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

NCT04961528 | Completed Phase 3 DMC

• 3 other identifiers: APHP2000432020-005931-58PHRC-19-0412
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemoptysis

Keywords

terlipressin; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Rate of complete resolution of hemoptysis within 3 days, as previously defined

  3 days

• Rate of partial resolution of hemoptysis defined as recurrence < 50 ml

  3 days

• Rate of patients with total volume of hemoptysis < 200 ml

  3 days

• Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization)

  3 days

• Time between hospital admission and bronchial arterial endovascular embolization

  3 days

Study Arms (3)

Terlipressin

EXPERIMENTAL

Dosage: 1 mg /5 ml Pharmaceutical form: solution for infusion Posology: 1 mg /8 hours Treatment duration: 3 days Method and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers

Drug: Terlipressin

Tranexamic Acid

EXPERIMENTAL

Dosage : 500 mg /5 ml Pharmaceutical form: solution for infusion Posology (and adjustments based on toxicity) : 500 mg/ 8 hours Treatment duration: 3 days Method and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers.

Drug: Tranexamic Acid 500 MG

Normal Saline Placebo

PLACEBO COMPARATOR

Dose : normal saline solution (NaCl 0.9%) Pharmaceutical form : solution for infusion Posology : 5ml / 8 hours Treatment duration: 3 days Method and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers.

Drug: Placebo

Interventions

Tranexamic Acid 500 MG DRUG

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

Tranexamic Acid

Terlipressin DRUG

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

Terlipressin

Placebo DRUG

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.

Also known as: Normal saline placebo

Normal Saline Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient under tutorship or / guardianship, and incapable to give informed consent

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (1)

AP-HP, Hôpital Européen Georges Pompidou

Paris, France

Location

MeSH Terms

Conditions

Hemoptysis

Interventions

Tranexamic Acid; Terlipressin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Benjamin Planquette, MD, PhD

  AP-HP, Hôpital Européen Georges Pompidou, Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 14, 2021
• Study Start: March 27, 2022
• Primary Completion: December 28, 2025
• Study Completion: March 25, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Teams wishing obtain IPD must meet the sponsor and PI team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasability and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (1)