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NCT05053867 | RECRUITING | Pulmonary Hemorrhage

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

M.D. Anderson Cancer Center

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.

Condition or disease

Pulmonary Hemorrhage

Cancer

Intervention/treatment

tranexamic acid

Usual Care

Phase

PHASE3

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
Actual Study Start Date : 2022-10-14
Estimated Primary Completion Date : 2025-07-31
Estimated Study Completion Date : 2025-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
  • 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
A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients

Location Details

NCT05053867

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How to Participate

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Locations

RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030