Nebulized vs IV Tranexamic Acid for Hemoptysis: A Pilot Randomized Controlled Trial

Abstract

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. Does the nebulized route of TA administration reduce the amount of hemoptysis compared with the IV route in patients presenting to the ED with hemoptysis? This was a pragmatic, open-label, randomized, parallel, single-center, pilot trial of nebulized TA (500mg tid) vsIV TA (500mg tid) in adult patients presenting to the ED with active hemoptysis. The primary outcome was cessation of bleeding at 30 min. Secondary outcomes included amount of hemoptysis at 6, 12, 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. Of the 55 patients in each arm, hemoptysis cessation at 30min following TA administration was significantly higher in the nebulization arm (n= 40) compared with the IV arm (n= 28): χ2 (1, n= 110)= 5.55; P= .0019. Also, hemoptysis amount was reduced significantly in the nebulization arm at all time periods of observation (P value at 30 min= .011, at 6 h= .002, 12 h= .0008, and at 24 h= .005). Fewer patients in the nebulization arm required bronchial artery embolization (13 vs21; P= .024) and thereby had higher discharge rates from the ED (67.92%vs39.02%; P= .005). Two patients in the nebulization arm had asymptomatic bronchoconstriction that resolved after short-acting beta-agonist nebulization. No patient discharged from the ED underwent any interventional procedure or revisited the ED with rebleed during the 72h follow-up period. Nebulized TA may be more efficacious than IV 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 with IV TA in patients with mild hemoptysis. Clinical Trials Registry-India; No.: CTRI/2019/05/019337; URL: http://ctri.nic.in/Clinicaltrials/advancesearchmain.php.