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.
In over 90% of cases, hemoptysis is due to a bronchial or non-bronchial systemic arterial mechanism. Embolization of Bronchial Arteries (EBA) is the main specific treatment but is not easily available. Medical treatment for hemoptysis is not evidence-based. For this study, the investigators will dispense trial drugs using inhalation route which has not been evaluated in mild to severe hemoptysis in previous trials. In addition, as opposed to previous trials, the investigators will assess the safety of trials drugs during hospital stay. Acid tranexamic (TXA), an antifibrinolytic drug, reduces bleeding in uterine and traumatic haemorrhage by blocking the action of plasmin on fibrin. Intravenous terlipressin (TER), a vasoconstrictor, contributes to control digestive haemorrhage but presents many contraindication when administrated by intravenous route. The investigator hypothetize that inhaled antifibrinolytic (TXA) or vasoconstrictor (TER) will be associated with an increase in the rapid control of hemoptysis without side-effects. Patients will be randomized into 3 groups: * Active treatment 1: Tranexamic Acid 500 mg three times a day (every 8 hours) for 5 days. * Active treatment 2: Terlipressin 1 mg three times a day (every 8 hours) for 5 days. * Placebo: normal saline nebulization three times a day (every 8 hours) for 5 days. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
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.
AP-HP, Hôpital Européen Georges Pompidou
Paris, France
RECRUITINGNumber of patients with complete or partial resolution of hemoptysis without the use of any interventional procedure.
Efficacy of inhaled tranexamic acid and inhaled terlipressin versus placebo (normal saline) in immediate control of mild to severe hemoptysis within the first 3 days of hospitalization. A complete resolution of hemoptysis is defined by absence of recurrence within 3 days; partial resolution is defined as hemoptysis recurrence \< 50 ml within the first 3 days
Time frame: 3 days
Rate of complete resolution of hemoptysis within 3 days, as previously defined
Complete resolution of hemoptysis, as previously defined
Time frame: 3 days
Rate of partial resolution of hemoptysis defined as recurrence < 50 ml
Partial resolution of hemoptysis, as previously defined
Time frame: 3 days
Rate of patients with total volume of hemoptysis < 200 ml
Total volume of hemoptysis \< 200 ml
Time frame: 3 days
Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization)
Need of invasive procedure such as bronchial arterial endovascular embolization
Time frame: 3 days
Time between hospital admission and bronchial arterial endovascular embolization
Time between hospital admission and endovascular treatment
Time frame: 3 days
Rate of patients who need a mechanical ventilation
Need of invasive procedure such as mechanical ventilation,
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Enrollment
315
Time frame: 3 days
Rate of specific adverse events
Specific Adverse Events (AE) : acute myocardial ischemia, symptomatic venous thromboembolism, hyponatremia (\<130 mmol/L), bronchospasm (defined by the need of short-acting bronchodilatator).
Time frame: 3 days
Rate of in-hospital mortality
Time frame: 30 days
Rate of patients with hemoptysis recurrence
Time frame: 30 days
Death rate
Time frame: 30 days