A Phase 3 interventional study of tranexamic acid and Usual Care in Pulmonary Hemorrhage and Cancer, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by M.D. Anderson Cancer Center · Phase 3, Interventional, and Treatment
This is a drug study that will examine if inhaled tranexamic acid can improve mortality in patients with cancer-related pulmonary hemorrhage and respiratory failure as compared to usual care.
Primary Objective: To assess the benefit of using nebulized tranexamic acid versus the standard of care on 30 day mortality.
Secondary Objectives: To assess the following outcomes when using nebulized tranexamic acid versus the standard of care:
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Have evidence of pulmonary hemorrhage as defined by either
2.3.2 Exclusion Criteria
Patients excluded from participation in the study if any of the following criteria are met:
will receive 500 mg/5ml nebulized tranexamic acid every 8 hours for at least 3 days, and up to 5 days
Drug: tranexamic acid
usual care
Other: Usual Care
Inhaled
Standard of Care
28 day all-cause mortality rate
Number of patients who are alive at 28 days following randomization. The difference between 28-day mortality rates between treatment arms will be computed along with a 95% confidence interval (CI) using the approximate standard error reported in Fleiss (1981). Logistic regression will be used to estimate the association between 28-day mortality and study covariates of interest.
Time frame: up to 28 days
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M.D. Anderson Cancer Center