Hemoptysis is a common presentation in medical emergency. Prompt medical therapy,
bronchoscopic and endovascular procedures remains the cornerstone of management for both
diagnostic as well as therapeutic purpose in hemoptysis. Priority is given for medical
management to achieve hemostasis and prevent aspiration as well as treatment of underlying
etiology, before undertaking any definitive bronchoscopic or endovascular intervention. While
majority of the patients are managed successfully by prompt medical therapy, only the
refractory cases and life-threatening hemoptysis need more definitive procedures like DSA
guided bronchial artery embolization and bronchoscopic procedures like endobronchial
biocompatible glue, endobronchial embolization using silicone spigots, endobronchial stents,
laser photocoagulation. Tranexamic acid is an anti-fibrinolytic agent which prevent breakdown
of fibrin clots, thus helping in clot stabilization and controlling bleeding. As a medical
therapy Tranexamic Acid is used for bleeding control in hemoptysis as well as other surgical
or traumatic bleeding. Previously conducted institutional study comparing IV infusion of TXA
to placebo in patients with sub massive hemoptysis showed results favoring TXA over placebo
in terms of decreasing frequency & quantity of hemoptysis, duration of hospital stay and need
for DSA/ broncoscopic/ surgical intervention and blood transfusion (1). While the oral and IV
routes have been most commonly studied, use of novel approaches like aerosolized TXA and
endobronchial instillation of TXA during bronchoscopy have showed positive results in
achieving hemostasis in hemoptysis (2). A recently conducted RCT, to assess the effectiveness
of TXA nebulization in sub-massive hemoptysis concluded that nebulized TXA is effective in
reducing the frequency and quantity of hemoptysis. Nebulized TXA was also found to be safe as
no severe ADR was noted during its use as per previous RCT as well as multiple case reports.
However, because of limited number of research with small sample size and barring some case
reports evidence for the use of nebulized TXA is limited in hemoptysis. In hemoptysis
nebulized form of TXA is supposed to reach local site of bleeding (lung/ airway) promptly at
a higher concentration leading to rapid control of hemoptysis. So, this study has been
planned to evaluate further this novel approach of TXA nebulization for the management of
hemoptysis. Similarly, data regarding adverse drug reaction related to TXA nebulization is
also limited. This study will produce additional information regarding efficacy, safety and
ADR related to TXA nebulization.
Phase:
Phase 3
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research