ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.
Assistance Publique - Hôpitaux de Paris
315 participants
Mar 27, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria12
- 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
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Interventions
Jet nebulization (a device connected by tubing to compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol, which is then inhaled by the patient). The nebulization lasts 10 minutes. Posology: 500 mg x 3/day (= 500 mg / 8 hours) Treatments duration: 3 days
Jet nebulization (a device connected by tubing to compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol, which is then inhaled by the patient). The nebulization lasts 10 minutes. Posology: 1 mg x 3/day (= 1 mg / 8 hours) Treatments duration: 3 days
Jet nebulization (a device connected by tubing to compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol, which is then inhaled by the patient). The nebulization lasts 10 minutes. Posology: 5ml x 3/day (= 5 ml / 8 hours) Treatments duration: 3 days.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04961528