A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years old
Have a diagnosed hematological malignancy
Are actively receiving mechanical ventilation
Have evidence of pulmonary hemorrhage as defined by either
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
tranexamic acid
DrugInhaled
Usual Care
Other interventionStandard of Care
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group A: Inhaled tranexamic acidExperimental treatment 1 intervention
Group B: Group B: Usual CareOther 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSponsors and contacts
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Source ClinicalTrials.gov