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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05053867
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cancer
  • Pulmonary Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tranexamic acid — DRUG
    Inhaled
  • Usual Care — OTHER
    Standard of Care

Study Details

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.

Key Dates

Start date
Oct 14, 2022
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Other: Group B: Usual Care
    usual care

Primary Outcome Measure

28 day all-cause mortality rate [ Time Frame: up to 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Nisha Rathi, MD
[email protected]
713-745-5787
Nisha Rathi, MD (PRINCIPAL_INVESTIGATOR)

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M D Anderson Cancer Center· Houston, TX

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