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

Primary Purpose

Pulmonary Hemorrhage, Cancer

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

tranexamic acid

Usual Care

About this trial

This is an interventional treatment trial for Pulmonary Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A: Inhaled tranexamic acid

Group B: Usual Care

Arm Description

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

usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05053867

First Posted

September 2, 2021

Last Updated

September 11, 2023

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05053867

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 14, 2022 (Actual)

Primary Completion Date

July 31, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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: 90 day, ICU and hospital mortality rate Ventilator days at day 28 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 Changes in Lung Injury Score over the first 14 days following randomization

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hemorrhage, Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A: Inhaled tranexamic acid

Arm Type

Experimental

Arm Description

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

Arm Title

Group B: Usual Care

Arm Type

Other

Arm Description

usual care

Intervention Type

Drug

Intervention Name(s)

tranexamic acid

Intervention Description

Inhaled

Intervention Type

Other

Intervention Name(s)

Usual Care

Intervention Description

Standard of Care

Primary Outcome Measure Information:

Title

28 day all-cause mortality rate

Description

Time Frame

up to 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 Persistently bloody secretions upon endotracheal tube suctioning, or 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nisha Rathi, MD

Phone

713-745-5787

nrathi@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nisha Rathi, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nisha Rathi, MD

Phone

713-745-5787

nrathi@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Nisha Rathi, MD

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

M D Anderson Cancer Center

Learn more about this trial

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

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