A Randomized Controlled Trial of Inhaled Tranexamic Acid... | NCT05053867

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

NCT05053867

Sponsor

M.D. Anderson Cancer Center

Status

Recruiting

Last Update Posted

Jan 14, 2026Actual

Enrollment

60Estimated

Phase

Phase 3

Conditions

Pulmonary Hemorrhage
Cancer

Interventions

tranexamic acid
Usual Care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2021-09676	Other Identifier	NCI-CTRP Clinical Trials Gov Registry

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 14, 2022Actual

Primary Completion Date

Jul 31, 2027Estimated

Completion Date

Jul 31, 2027Estimated

First Submitted Date

Sep 2, 2021

First Submission Date that Met QC Criteria

Sep 20, 2021

First Posted Date

Sep 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2026

Last Update Posted Date

Jan 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

100 day, ICU and hospital mortality rate
Ventilator days at day 30
ICU and Hospital Length of Stay
PaO2:FIO2 ratio (or SpO2:FIO2 ratio) changes over the first 14 days
Time to resolution of pulmonary hemorrhage
Rate of recurrence of pulmonary hemorrhage
Rate of invasive procedures required to control pulmonary hemorrhage

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A: Inhaled tranexamic acid	Experimental	will receive 500 mg/5ml nebulized tranexamic acid every 8 hours for at least 3 days, and up to 5 days	Drug: tranexamic acid
Group B: Usual Care	Other	usual care	Other: Usual Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tranexamic acid	Drug	Inhaled	Group A: Inhaled tranexamic acid
Usual Care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years old
Have a diagnosed hematological malignancy
Are actively receiving mechanical ventilation
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
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:

Presence of a Do Not Resuscitate (DNR), no escalation of care or comfort care order at the time of screening
Expected survival < 48 hours
Evidence of nasal or oral spillage likely to be the cause of bloody secretions
Patients requiring 100% FIO2
Known hypersensitivity to tranexamic acid
Treatment with inhaled tranexamic acid prior to screening
Acquired defective color vision
Subarachnoid hemorrhage
Deep Venous or arterial thrombus diagnosed within the previous 3 months
Seizure disorder on active anti-epileptic therapies
Hypersensitivity to tranexamic acid or any of the ingredients
Pregnant women will not be eligible and have a negative pregnancy test prior to entering study
Patient receiving concurrent anti-fibrinolytic therapy
Confirmed active COVID-19 infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals