NCT05053867RecruitingPhase 3
A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 2 Sept 2021
- Start date
- 14 Oct 2022
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- NCT number
- NCT05053867
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 60
- From 14 Oct 2022 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
- 2.3.2 Exclusion Criteria
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.