ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial. (ACTIVE)
Hemoptysis
About this trial
This is an interventional treatment trial for Hemoptysis focused on measuring terlipressin, tranexamic acid
Eligibility Criteria
Inclusion Criteria:
- Patients over 18 years, under 90 years
- Mild to severe hemoptysis that has been going on for less than 72 hours
- 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)
- Absolute need for anticoagulant treatment at curative dosage (recent venous thrombo-embolism in the 6 past months)
- 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
Sites / Locations
- AP-HP, Hôpital Européen Georges PompidouRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Terlipressin
Tranexamic Acid
Normal Saline Placebo
Dosage: 1 mg /5 ml Pharmaceutical form: solution for infusion Posology: 1 mg /8 hours Treatment duration: 5 days Method and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers
Dosage : 500 mg /5 ml Pharmaceutical form: solution for infusion Posology (and adjustments based on toxicity) : 500 mg/ 8 hours Treatment duration: 5 days Method and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers.
Dose : normal saline solution (NaCl 0.9%) Pharmaceutical form : solution for infusion Posology : 5ml / 8 hours Treatment duration: 5 days Method and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers.