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

StatusRecruiting
PhasePhase 3
Started2022-10-14
View on ClinicalTrials.gov ↗

Amendment history

2026-07-15
2 amendments v16-v17
2 re-verifications since 2026-01-12, no change to tracked fields
2025-07-07
Study Status, Oversight, IPDSharing v15
Primary completion date2025-07-31→2027-07-31
Completion date2025-07-31→2027-07-31
2025-01-24
Study Status, Oversight, IPDSharing v14
Re-verified, no change to tracked fields
2024-07-19
Study Status v13
Primary completion date2024-07-31→2025-07-31
Completion date2024-07-31→2025-07-31
2024-06-06
2 amendments v11-v12
2 re-verifications since 2023-11-30, no change to tracked fields
Show 10 earlier versions
2023-11-14
Study Status, Study Description v10
Study description-75 characters
Primary Objective: To assess the benefit of using nebulized tranexamic acid versus the standard of care on 2830 day mortality. Secondary Objectives: To assess the followin [...] sing nebulized tranexamic acid versus the standard of care: 90100 day, ICU and hospital mortality rate Ventilator days at day 2830 ICU and Hospital Length of Stay PaO2:FIO2 ratio (or SpO2:FI [...] invasive procedures required to control pulmonary hemorrhage Changes in Lung Injury Score over the first 14 days following randomization
2023-09-11
2 amendments v8-v9
2 re-verifications since 2023-08-24, no change to tracked fields
2023-06-22
Study Status v7
Primary completion date2023-07-30→2024-07-31
Completion date2023-07-30→2024-07-31
2022-10-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-07-30→confirmed 2022-10-14
Study sitesdetails revised at 1 of 1 site
2022-06-10
Study Identification, Study Status v5
Primary completion date2023-03-31→2023-07-30
Completion date2023-03-31→2023-07-30
Start date2022-04-01→2022-07-30
2022-01-28
Study Status v4
Primary completion date2023-01-01→2023-03-31
Completion date2023-01-01→2023-03-31
Start date2022-02-28→2022-04-01
2022-01-28
Study Status v3
Start date2022-01-01→2022-02-28
2021-11-03
Study Status, Outcome Measures v2
Primary endpoints1 entry, revised
To assess the benefit of using nebulized tranexamic acid versus the standard of care on 28 day all-cause mortality. rate
2021-10-25
Study Status, Study Design, Outcome Measures v1
PhaseEarly Phase 1→Phase 3
Primary endpoints1 entry, revised
ExamineTo ifassess inhaledthe benefit of using nebulized tranexamic acid canversus improvethe standard of care on 28 day mortality in patients with cancer-related pulmonary hemorrhage and respiratory failure as compared to usual care.
2021-09-20
Original filing
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.
Trial Details
NCT Number NCT05053867
Lead Sponsor M.D. Anderson Cancer Center
Conditions Pulmonary Hemorrhage, Cancer
Enrollment 60 participants
Start Date 2022-10-14
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-16