ACTIVE : ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis

Phase 1

• Conditions: Hemoptysis, whatever the cause, with the exception of cystic fibrosis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-005931-58-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-04
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 315

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 190

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
- Contraindication to TXA 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified