Overview
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.
Description
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
Eligibility
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