Using inhaled tranexamic acid to treat lung bleeding in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: nrathi@mdanderson.org
• Phone: 713-745-5787

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.