AcTIVE - ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis: a randomized Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

28 Mar 2022 → 28 Jan 2026

Decision date (initial)

2024-10-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515010-40-00

EudraCT number

2020-005931-58

ClinicalTrials.gov

NCT04961528

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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 3 days of hospitalization.
Using a hierarchical analysis, the comparison between TXA and TER will be tested once superiority on efficacy of both inhaled TXA and TER groups vs placebo group is demonstrated. If the first step is unsuccessful, TXA versus TER comparison will be regarded as exploratory.

Secondary objectives 2

1. 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 The above secondary objectives will also be assessed for the comparison of TXA versus TER.
2. The identification of risk factors for hemoptysis recurrences will also be assessed.

Conditions and MedDRA coding

Hemoptysis, whatever the cause, with the exception of cystic fibrosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients over 18 years, under 90 years
2. Mild to severe hemoptysis that has been going on for less than 7 days
3. Total expectorate blood ranging from 50 ml to 200 ml
4. Admission in emergency department or ICU for less than 12 hours
5. Social security affiliation
6. Signed informed consent
7. For child-bearing aged women, efficient contraception includes oral oestrogen-progestin, oral progestin, progestin implants and all types of intrauterine devices

Exclusion criteria 9

1. Need for mechanical ventilation
2. Cystic fibrosis
3. Pregnancy or breast feeding
4. Contraindication for contrast agents injection (renal failure with creatinin clearance < 30ml/min, know allergy to contrast agents injection)
5. Known hypersensitivity to TXA or TER or one of its excipients
6. Know previous cardiac arrhythmia (atrial fibrillation, atrial flutter..)
7. 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
8. Participation in another interventional study or being in the exclusion period at the end of a previous study
9. Patient under tutorship or / guardianship, and incapable to give informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 3 days; partial resolution is defined as hemoptysis recurrence < 50 mL within the first 3 days.

Secondary endpoints 9

1. Rate of complete resolution of hemoptysis within 3 days, as previously defined
2. Rate of partial resolution of hemoptysis defined as recurrence < 50 mL within 3 days, as previously defined
3. Proportion of patients with total volume of hemoptysis < 200 mL within 3 days
4. Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization) within 3 days
5. Time between hospital admission and endovascular treatment
6. In-hospital mortality
7. 30-day rate of patients with hemoptysis recurrence
8. 30-day mortality
9. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Vincent ROTHSTEIN

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Vincent ROTHSTEIN

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications