A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tranexamic acid, Usual Care.
- Who it may be relevant to
- Registry conditions: Pulmonary Hemorrhage, Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug tranexamic acid
Inhaled - Other Usual Care
Standard of Care
Primary outcome measures
- 28 day all-cause mortality rate [Time frame: up to 28 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05053867 · 2019-0991 · NCI-2021-09676