Using inhaled tranexamic acid to treat lung bleeding in cancer patients

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

This study is testing if inhaled tranexamic acid can help cancer patients with lung bleeding live longer and feel better compared to standard care.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05053867 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of nebulized tranexamic acid in reducing mortality rates in cancer patients experiencing pulmonary hemorrhage and respiratory failure compared to standard care. The primary objective is to evaluate the impact of this treatment on 30-day mortality, while secondary objectives include assessing ICU and hospital mortality rates, ventilator days, length of stay, and other related outcomes. Participants will be closely monitored for changes in their condition over a 14-day period, focusing on the resolution of pulmonary hemorrhage and the need for invasive procedures.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a diagnosed hematological malignancy who are on mechanical ventilation and show evidence of pulmonary hemorrhage.

Not a fit: Patients with a Do Not Resuscitate order, expected survival of less than 48 hours, or known hypersensitivity to tranexamic acid may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality rates in cancer patients suffering from pulmonary hemorrhage.

How similar studies have performed: While the use of tranexamic acid has been explored in various contexts, this specific application for pulmonary hemorrhage in cancer patients is novel and has not been extensively tested.

Eligibility criteria

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 met:

1. Presence of a Do Not Resuscitate (DNR), no escalation of care or comfort care order at the time of screening
2. Expected survival \< 48 hours
3. Evidence of nasal or oral spillage likely to be the cause of bloody secretions
4. Patients requiring 100% FIO2
5. Known hypersensitivity to tranexamic acid
6. Treatment with inhaled tranexamic acid prior to screening
7. Acquired defective color vision
8. Subarachnoid hemorrhage
9. Deep Venous or arterial thrombus diagnosed within the previous 3 months
10. Seizure disorder on active anti-epileptic therapies
11. Hypersensitivity to tranexamic acid or any of the ingredients
12. Pregnant women will not be eligible and have a negative pregnancy test prior to entering study
13. Patient receiving concurrent anti-fibrinolytic therapy
14. Confirmed active COVID-19 infection

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Nisha Rathi, MD — M.D. Anderson Cancer Center
• Study coordinator: Nisha Rathi, MD

Conditions Pulmonary Hemorrhage; Cancer