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

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Tranexamic Acid

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