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RecruitingNCT05053867Updated Jul 16, 2026

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

A Phase 3 interventional study of tranexamic acid and Usual Care in Pulmonary Hemorrhage and Cancer, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by M.D. Anderson Cancer Center · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2022; still recruiting 3 years 11 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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
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Conditions studied

  • Pulmonary Hemorrhage
  • Cancer

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age > 18 years old
  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

2.3.2 Exclusion Criteria

Patients excluded from participation in the study if any of the following criteria are met:

  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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study 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

    Drug: tranexamic acid

  • Other
    Group B: Usual Care

    usual care

    Other: Usual Care

Interventions

  • Drugtranexamic acid

    Inhaled

  • OtherUsual Care

    Standard of Care

06

What researchers measure

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 days

07

Study locations

1 of 1 sites recruiting
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
    • Nisha Rathi, MD · Contact · nrathi@mdanderson.org · 713-745-5787
    • Nisha Rathi, MD · Principal investigator
    Recruiting
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05053867
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Sep 23, 2021
Start date
Oct 14, 2022
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Jul 16, 2026

Study contacts

Nisha Rathi, MD
Contact
nrathi@mdanderson.org
713-745-5787
Nisha Rathi, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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