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Breathing in medicine may stop lung bleeding faster than IV

NCT ID NCT07641946

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 Results may not be published yet.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

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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

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First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests two ways of giving tranexamic acid, a drug that helps blood clot, to adults who are coughing up blood. One group breathes the medicine in through a mask (nebulizer), while the other gets it through an IV. The goal is to see which method stops the bleeding within 24 hours more effectively. 170 participants will be randomly assigned to either group, and researchers will also track how quickly bleeding stops, hospital stay length, and side effects.

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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 170 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 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: * Age ≥18 years. * Presenting with active hemoptysis 24-48 hours prior to enrollment, or ongoing bleeding at presentation. * Patients presented with mild to moderate hemoptysis, defined as \<100 mL/day, or with clinically stable non-massive hemoptysis without evidence of respiratory or hemodynamic compromise. * Hemodynamically stable at presentation defined as systolic blood pressure ≥90 mmHg without vasopressor support, heart rate ≤120 beats/min, and absence of clinical signs of shock or ongoing hemodynamic deterioration. * Patients able to maintain a patent airway, tolerate nebulized therapy, and have no immediate contraindications (e.g., severe bronchospasm, impaired consciousness with aspiration risk, or need for urgent intubation), ensuring safe and effective drug delivery. * Written informed consent obtained from the patient. Exclusion Criteria: * Massive or life-threatening hemoptysis defined as expectoration of \>100 mL of blood within 24 hours, or any volume associated with impaired gas exchange, airway obstruction, or hemodynamic instability requiring urgent intervention (e.g., bronchoscopy, bronchial artery embolization, endotracheal intubation, or surgery). * Hemodynamic instability which defined as SBP \<90 mmHg or MAP \<65 mmHg, need for vasopressor support, or clinical evidence of end-organ hypoperfusion or shock. * Respiratory failure requiring immediate invasive mechanical ventilation. * Patients known with hypersensitivity to tranexamic acid. * Patients receiving ongoing anticoagulant therapy that can interfere with the antifibrinolytic effect of tranexamic acid. * Patients with known bleeding disorders, severe coagulopathy, or thrombocytopenia (platelet count \<50,000/mm³). * Patients with severe renal impairment (e.g., estimated glomerular filtration rate \<30 mL/min/1.73 m² or requiring dialysis). * Patients with active thromboembolic disease or a recent history (within the past 3-6 months) of deep vein thrombosis, pulmonary embolism, ischemic stroke, or myocardial infarction. * Pregnancy or lactation.

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Conditions

The condition(s) this trial relates to.

Hemoptysis

As listed by the trial registrant

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

How to take part

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