Study on Tranexamic Acid and Terlipressin for Emergency Treatment of Mild to Severe Hemoptysis in Patients Without Cystic Fibrosis

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What is this study about?

This clinical trial is focused on studying the treatment of hemoptysis, which is the coughing up of blood from the lungs or airways. The trial will explore the effectiveness of two medications: tranexamic acid and terlipressin. Both medications will be administered through inhalation, which means they are breathed in using a device called a nebulizer. The purpose of the study is to determine how well these treatments can control mild to severe hemoptysis in patients during the first three days of hospitalization.

Participants in the study will receive either tranexamic acid, terlipressin, or a placebo, which is a substance with no active medication. The trial will monitor the patients to see if the hemoptysis resolves completely or partially without needing any additional medical procedures. Complete resolution means the bleeding stops entirely within three days, while partial resolution means the bleeding reduces significantly.

The study will also track other outcomes, such as the total amount of blood coughed up, the need for further treatments, and any side effects that may occur. This information will help researchers understand the potential benefits and risks of using these medications for treating hemoptysis. The trial is expected to continue until early 2026, with the goal of providing valuable insights into the management of this condition.

1 joining the study

Upon joining the study, you will be required to provide a signed informed consent. This confirms your understanding and agreement to participate in the trial.

You must meet certain criteria, such as being between 18 and 90 years old, having mild to severe hemoptysis for less than 7 days, and having been admitted to the emergency department or ICU for less than 12 hours.

2 initial assessment

An initial assessment will be conducted to evaluate your condition. This includes measuring the total expectorated blood volume, which should range from 50 ml to 200 ml.

Your eligibility for the trial will be confirmed based on this assessment.

3 treatment allocation

You will be randomly assigned to receive one of the following treatments: tranexamic acid, terlipressin, or a placebo (normal saline).

All treatments are administered through inhalation.

4 treatment administration

The treatment will be administered to you for the immediate control of hemoptysis within the first 3 days of hospitalization.

The dosage and frequency of administration will be determined by the medical team overseeing the trial.

5 monitoring and evaluation

Your condition will be closely monitored to assess the effectiveness of the treatment. This includes checking for complete or partial resolution of hemoptysis.

Complete resolution is defined as the absence of recurrence within 3 days, while partial resolution is defined as recurrence of less than 50 ml within the first 3 days.

6 follow-up

You will be followed up to evaluate the long-term outcomes, such as the rate of hemoptysis recurrence within 30 days and any adverse events.

The medical team will also monitor for any specific adverse events, such as acute myocardial ischemia or bronchospasm.

Who Can Join the Study?

Patients must be over 18 years and under 90 years old.
Must have mild to severe hemoptysis (coughing up blood) that has been happening for less than 7 days.
The total amount of blood coughed up should be between 50 ml to 200 ml.
Must have been admitted to the emergency department or ICU for less than 12 hours.
Must have social security affiliation.
Must have signed informed consent, which means agreeing to participate after understanding the study.
For women who can have children, they must use effective contraception methods such as oral estrogen-progestin, oral progestin, progestin implants, or any type of intrauterine device (IUD).

Who Cannot Join the Study?

Patients with hemoptysis (coughing up blood) from any cause, except for those with cystic fibrosis.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital NOVO	Pontoise	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	28.03.2022

Trial locations

Investigated drugs:

Tranexamic Acid is a medication used to help control bleeding. In this trial, it is being tested in an inhaled form to see if it can quickly stop bleeding in the lungs, known as hemoptysis, which can range from mild to severe. The goal is to see if it can effectively control the bleeding within the first three days of hospitalization.

Terlipressin is another medication being tested in this trial. It is also used to manage bleeding, but it works differently from Tranexamic Acid. In this study, it is being used in an inhaled form to determine if it can help stop bleeding in the lungs quickly and effectively during the initial days of hospital treatment for hemoptysis.

Hemoptysis – Hemoptysis is the medical term for coughing up blood from the respiratory tract. It can originate from the lungs or bronchial tubes and is often a symptom of an underlying condition. The blood can vary in color from bright red to rust-colored, depending on the source and duration of bleeding. Hemoptysis can range from mild, with small amounts of blood, to severe, with significant blood loss. The progression of hemoptysis depends on its cause, which can include infections, lung diseases, or trauma. It requires medical evaluation to determine the underlying cause and appropriate management.

Trial ID:

2024-515010-40-00

Protocol code:

APHP200043

NCT ID:

NCT04961528

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Tranexamic Acid and Terlipressin for Emergency Treatment of Mild to Severe Hemoptysis in Patients Without Cystic Fibrosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?