A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
M.D. Anderson Cancer Center
Summary
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: 1. 100 day, ICU and hospital mortality rate 2. Ventilator days at day 30 3. ICU and Hospital Length of Stay 4. PaO2:FIO2 ratio (or SpO2:FIO2 ratio) changes over the first 14 days 5. Time to resolution of pulmonary hemorrhage 6. Rate of recurrence of pulmonary hemorrhage 7. Rate of invasive procedures required to control pulmonary hemorrhage
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Drugtranexamic acid
Inhaled
- OtherUsual Care
Standard of Care
Location
- M D Anderson Cancer CenterHouston, Texas