Hemoptysis, whatever the cause, with the exception of cystic fibrosis
Conditions
Interventions
Trade Name: GLYPRESSINE 1 mg/5 mL, poudre et solvant pour solution injectable (I.V.)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TERLIPRESSIN
CAS Number: 14636-12-5
Other descrip
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess efficacy of inhaled TXA and inhaled TER versus placebo (normal saline) in immediate control of mild to severe hemoptysis within the first 5 days of hospitalization.;Secondary Objective: The secondary objectives are to compare active treatments (TXA and TER) to placebo (pairwise comparison) on the following parameters: - Complete resolution of hemoptysis - Partial resolution of hemoptysis - 30-day hemoptysis recurrence rate - Total volume of hemoptysis - Need and time of invasive procedure such as bronchial arterial endovascular embolization, mechanical ventilation, - Safety - Hospital mortality - 30-day mortality Using a hierarchical analysis, the comparison between TXA and TER will be tested once superiority on efficacy of both inhaled TXA and TER vs placebo is demonstrated. The above secondary objectives will then be assessed for the comparison of TXA versus TER. The identification of risk factors for hemoptysis recurrences will also be assessed.;Primary end point(s): The primary end-point is defined as the proportion of patients with complete or partial resolution of hemoptysis without the use of any interventional procedure. A complete resolution of hemoptysis is defined by absence of recurrence within 5 days; partial resolution is defined as hemoptysis recurrence < 50 mL within the first 5 days.;Timepoint(s) of evaluation of this end point: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For each treatment group, the following endpoints will be assessed: - Rate of complete resolution of hemoptysis within 5 days, as previously defined - Rate of partial resolution of hemoptysis defined as recurrence < 50 mL within 5 days, as previously defined - Proportion of patients with total volume of hemoptysis < 200 mL within 5 days - Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization) within 5 days - Rate of patients who need a mechanical ventilation within 5 days - Time between hospital admission and endovascular treatment - In-hospital mortality - 30-day rate of patients with hemoptysis recurrence - 30-day mortality - Rate of specific adverse events : acute myocardial ischemia, symptomatic venous thromboembolism, hyponatremia (<130 mmol/L), bronchospasm (defined by the need of short-acting bronchodilatator). Anticipated candidate’s variables for the assessment of the hemoptysis recurrence riskinclude the followings: age, sex, baseline expectorated blood volume, cause of hemoptysis, previous hemoptysis, coagulation disorders, need in mechanical ventilation, treatment group.;Timepoint(s) of evaluation of this end point: 30 days | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Outcome results
None listed