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AcTIVE - ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis: a randomized Trial
EU CTIS ID: 2024-515010-40-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
- Known hypersensitivity to TXA or TER or one of its excipients
- Know previous cardiac arrhythmia (atrial fibrillation, atrial flutter..)
See the full eligibility criteria
- 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
- 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)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.