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

Study Overview
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Brief Summary
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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
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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: 100 day, ICU and hospital mortality rate Ventilator days at day 30 ICU and Hospital Length of Stay PaO2:FIO2 ratio (or SpO2:FIO2 ratio) changes over the first 14 days Time to resolution of pulmonary hemorrhage Rate of recurrence of pulmonary hemorrhage Rate of invasive procedures required to control pulmonary hemorrhage

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

Conditions
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Pulmonary Hemorrhage, Cancer

Intervention / Treatment
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* Drug: tranexamic acid
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Inhaled tranexamic acid<br>will receive 500 mg/5ml nebulized tranexamic acid every 8 hours for at least 3 days, and up to 5 days | Drug: tranexamic acid<br>* Inhaled<br>|
| Other: Group B: Usual Care<br>usual care | Other: Usual Care<br>* Standard of Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 28 days |