Inhaled tranexamic acid as a treatment option in nonmassive hemoptysis: a randomized controlled trial

Abstract

Background
Hemoptysis is a potentially life-threatening condition with variable etiology and severity. Tranexamic acid (TXA), an antifibrinolytic agent, has demonstrated efficacy in bleeding control. Nebulized TXA offers targeted pulmonary delivery with reduced systemic exposure, but clinical evidence remains limited.


Objectives
To evaluate the efficacy and safety of nebulized TXA in patients with nonmassive hemoptysis.


Patients and methods
This randomized, double-blind, placebo-controlled trial was conducted at Mansoura University Hospitals. Adult patients with nonmassive hemoptysis were randomized to receive either nebulized TXA (500 mg in 5 ml normal saline, three times daily) or nebulized placebo (normal saline). The primary outcome was hemoptysis cessation within 5 days. Secondary outcomes included length of hospital stay, recurrence rate within 3 months, and need for interventional procedures. Data were analysed using appropriate statistical tests, including logistic and linear regression to adjust for confounders.


Results

A total of 114 patients were enrolled (study group:
n
=36; control group:
n
=78). Both groups were comparable in baseline demographic and clinical characteristics. The mean time to hemoptysis cessation was significantly shorter in the TXA group compared with the control group (2.1±0.95 vs. 6.36±3.06 days;
P
<0.001). Hemoptysis recurrence was significantly lower in the TXA group (11.1%) versus the control group (66.7%;
P
<0.001). Multivariate logistic regression demonstrated that nebulized TXA significantly reduced the odds of recurrence (OR: 0.026;
P
=0.003). Linear regression showed that TXA use significantly shortened the time to cessation (β=−4.088;
P
<0.001). No serious adverse events were reported.



Conclusion
Nebulized TXA is a safe and effective therapeutic option for nonmassive hemoptysis, significantly reducing both the time to bleeding cessation and recurrence rates. This targeted, noninvasive approach offers a promising first-line therapy, though further large-scale trials are warranted to confirm these findings and optimize treatment protocols.