A double-blind pilot randomized controlled trial of topical tranexamic acid after sinus surgery

Background: There has been limited study of topical tranexamic acid (TXA) in endoscopic sinus surgery (ESS). We report a pilot study, examining the effects of topical TXA with regards to recovery after ESS. Methods: A pilot double-blind randomized controlled trial was conducted in 30 patients undergoing comprehensive ESS. Patients received either topical TXA or normal saline (NS) for 60 minutes via cotton pledgets at the conclusion of ESS. Patients were followed-up for a duration of 3-months. Results: The mean (95% CI) reduction in 22-item Sino-Nasal Outcome Test (SNOT-22) score at 3 months was 39.5/110 (26.9, 52.0) for TXA and 33.4/110 (24.0, 42.9) for NS (p=0.42). The mean (SD) Modified Lund-Mackay Post-operative Endoscopic (MLMES) score at 3 months was 7.79/100 ±7.70 for TXA and 10.9/100 ±9.35 for NS (p=0.12). TXA had a mean (SD) bleeding score of 4.0 ± 2.33 on day 1 compared to 3.64 ± 2.76 in NS group when measured on a Likert scale (p = 0.89). The mean self-reported time to return to work was 4.67 ± 2.22 days for TXA and 6.87 ± 4.42 for NS (p=0.10). Zero cases of confirmed thromboembolism were seen. Conclusions: Although statistically non-significant differences were observed, data from this pilot study imply that there is merit in a larger study to further assess the effects of topical TXA following ESS. There may be a role for increasing the exposure to topical TXA via a different formulation.