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

Description

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.

Conditions

Pulmonary Hemorrhage, Cancer

Study Overview

Study Details

Study overview

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.

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

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

Condition
Pulmonary Hemorrhage
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Nisha Rathi, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2025-07-31