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

Launched by M.D. ANDERSON CANCER CENTER · Sep 20, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at whether inhaled tranexamic acid, a medication that helps stop bleeding, can improve survival rates in cancer patients who are experiencing severe lung bleeding and need help breathing. The study will compare the effects of this medication to the usual care that patients receive in these situations. Researchers hope to find out if using this drug can make a difference in how well patients do.

To participate in this trial, patients must be at least 18 years old and have a blood cancer, while also needing mechanical ventilation to help them breathe. They should show signs of lung bleeding, which can be determined by certain medical tests. However, some patients won't be able to participate, such as those who are not expected to survive for more than two days, those with severe bleeding from other causes, or those who are pregnant. If eligible, participants will receive either inhaled tranexamic acid or standard care and will be closely monitored throughout the study. This research aims to provide new insights into treating a serious condition that affects many cancer patients.

Gender

ALL

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