A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
NCT ID: NCT05053867
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2022-10-14
2027-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group A: Inhaled tranexamic acid
will receive 500 mg/5ml nebulized tranexamic acid every 8 hours for at least 3 days, and up to 5 days
tranexamic acid
Inhaled
Group B: Usual Care
usual care
Usual Care
Standard of Care
Interventions
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tranexamic acid
Inhaled
Usual Care
Standard of Care
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nisha Rathi, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2021-09676
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0991
Identifier Type: -
Identifier Source: org_study_id
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