Clinical trial NCT05648656: TXA Nebulization for the Treatment of Hemoptysis
Official title: Efficacy of TXA Nebulization for the Treatment of Hemoptysis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hemoptysis
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2022-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* All cases of active hemoptysis
* irrespective of gender
* age≥ 18 years

Exclusion Criteria:

* Massive hemoptysis
* Pregnancy
* Drug allergy to TXA4
* Renal failure
* Receiving Oral Contraceptive Pills.
* Already on blood thinner
* Not willing for consent.

Primary outcomes:
measure: Frequency of hemoptysis
timeFrame: 48 hours
measure: Quantity of hemoptysis
timeFrame: 48 hours
measure: Visual analogue scale (VAS)
timeFrame: 48 hours
Secondary outcomes:
measure: Adverse drug events
timeFrame: 48 hours
measure: Resolution of hemoptysis
timeFrame: 48 Hours
measure: Need for intervention
timeFrame: 48 Hours
measure: Need for blood transfusion
timeFrame: 48 Hours
measure: Duration of hospital stay
timeFrame: 4 weeks
measure: Mortality
timeFrame: 4 weeks
measure: Recurrence of hemoptysis
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
Study officials:
References: