ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.

Hemoptysis Clinical Trial

— ACTIVE  

Official title:

ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961528
• Other study ID #: APHP200043
• Secondary ID: 2020-005931-58PH
• Status: Recruiting
• Phase: Phase 3
• Start date: March 27, 2022
• Est. completion date: January 31, 2026

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Karine Goude-Ory
• Phone: 01 44 84 17 22
• Email: karine.goude[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients over 18 years, under 90 years
• Mild to severe hemoptysis that has been going on for less than 7 days
• 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)
• 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

Related Conditions & MeSH terms

• Emergencies
• Hemoptysis

Intervention

Drug:
• 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

Country	Name	City	State
France	AP-HP, Hôpital Européen Georges Pompidou	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number 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	3 days
Secondary	Rate of complete resolution of hemoptysis within 3 days, as previously defined	Complete resolution of hemoptysis, as previously defined	3 days
Secondary	Rate of partial resolution of hemoptysis defined as recurrence < 50 ml	Partial resolution of hemoptysis, as previously defined	3 days
Secondary	Rate of patients with total volume of hemoptysis < 200 ml	Total volume of hemoptysis < 200 ml	3 days
Secondary	Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization)	Need of invasive procedure such as bronchial arterial endovascular embolization	3 days
Secondary	Time between hospital admission and bronchial arterial endovascular embolization	Time between hospital admission and endovascular treatment	3 days
Secondary	Rate of patients who need a mechanical ventilation	Need of invasive procedure such as mechanical ventilation,	3 days
Secondary	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).	3 days
Secondary	Rate of in-hospital mortality		30 days
Secondary	Rate of patients with hemoptysis recurrence		30 days
Secondary	Death rate		30 days