Abstract
PURPOSE: To evaluate the efficacy and safety of intravenous tranexamic acid (TXA) in patients undergoing percutaneous kyphoplasty (PKP), and identify the factors influencing hidden blood loss (HBL). METHODS: This randomized, placebo-controlled trial included 146 patients undergoing PKP surgery from September 2023 to July 2024. Patients were randomly assigned into the TXA group (75 patients received 1.0 g/100mL TXA intravenously) and the placebo group (71 patients received 100mL of normal saline intravenously). Demographic and clinical characteristics were comparable between groups. HBL was calculated and compared on postoperative days 1 (POD1) and 3 (POD3). Visual analog scale (VAS) scores were also recorded preoperatively and during the follow-up. Multivariate logical regression analysis identified independent risk factors for HBL. RESULTS: The HBL in the TXA group was 183.78±115.48mL on POD 1 and 240.65±114.73mL on POD 3, which was significantly lower than the placebo group at 251.30±235.58mL on POD1 (P=0.032) and 384.94±223.18mL on POD3 (P<0.001). The drop in hemoglobin in the TXA group was generally lower than that of the placebo group on POD1 (4.72±3.54 vs 7.62±8.38 g/L, P=0.007), but showed no significant difference on POD 3. The drop in hematocrit in the TXA group was significantly lower than that in the placebo group on POD1 (1.91±1.21% vs 2.65±2.42%, P=0.023) and POD3 (2.49±1.23% vs 3.92±2.09%, P<0.001). Additionally, the VAS scores on POD1 (2.28±0.88 vs 2.82±0.98, P<0.001) and POD3 (1.95±0.75 vs 2.25±0.69, P=0.011) were lower in the TXA group than in the placebo group. Multivariate logical regression analysis revealed that the use of TXA (P<0.001), injury time (P<0.001), number of punctures (P=0.004), cement leakage (P=0.001), and restoration of vertebral height (P=0.002) were significantly correlated with HBL. CONCLUSION: A single of 1g dose of intravenous TXA reduces HBL and early postoperative pain in PKP patients without increasing the complication rate. The use of TXA, injury time, number of punctures, cement leakage, and restoration of vertebral height were risk factors for HBL in PKP surgery. (ChiCTR2300075428).