A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
Recruiting now · Phase 3
Conditions studied: Pulmonary Hemorrhage, Cancer
In brief
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.
Key facts
- Study ID
- NCT05053867
- Run by
- M.D. Anderson Cancer Center
- People needed
- 60
- Starts
- 2022-10-14
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-07-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years old
- Have a diagnosed hematological malignancy
- Are actively receiving mechanical ventilation
- Have evidence of pulmonary hemorrhage as defined by either
- Persistently bloody secretions upon endotracheal tube suctioning, or
- Evidence of diffuse alveolar hemorrhage by bronchoscopic examination
- Signed informed consent by patient or if the subject lacks decision-making capacity, the subject's legally authorized representative
- 3.2 Exclusion Criteria
- Patients excluded from participation in the study if any of the following criteria are met:
- Presence of a Do Not Resuscitate (DNR), no escalation of care or comfort care order at the time of screening
- Expected survival < 48 hours
- Evidence of nasal or oral spillage likely to be the cause of bloody secretions
- Patients requiring 100% FIO2
- Known hypersensitivity to tranexamic acid
- Treatment with inhaled tranexamic acid prior to screening
- Acquired defective color vision
- Subarachnoid hemorrhage
- Deep Venous or arterial thrombus diagnosed within the previous 3 months
- Seizure disorder on active anti-epileptic therapies
- Hypersensitivity to tranexamic acid or any of the ingredients
- Pregnant women will not be eligible and have a negative pregnancy test prior to entering study
- Patient receiving concurrent anti-fibrinolytic therapy
- Confirmed active COVID-19 infection
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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