ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 2
- 主要终点
- Number of patients with complete or partial resolution of hemoptysis without the use of any interventional procedure.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Normal Saline Placebo
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.
干预措施: Placebo (Drug)
Tranexamic Acid
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.
干预措施: Tranexamic Acid 500 MG (Drug)
Terlipressin
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
干预措施: Terlipressin (Drug)
结局指标
主要结局
Number of patients with complete or partial resolution of hemoptysis without the use of any interventional procedure.
时间窗: 3 days
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
次要结局
- Rate of in-hospital mortality(30 days)
- Time between hospital admission and bronchial arterial endovascular embolization(3 days)
- Rate of patients with hemoptysis recurrence(30 days)
- Rate of patients with total volume of hemoptysis < 200 ml(3 days)
- Rate of patients who need a mechanical ventilation(3 days)
- Rate of specific adverse events(3 days)
- Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization)(3 days)
- Rate of partial resolution of hemoptysis defined as recurrence < 50 ml(3 days)
- Rate of complete resolution of hemoptysis within 3 days, as previously defined(3 days)
- Death rate(30 days)