RecruitingPhase 3NCT05053867

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

60 participants

Start Date

Oct 14, 2022

Study Type

INTERVENTIONAL

Conditions

Cancer Pulmonary Hemorrhage

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Age \> 18 years old
Have a diagnosed hematological malignancy
Are actively receiving mechanical ventilation
Have evidence of pulmonary hemorrhage as defined by either
Persistently bloody secretions upon endotracheal tube suctioning, or
Evidence of diffuse alveolar hemorrhage by bronchoscopic examination
Signed informed consent by patient or if the subject lacks decision-making capacity, the subject's legally authorized representative

Exclusion Criteria15

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