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ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
315
Start Date
2022-03-27
Completion Date
2026-01-31
Last Updated
2024-05-03
Healthy Volunteers
No
Conditions
Interventions
Tranexamic Acid 500 MG
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
Terlipressin
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
Placebo
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)
AP-HP, Hôpital Européen Georges Pompidou
Paris, France