EUCTR2020-005931-58-FR进行中（未招募）1 期
ACTIVE : ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis - ACTIVE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 315
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients over 18 years, under 90 years
- •- Mild to severe hemoptysis that has been going on for less than 72 hours
- •- 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 190
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)
- •- Absolute need for anticoagulant treatment at curative dosage (recent venous thrombo-embolism in the 6 past months)
- •- Known hypersensitivity to TXA or TER or one of its excipients
- •- Contraindication to TXA 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
研究者
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