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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515010-40-00
Acronym
APHP200043
Enrollment
315
Registered
2024-10-09
Start date
2022-03-28
Completion date
Unknown
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Detailed description

Rate of complete resolution of hemoptysis within 3 days, as previously defined, Rate of partial resolution of hemoptysis defined as recurrence < 50 mL within 3 days, as previously defined, Proportion of patients with total volume of hemoptysis < 200 mL within 3 days, Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization) within 3 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.

Interventions

DRUGNaCl 0.9%
DRUGTRANEXAMIC ACID
DRUGTERLIPRESSIN

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Rate of complete resolution of hemoptysis within 3 days, as previously defined, Rate of partial resolution of hemoptysis defined as recurrence < 50 mL within 3 days, as previously defined, Proportion of patients with total volume of hemoptysis < 200 mL within 3 days, Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization) within 3 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.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026