Clinical trial · Interventional
A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
NCT05053867CI-TRIAL-00118209recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pulmonary Hemorrhage | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tranexamic acid | Drug | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A: Inhaled tranexamic acid
- description
- will receive 500 mg/5ml nebulized tranexamic acid every 8 hours for at least 3 days, and up to 5 days
- interventionNames
- Drug: tranexamic acid
- type
- OTHER
- label
- Group B: Usual Care
- description
- usual care
- interventionNames
- Other: Usual Care
Primary outcomes (1)
- measure
- 28 day all-cause mortality rate
- timeFrame
- up to 28 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.