ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.

What Was Tested

This registered phase 3 trial tested Terlipressin.

This randomized double-blind multicenter triple arm trial compares the administration of TXA to TER to placebo in patients with mild to severe hemoptysis.

It had three arms (groups): Terlipressin (experimental), Tranexamic Acid (experimental) and Normal Saline Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Embolization of Bronchial Arteries (EBA) is the main specific treatment but is not easily available.

Medical treatment for hemoptysis is not evidence-based.

For this study, the investigators will dispense trial drugs using inhalation route which has not been evaluated in mild to severe hemoptysis in previous trials.

In addition, as opposed to previous trials, the investigators will assess the safety of trials drugs during hospital stay.

Who Took Part

Enrollment: 315 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients over 18 years, under 90 years. Mild to severe hemoptysis that has been going on for less than 7 days. Admission in emergency department or ICU for less than 12 hours. Social security affiliation. Signed informed consent.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: need for mechanical ventilation; cystic fibrosis; pregnancy or breast feeding.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Terlipressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Terlipressin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2022-03-27 with completion listed for 2025-12-28.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of patients with complete or partial resolution of hemoptysis without the use of any interventional procedure (time frame: 3 days).

It also tracked 10 secondary outcomes, for example Rate of complete resolution of hemoptysis within 3 days, as previously defined, Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization), Time between hospital admission and bronchial arterial endovascular embolization, Rate of patients who need a mechanical ventilation, Rate of specific adverse events and Rate of in-hospital mortality.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Terlipressin in 315 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Terlipressin compound page, all human trials.