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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

28 day all-cause mortality rate

Side effects data

From 2011 Phase 4 trial • 20 Patients • NCT01190150

Blister

100%

80%

60%

40%

20%

Study treatment Arm

0.65 g Tranexamic Acid

1.3 g Tranexamic Acid

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

~1780

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,286 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is tranexamic acid an FDA-regulated medication?

"Tranexamic acid has undergone multiple rounds of testing and has been proven effective, so it received a score of 3."

Answered by AI

What are some popular indications for tranexamic acid?

"Tranexamic acid is the most common medical intervention for hyperfibrinolysis. That said, this medication can also help patients with conditions such as hemophilia, bleeding, and who are undergoing tooth extractions."

Answered by AI

What is the precedent for using tranexamic acid in clinical trials?

"As of this date, there are 69 ongoing clinical trials researching tranexamic acid. Out of those 69, 29 are in Phase 3. The majority of these studies are based in Kansas City, but there are 305 total locations running these trials."

Answered by AI

Are patients being recruited for this experiment currently?

"This study is still recruiting patients, as of the last update on clinicaltrials.gov which was on 10/17/2022. The original posting date for the trial was 10/14/2022."

Answered by AI

How many patients are being admitted into this research project?

"The latest information available on clinicaltrials.gov does show that this trial is still recruiting patients. According to the listing, the trial was first posted on October 14th, 2022 and is currently looking for 60 participants from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05053867.