Nebulized versus intravenous tranexamic acid for hemoptysis: A pilot randomized controlled trial.

BACKGROUND: Tranexamic acid (TA) is used to control bleeding in patients with hemoptysis. However, the effectiveness of the different routes of TA administration has not been studied.

RESEARCH QUESTION: Does nebulized route of Tranexamic Acid (TA) administration reduce the amount of hemoptysis compared to intravenous route in patients presenting to emergency department (ED) with hemoptysis?

METHODS: We conducted a pragmatic, open labelled, cluster randomized, parallel single centered pilot trial of nebulized TA (500mg tid) versus intravenous TA (500mg tid) in adult patients presenting to emergency department with active hemoptysis. The primary outcome was cessation of bleeding at 30 min. Secondary outcome included amount of hemoptysis at 6h, 12h and 24 h; interventional procedures and side effects of TA. Patients who were hemodynamically unstable or requiring immediate interventional procedure or mechanical ventilation were excluded from the study.

RESULTS: Of the 55 patients in each arm, hemoptysis cessation at 30 minutes after TA administration was significantly higher in nebulized arm (n=40) compared to intravenous arm (n=28) [X2 (1, n=110)=5.55, p=0.0019]. Also, hemoptysis amount reduced significantly in nebulization arm at all time periods of observation (P value 30min=0.011, at 6h=0.002, 12h=0.0008, 24h=0.005). Fewer patients in nebulized arm required bronchial artery embolization (13 vs 21, P value=0.024) and thereby higher discharge rates from the ED (67.92% vs 39.02%, P value=0.005). Two patients in nebulized arm had asymptomatic bronchoconstriction which resolved after short acting beta agonist nebulization. No patient discharged from ED underwent any interventional procedure or revisited the ED with rebleed during the 72 hours follow up period.

INTERPRETATION: Nebulized TA may be more efficacious than intravenous TA in reducing the amount of hemoptysis and need for ED interventional procedures. Future larger studies are needed to further explore the potential of nebulized TA compared to intravenous TA in patients with mild hemoptysis.