The effectiveness of low-dose and high-dose tranexamic acid in posterior lumbar interbody fusion: a double-blinded, placebo-controlled randomized study.

Abstract

Tranexamic acid is a proven drug used for reduction of intraoperative blood loss in spinal surgery. However, optimal dosing considering risk/benefits is not well established owing to the heterogeneity in patient selection and surgical procedures of previous studies. This study aimed to evaluate the effectiveness and safety of various tranexamic acid regimens in reducing perioperative blood loss in single-level posterior lumbar interbody fusion (PLIF). Patients were randomly grouped into three different interventions: low-dose tranexamic acid (LD), high-dose tranexamic acid (HD), and placebo-controlled (PC) groups. The HD and LD groups received 10 and 5mg/kg of bolus loading dose and 2 and 1mg/kg of continuous infusion until 5h after surgery, respectively. Data on patient demographics and preoperative and 24-h postoperative laboratory values were collected. Outcome parameters include intraoperative blood loss, 24-h postoperative blood loss, and blood loss during removal of the last drain. Seventy-two patients (mean age 63.3±7.6years) showed similar baseline characteristics. Intraoperatively, blood loss was reduced by the administration of tranexamic acid (P=0.04), contributed predominantly by a difference between the LD and HD groups (123mL; P<0.01). The 24-h postoperative blood loss was reduced (P<0.01), contributed predominantly by a difference between the PC and LD groups (144mL; P=0.02). During the removal of the last drain, statistical difference was found between the PC and HD groups (125mL; P=0.00). No complications or side effects from tranexamic acid use were noted. Tranexamic acid administration for single-level PLIF was effective and safe in reducing perioperative blood loss in a dose-dependent manner. An HD regimen comprising 10mg/kg of bolus loading dose and 2mg/kg/h of continuous infusion is recommended. Level 1 study according to Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence.