NCT05053867

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Pulmonary Hemorrhage
• Cancer

Interventions

Type	Name	Description
DRUG	tranexamic acid	Inhaled
OTHER	Usual Care	Standard of Care

Timeline

• Start date: 2022-10-14
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2021-09-23
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study