No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
Who this trial is looking for
This trial is looking for cancer patients who are on a breathing machine and have lung bleeding. Participants will receive a treatment to see if it helps improve their condition compared to usual care.
Are You a Good Fit for This Trial?
Rules you outSeizure disorderActive COVID-19
You may be able to join if
I am over 18 years old.
I have a diagnosed blood cancer.
I am currently on mechanical ventilation.
I have signs of lung bleeding.
You may not be able to join if
I have a Do Not Resuscitate order.
My expected survival is less than 48 hours.
I have had a recent nasal or oral bleed.
I need 100% oxygen.
I am allergic to tranexamic acid.
I have taken tranexamic acid before this trial.
I have active seizures that require medication.
I have active COVID-19.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
1. Age \> 18 years old
2. Have a diagnosed hematological malignancy
3. Are actively receiving mechanical ventilation
4. Have evidence of pulmonary hemorrhage as defined by either
1. Persistently bloody secretions upon endotracheal tube suctioning, or
2. Evidence of diffus…
Inclusion Criteria:
1. Age \> 18 years old
2. Have a diagnosed hematological malignancy
3. Are actively receiving mechanical ventilation
4. Have evidence of pulmonary hemorrhage as defined by either
1. Persistently bloody secretions upon endotracheal tube suctioning, or
2. Evidence of diffuse alveolar hemorrhage by bronchoscopic examination
5. Signed informed consent by patient or if the subject lacks decision-making capacity, the subject's legally authorized representative
2.3.2 Exclusion Criteria
Patients excluded from participation in the study if any of the following criteria are met:
1. Presence of a Do Not Resuscitate (DNR), no escalation of care or comfort care order at the time of screening
2. Expected survival \< 48 hours
3. Evidence of nasal or oral spillage likely to be the cause of bloody secretions
4. Patients requiring 100% FIO2
5. Known hypersensitivity to tranexamic acid
6. Treatment with inhaled tranexamic acid prior to screening
7. Acquired defective color vision
8. Subarachnoid hemorrhage
9. Deep Venous or arterial thrombus diagnosed within the previous 3 months
10. Seizure disorder on active anti-epileptic therapies
11. Hypersensitivity to tranexamic acid or any of the ingredients
12. Pregnant women will not be eligible and have a negative pregnancy test prior to entering study
13. Patient receiving concurrent anti-fibrinolytic therapy
14. Confirmed active COVID-19 infection
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