Background and Objective
Knee arthroplasty, a major surgical procedure, often results in significant blood loss. The study aimed to evaluate the efficacy and safety of topical administration of 3 g of tranexamic acid (TXA) in reducing blood loss during this surgery.
Material and Method
The trial was a randomized, phase III, double-blind, placebo-controlled clinical study involving 150 patients divided into two parallel treatment groups (75 per arm). TXA was administered topically intra-articularly after cementation and before capsular closure. Blood loss was quantified through analytical determinations before and after surgery.
Results
The placebo group experienced a total blood loss of 831.5 ml, compared to 662.3 ml in the TXA group, marking a significant difference of 169.2 ml (20.4% reduction, p < .001). No significant differences were observed in the onset of ambulation, days of admission, or pain levels one month post-surgery. Ten patients were excluded due to various reasons, including presurgical urinary tract infection and prosthetic instability. Only one complication, unrelated to the investigational drug, was reported.
Conclusion
The study concludes that a single dose of topical TXA administered after the cementation of prosthetic components in total knee arthroplasty is both safe and effective in significantly reducing blood loss.
