Hemoptysis Clinical Trial
— ACTIVEOfficial title:
ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | AP-HP, Hôpital Européen Georges Pompidou | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Ministry of Health, France |
France,
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 |
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