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

NCT05053867 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2019-0991NCI-2021-09676
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hemorrhage; Cancer

Outcome Measures

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.

  up to 28 days

Study Arms (2)

Group A: Inhaled tranexamic acid

EXPERIMENTAL

will receive 500 mg/5ml nebulized tranexamic acid every 8 hours for at least 3 days, and up to 5 days

Drug: tranexamic acid

Group B: Usual Care

OTHER

usual care

Other: Usual Care

Interventions

Usual Care OTHER

Standard of Care

Group B: Usual Care

tranexamic acid DRUG

Inhaled

Group A: Inhaled tranexamic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Have a diagnosed hematological malignancy
• Are actively receiving mechanical ventilation
• Have evidence of pulmonary hemorrhage as defined by either
• Persistently bloody secretions upon endotracheal tube suctioning, or
• Evidence of diffuse alveolar hemorrhage by bronchoscopic examination
• Signed informed consent by patient or if the subject lacks decision-making capacity, the subject's legally authorized representative

You may not qualify if:

• Patients excluded from participation in the study if any of the following criteria are met:
• 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
• Known hypersensitivity to tranexamic acid
• Treatment with inhaled tranexamic acid prior to screening
• Acquired defective color vision
• Subarachnoid hemorrhage
• Deep Venous or arterial thrombus diagnosed within the previous 3 months
• Seizure disorder on active anti-epileptic therapies
• Hypersensitivity to tranexamic acid or any of the ingredients
• Pregnant women will not be eligible and have a negative pregnancy test prior to entering study
• Patient receiving concurrent anti-fibrinolytic therapy
• Confirmed active COVID-19 infection

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Neoplasms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Nisha Rathi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nisha Rathi, MD

CONTACT

713-745-5787; nrathi@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 23, 2021
• Study Start: October 14, 2022
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)