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
- Diseases
- Cystic fibrosis
- 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
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Completed |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Completed |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Completed |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Completed |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Completed |
| Hôpital NOVO Coordinator of this site? Confirm its status | Pontoise | France | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.