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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05053867
• Other study ID #: 2019-0991
• Secondary ID: NCI-2021-09676
• Status: Recruiting
• Phase: Phase 3
• Start date: October 14, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: Nisha Rathi, MD
• Phone: 713-745-5787
• Email: nrathi[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Hemorrhage
• Pulmonary Hemorrhage

Intervention

Drug:
• tranexamic acid
Inhaled

Other:
• Usual Care
Standard of Care

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center