The efficacy and safety of multiple doses of oral tranexamic acid on blood loss, inflammatory and fibrinolysis response following total knee arthroplasty: A randomized controlled trial.

BACKGROUND

The aim of the study was to identify the efficacy and safety of multiple doses of oral tranexamic acid (TXA) on reducing blood loss and minimizing the postoperative inflammatory and fibrinolytic responses following primary total knee arthroplasty (TKA).

MATERIALS AND METHODS

In this prospective, double-blinded, randomized trial, we randomly assigned a total of 151 patients into three groups to receive 2 g of oral TXA 2 h preoperatively (group A); an additional dose of 2 g of oral TXA 4 h postoperatively (group B); or additional doses of 2 g of oral TXA at 4, 10, and 16 h postoperatively (group C). The primary outcome was total blood loss (TBL). The secondary outcomes were maximum drop in hemoglobin (Hb) and hematocrit (Hct), level of inflammatory and fibrinolytic parameters, transfusion rate, and the incidence of complications.

RESULTS

The results were represented as mean ± standard deviation. The mean TBL was 607 ± 254 mL in group C, 743 ± 347 mL in group B (p = 0.027 vs group C), and 978 ± 335 mL in group A (p<0.001 vs group C). The maximum Hb and Hct drop was 18.3 ± 7.7 g/L and 0.051 ± 0.025 in group C, 22.3 ± 9.7 g/L and 0.070 ± 0.028 in group B (p = 0.022 and p = 0.001 vs group C), 29.6 ± 11.7 g/L and 0.090 ± 0.034 in group A (p<0.001 and p<0.001 vs group C). In addition, C-reactive protein and interleukin-6 in group C were lower than in group A (p<0.001 and p = 0.003) and in group B (p = 0.031 and p < 0.001) on postoperative day (POD) 3. Moreover, fibrin degradation products and D-dimer in group C were lower than in groups A and B on both POD 1 and POD 3. The incidence of complications did not differ significantly between the three groups (p > 0.05).

CONCLUSION

Multiple postoperative doses of oral TXA could further reduced blood loss and the drop in Hb and Hct, and diminished the postoperative inflammatory and fibrinolytic responses in primary TKA with no apparent increase in the incidence of complications.

LEVEL OF EVIDENCE

Level Ⅰ, therapeutic study.