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RecruitingPhase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether breathing in tranexamic acid helps more patients survive than usual care. It is for adults with blood cancer, bleeding in the lungs, and breathing failure who are using a breathing machine.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 18.
  • You have been diagnosed with a blood cancer.
  • You are using a breathing machine.
  • You have ongoing bloody mucus when your breathing tube is suctioned, or a camera exam shows bleeding in the lungs' air sacs.
  • You sign a consent form. If you cannot make this decision, your legally authorized representative may sign.

Who can't join

  • You have an order not to restart your heart or breathing, not to increase care, or to give comfort care only; or you are expected to live less than 48 hours.
  • Blood from your nose or mouth likely explains the bloody mucus, or you need 100% oxygen.
  • You are allergic to tranexamic acid or its ingredients, or you received inhaled tranexamic acid before screening.
  • You have developed trouble seeing colors, or you have bleeding in the space around your brain.
  • You had a clot in a deep vein or an artery diagnosed in the past 3 months.
  • You have a seizure disorder and are taking medicine for it.
  • You are pregnant. A negative pregnancy test is required before joining.
  • You are taking another drug that stops blood clots from breaking down, or you have a confirmed active COVID-19 infection.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TX