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Inhaled drug could stop deadly lung bleeding in cancer patients

NCT ID NCT05053867

Disease control Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study tests whether inhaling a drug called tranexamic acid can help stop lung bleeding in cancer patients who are on breathing machines. The trial includes 60 adults with blood cancers and severe lung bleeding. Half will get the inhaled drug plus usual care, and half will get usual care alone. The main goal is to see if more patients are alive 28 days later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tranexamic acid (inhaled)
What this could lead to
If it works, this could provide a new way to control severe lung bleeding in cancer patients, potentially saving lives in the intensive care unit.
What could go wrong
This is a small early-phase trial with only 60 participants, so results may not apply broadly. The drug may not improve survival and could have side effects like blood clots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cancer hematopoietic and lymphoid system neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer Pulmonary hemorrhage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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