A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
Summary
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.
Detailed description
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: 1. 100 day, ICU and hospital mortality rate 2. Ventilator days at day 30 3. ICU and Hospital Length of Stay 4. PaO2:FIO2 ratio (or SpO2:FIO2 ratio) changes over the first 14 days 5. Time to resolution of pulmonary hemorrhage 6. Rate of recurrence of pulmonary hemorrhage 7. Rate of invasive procedures required to control pulmonary hemorrhage
Arms & interventions
- Drugtranexamic acid
Inhaled
- OtherUsual Care
Standard of Care
Outcome measures
Primary
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
Eligibility criteria
Study locations (1)
M D Anderson Cancer Center
Houston, Texas, 77030