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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two medications, inhaled Tranexamic Acid (TXA) and Terlipressin (TER), to see if they can quickly stop coughing up blood, a condition known as hemoptysis. The goal is to find out if these treatments are safe and effective compared to a placebo (a treatment with no active ingredients). The study is open to adults aged 18 to 89 who have been experiencing mild to severe hemoptysis for less than a week and have been admitted to the emergency department or ICU for less than 12 hours. Participants must also be able to give their consent and meet specific health criteria.

If you choose to participate, you will be randomly assigned to receive either TXA, TER, or a placebo, and neither you nor the researchers will know which treatment you are getting. This helps ensure that the results are fair and unbiased. The trial is currently recruiting participants, and they will closely monitor your health throughout the study to assess how well the treatments work and if there are any side effects. It's important to note that certain conditions, such as pregnancy, severe kidney issues, or recent heart problems, may exclude you from participating.

Gender

ALL

Eligibility criteria

• Inclusion 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
• 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)
• • 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