A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
Recruiting · NCT05053867 · Interventional (participants receive a specific treatment) · Lead sponsor: M.D. Anderson Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Usual Caretranexamic acid
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
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
1 location listed across 1 US state.
- M D Anderson Cancer Center - Houston, Texas, United States