ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to

Status Recruiting

Clinical Trial Summary

The study aims is to verify the hypothetize that inhaled Tranexamic Acid (TXA) or Terlipressin (TER) will be associated with an increase in the rapid control of hemoptysis without side-effects. This randomized double-blind multicenter triple arm trial compares the administration of TXA to TER to placebo in patients with mild to severe hemoptysis.

Clinical Trial Description

In over 90% of cases, hemoptysis is due to a bronchial or non-bronchial systemic arterial mechanism. 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. Acid tranexamic (TXA), an antifibrinolytic drug, reduces bleeding in uterine and traumatic haemorrhage by blocking the action of plasmin on fibrin. Intravenous terlipressin (TER), a vasoconstrictor, contributes to control digestive haemorrhage but presents many contraindication when administrated by intravenous route. The investigator hypothetize that inhaled antifibrinolytic (TXA) or vasoconstrictor (TER) will be associated with an increase in the rapid control of hemoptysis without side-effects. Patients will be randomized into 3 groups: - Active treatment 1: Tranexamic Acid 500 mg three times a day (every 8 hours) for 5 days. - Active treatment 2: Terlipressin 1 mg three times a day (every 8 hours) for 5 days. - Placebo: normal saline nebulization three times a day (every 8 hours) for 5 days. Using a hierarchical analysis, the comparison between TXA and TER will be tested once superiority on efficacy of both inhaled TXA and TER vs placebo is demonstrated. The above secondary objectives will then be assessed for the comparison of TXA versus TER. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04961528
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact	Karine Goude-Ory
Phone	01 44 84 17 22
Email	karine.goude@aphp.fr
Status	Recruiting
Phase	Phase 3
Start date	March 27, 2022
Completion date	April 30, 2024

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms