A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients

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:

• 100 day, ICU and hospital mortality rate
• Ventilator days at day 30
• ICU and Hospital Length of Stay
• PaO2:FIO2 ratio (or SpO2:FIO2 ratio) changes over the first 14 days
• Time to resolution of pulmonary hemorrhage
• Rate of recurrence of pulmonary hemorrhage
• Rate of invasive procedures required to control pulmonary hemorrhage

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

2.3.2 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