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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 3

Conditions: Cancer; Pulmonary Hemorrhage

Treatments: Other: Usual Care; Drug: tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05053867

NCI-2021-09676 (Other Identifier)

2019-0991

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A: Inhaled tranexamic acid

Experimental group

Description:

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

Treatment:

Drug: tranexamic acid

Group B: Usual Care

Other group

Description:

usual care

Treatment:

Other: Usual Care