Fact CheckerSign in

NCT04961528CompletedPhase 3

AcTIVE - ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis: a randomized Trial

Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Apr 2025

Brief summary (registry, in English)

The main objective is to assess efficacy of inhaled TXA and inhaled TER versus placebo (normal saline) in immediate control of mild to severe hemoptysis within the first 3 days of hospitalization. Using a hierarchical analysis, the comparison between TXA and TER will be tested once superiority on efficacy of both inhaled TXA and TER groups vs placebo group is demonstrated. If the first step is unsuccessful, TXA versus TER comparison will be regarded as exploratory.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
315 (actual)
First submitted
3 Sept 2024
Start date
28 Mar 2022
Lead sponsor
Assistance Publique Hopitaux De Paris
NCT number
NCT04961528
EU CT number
2024-515010-40-00
EudraCT number
2020-005931-58

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 315
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Know previous cardiac arrhythmia (atrial fibrillation, atrial flutter..)
  • Participation in another interventional study or being in the exclusion period at the end of a previous study

Other illness

  • Known hypersensitivity to TXA or TER or one of its excipients

Lab values

  • Contraindication for contrast agents injection (renal failure with creatinin clearance < 30ml/min, know allergy to contrast agents injection)
  • 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

Other

  • Need for mechanical ventilation
  • Cystic fibrosis
  • Pregnancy or breast feeding
  • Patient under tutorship or / guardianship, and incapable to give informed consent

Who the study is looking for

  • Patients over 18 years, under 90 years
  • Mild to severe hemoptysis that has been going on for less than 7 days
  • 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 oestrogen-progestin, oral progestin, progestin implants and all types of intrauterine devices

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire Amiens Picardie
Coordinator of this site? Confirm its status
Amiens Cedex 1FranceCompleted
Centre Hospitalier Universitaire De Caen Normandie
Coordinator of this site? Confirm its status
Caen Cedex 9FranceCompleted
University Hospital Of Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceCompleted
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Le Kremlin-BicetreFranceCompleted
Centre Hospitalier Universitaire de Lille
Coordinator of this site? Confirm its status
LilleFranceCompleted
Assistance Publique Hopitaux de Paris
Coordinator of this site? Confirm its status
ParisFranceCompleted
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Paris Cedex 13FranceCompleted
Centre Hospitalier Universitaire de Poitiers
Coordinator of this site? Confirm its status
PoitiersFranceCompleted
Hôpital NOVO
Coordinator of this site? Confirm its status
PontoiseFranceCompleted
Centre Hospitalier Universitaire de Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceCompleted

This page is information, not medical advice. Discuss any trial with your doctor.