Efficacy and safety of tranexamic acid nebulization to control bleeding of hemoptysis: The TXA-NEB randomized controlled clinical trial

Abstract: OBJECTIVES: The objective of this study was to evaluate the efficacy and safety of tranexamic acid (TXA) nebulization to control bleeding in hemoptysis. MATERIALS AND METHODS: In this randomized controlled clinical trial, 27 participants with hemoptysis received nebulization with TXA (500 mg/5 mL, q 8 hourly for 2 days), and 29 participants with hemoptysis received nebulization with 0.9% normal saline (5 mL, q 8 hourly for 2 days) along with the standard therapy and followed up for 8 weeks. RESULTS: The mean percentage decrease in the frequency (63.9% vs. 39.8%, P = 0.012) and quantity (73.4% vs. 51.7%, P = 0.024) of hemoptysis was significantly higher in the TXA group compared to the control group at day 1 but was insignificant at day 2. However, after excluding participants who underwent intervention ( N = 11), the improvement in frequency (76.2% vs. 50.3%, P = 0.049) and quantity (85.2% vs. 58.6%, P = 0.021) of hemoptysis was significantly better in the TXA group even at day 2. Out of 56 participants, 24 participants achieved resolution of hemoptysis, which was also significantly ( P = 0.003) better in the TXA group (63.0%) compared to the control group (24.1%). No serious adverse drug reaction was observed. Minor cough (37.5%) and throat irritation (33.9%) were observed, which were comparable ( P = 0.432) between the groups. CONCLUSION: TXA nebulization, an alternative route of administration, was found to be safe. Prompt nebulization with TXA was effective as bridging therapy in hemoptysis to achieve the immediate goal of bleeding control before definitive intervention planned or performed. Further studies are encouraged to evaluate this novel approach of TXA nebulization. Trial registration: clinicaltrials.gov PRS ID: NCT05648656.