EUCTR2012-003289-42-NL进行中（未招募）不适用
Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin versus Placebo in Burn Patients with Inhalation Trauma - Hepburn study
Academic Medical Center Amsterdam0 个研究点目标入组 118 人开始时间: 2012年12月21日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 118
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
- •- informed consent
- •- age > 18 years
- •- need for invasive mechanical ventilation
- •- clinical diagnosis of inhalation trauma: initially on basis of indirect observations, followed by confirmation through bronchoscopy
- •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 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •- > 36 hours after trauma
- •- Receiving invasive ventilation > 24 hours
- •- Expected duration of mechanical ventilation < 24 hours
- •- Chronic obstructive pulmonary disease GOLD stage III and IV
- •- Any history of pulmonary hemorrhage in the past 3 months
- •- Any history of significant bleeding disorder
- •- Known allergy to heparin, including heparin–induced thrombocytopenia
- •- Pregnancy or breast feeding
- •- Unlikely to survive for > 72 hours
- •- Total body surface area (TBSA) > 60%
- •- Witnessed or proven aspiration (i.e., confirmed by bronchoscopy)
研究者
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