RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-14

Study Completion:2025-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05053867

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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
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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Nisha Rathi, MD

CONTACT

713-745-5787

nrathi@mdanderson.org

Principal Investigator

Nisha Rathi, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Nisha Rathi, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-14

Study Completion Date2025-07-31

Study Record Updates

Study Start Date2022-10-14

Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

Pulmonary Hemorrhage
Cancer