Actively Recruiting
A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
Led by M.D. Anderson Cancer Center · Updated on 2026-01-14
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating inhaled tranexamic acid to see if it can reduce death rates in cancer patients experiencing pulmonary hemorrhage and respiratory failure who are receiving mechanical ventilation. This Phase 3 drug study compares inhaled tranexamic acid against usual care, focusing on mortality and other important health outcomes in this critically ill population. Participants will be assigned to receive either nebulized tranexamic acid at a dose of 500 mg in 5 ml every 8 hours for a minimum of 3 days and up to 5 days, or usual care without the study drug. The study specifically targets patients with hematological malignancies who have evidence of pulmonary hemorrhage and require mechanical ventilation. During the study, researchers will monitor participants for 28-day all-cause mortality as the main outcome. Additional outcomes include mortality at 100 days, ventilator use duration, length of stay in ICU and hospital, lung function ratios over 14 days, time to stop bleeding in the lungs, recurrence of hemorrhage, and need for invasive procedures to control bleeding. Participants will be observed closely with standard clinical evaluations throughout their hospital stay.
CONDITIONS
Brief Title
A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- Diagnosed with a hematological malignancy
- Actively receiving mechanical ventilation
- Evidence of pulmonary hemorrhage through bloody secretions or bronchoscopic examination
- Signed informed consent by patient or legally authorized representative
You will not qualify if you...
- Do Not Resuscitate (DNR), no escalation of care, or comfort care order at screening
- Expected survival less than 48 hours
- Nasal or oral spillage causing bloody secretions
- Requirement for 100% FIO2
- Known hypersensitivity to tranexamic acid
- Prior treatment with inhaled tranexamic acid before screening
- Acquired defective color vision
- Subarachnoid hemorrhage
- Deep venous or arterial thrombus diagnosed within past 3 months
- Active seizure disorder on anti-epileptic medication
- Pregnant women or positive pregnancy test
- Concurrent anti-fibrinolytic therapy
- Confirmed active COVID-19 infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 5 days
Participants receive inhaled tranexamic acid every 8 hours for at least 3 days and up to 5 days or usual care as part of the trial.
Daily visits during treatment period
Duration - Up to 28 days
Participants are monitored for outcomes such as mortality and pulmonary hemorrhage recurrence for up to 28 days after treatment.
Regular follow-up visits during 28-day period
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nisha Rathi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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