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Anti-fibrinolytic agent

Inhaled Tranexamic Acid for Bleeding in Cancer Patients

Phase 3
Recruiting
Led By Nisha Rathi
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have evidence of pulmonary hemorrhage as defined by either
Have a diagnosed hematological malignancy
Must not have
Seizure disorder on active anti-epileptic therapies
Confirmed active COVID-19 infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study if inhaled tranexamic acid can improve survival in patients with cancer-related pulmonary hemorrhage and respiratory failure, compared to usual care.

Who is the study for?
This trial is for adults over 18 with blood cancers who are on mechanical ventilation due to lung bleeding. They must be expected to live more than 48 hours, not have a severe brain bleed, no DNR orders, and not be pregnant or have COVID-19. People with recent blood clots, known allergies to tranexamic acid, color vision issues, seizures under treatment, or prior use of inhaled tranexamic acid can't join.
What is being tested?
The study tests if breathing in the drug tranexamic acid helps reduce death rates in cancer patients with lung bleeding compared to standard treatments. Patients will either receive the usual care or the added inhalation therapy and their survival outcomes will be compared.
What are the potential side effects?
Tranexamic acid may cause side effects like coughing or wheezing when inhaled; it could also lead to allergic reactions. There's a risk of increased clotting since it works by stopping bleeds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had bleeding in my lungs.
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I have been diagnosed with a blood cancer.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication for epilepsy.
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I am currently infected with COVID-19.
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I am currently on medication to prevent excessive bleeding.
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I have had a bleeding in the space around my brain.
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I need a 100% oxygen environment.
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I have used inhaled tranexamic acid before screening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
28 day all-cause mortality rate

Side effects data

From 2011 Phase 4 trial • 20 Patients • NCT01190150
6%
Blister
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.65 g Tranexamic Acid
1.3 g Tranexamic Acid

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B: Usual CareExperimental Treatment1 Intervention
usual care
Group II: Group A: Inhaled tranexamic acidExperimental Treatment1 Intervention
will receive 500 mg/5ml nebulized tranexamic acid every 8 hours for at least 3 days, and up to 5 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tranexamic acid
2012
Completed Phase 4
~1810

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,267 Total Patients Enrolled
Nisha RathiPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
256 Total Patients Enrolled
Nisha Rathi, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
257 Total Patients Enrolled

Media Library

Tranexamic Acid (Anti-fibrinolytic agent) Clinical Trial Eligibility Overview. Trial Name: NCT05053867 — Phase 3
Pulmonary Hemorrhage Research Study Groups: Group A: Inhaled tranexamic acid, Group B: Usual Care
Pulmonary Hemorrhage Clinical Trial 2023: Tranexamic Acid Highlights & Side Effects. Trial Name: NCT05053867 — Phase 3
Tranexamic Acid (Anti-fibrinolytic agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05053867 — Phase 3
~13 spots leftby Jul 2025
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