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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    315
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 25 May 2022
tranexamic acid
terlipressin

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.

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.

Details
Condition Hemoptysis
Treatment Placebo, Tranexamic Acid 500 MG, Terlipressin
Clinical Study IdentifierNCT04961528
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients over 18 years, under 90 years
Mild to severe hemoptysis that has been going on for less than 72 hours
Total expectorate blood ranging from 50 ml to 200 ml
Admission in emergency department or ICU for less than 12 hours
Social security affiliation
Signed informed consent
For child-bearing aged women, efficient contraception includes oral oestrogenprogestin, oral progestin, progestin implants and all types of intrauterine devices

Exclusion Criteria

Need for mechanical ventilation
Cystic fibrosis
Pregnancy or breast feeding
Contraindication for contrast agents injection (renal failure with creatinin clearance < 30mL/min, know allergy to contrast agents injection)
Absolute need for anticoagulant treatment at curative dosage (recent venous thrombo-embolism in the 6 past months)
Known hypersensitivity to TXA or TER or one of its excipients
Know previous cardiac arrhythmia (atrial fibrillation, atrial flutter..)
Contraindication to TXA (including renal failure with creatinin clearance < 30mL/min) or TER therapy
acute myocardial infarction in the 6 past months
intrathecal injection in the 3 past months
seizure in the past 3 months
Participation in another interventional study or being in the exclusion period at the
end of a previous study
Patient under tutorship or / guardianship, and incapable to give informed consent
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