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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05053867
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

Study Description

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	Intervention/Treatment	Phase
Pulmonary Hemorrhage; Cancer	Drug: tranexamic acid; Other: Usual Care	Phase 3

Detailed Description

Primary Objective: To assess the benefit of using nebulized tranexamic acid versus the standard of care on 28 day mortality.

Secondary Objectives: To assess the following outcomes when using nebulized tranexamic acid versus the standard of care:

1. 90 day, ICU and hospital mortality rate

2. Ventilator days at day 28

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

8. Changes in Lung Injury Score over the first 14 days following randomization

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
• Anticipated Study Start Date: Jul 30, 2022
• Anticipated Primary Completion Date: Jul 30, 2023
• Anticipated Study Completion Date: Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
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; Inhaled
Other: Group B: Usual Care usual care	Other: Usual Care; Standard of Care

Outcome Measures

Primary Outcome Measures

1. 28 day all-cause mortality rate [up to 28 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

5. Persistently bloody secretions upon endotracheal tube suctioning, or

6. Evidence of diffuse alveolar hemorrhage by bronchoscopic examination

7. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Nisha Rathi, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05053867
• Other Study ID Numbers: 2019-0991; NCI-2021-09676
• First Posted: Sep 23, 2021
• Last Update Posted: Jun 13, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemorrhage; Tranexamic Acid

Study Results

No Results Posted as of Jun 13, 2022