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RecruitingInterventionalPhase 3

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

NCT ID: NCT05053867Sponsor: M.D. Anderson Cancer CenterLast updated: 2026-01-14

Summary

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.

Detailed description

Primary Objective: To assess the benefit of using nebulized tranexamic acid versus the standard of care on 30 day mortality. Secondary Objectives: To assess the following outcomes when using nebulized tranexamic acid versus the standard of care: 1. 100 day, ICU and hospital mortality rate 2. Ventilator days at day 30 3. ICU and Hospital Length of Stay 4. PaO2:FIO2 ratio (or SpO2:FIO2 ratio) changes over the first 14 days 5. Time to resolution of pulmonary hemorrhage 6. Rate of recurrence of pulmonary hemorrhage 7. Rate of invasive procedures required to control pulmonary hemorrhage

Arms & interventions

  • Drugtranexamic acid

    Inhaled

  • OtherUsual Care

    Standard of Care

Outcome measures

Primary

  • 28 day all-cause mortality rate

    Number of patients who are alive at 28 days following randomization. The difference between 28-day mortality rates between treatment arms will be computed along with a 95% confidence interval (CI) using the approximate standard error reported in Fleiss (1981). Logistic regression will be used to estimate the association between 28-day mortality and study covariates of interest.

    Time frame: up to 28 days

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

M D Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Nisha Rathi, MD · Contact
Nisha Rathi, MD · Principal Investigator
A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients | Cancerify