, there is moderate evidence that HD reduces transfusion requirements. High-Dose TXA can be safely utilized in healthy patients undergoing major spine surgery.
Keywords: complications; dosing; high dose; low dose; spine; tranexamic acid.