Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin Versus Placebo in Burn Patients With Inhalation Trauma (Hepburn)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 8
- 主要终点
- Number of ventilator-free days at day 28
研究概览
简要总结
The purpose of this international multi-center double-blind randomized placebo-controlled trial is to determine the effect of nebulized heparin, compared to placebo, on the number of ventilator-free days at day 28, in burn patients with confirmed inhalation trauma requiring mechanical ventilation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age > 18 years
- •Need for invasive mechanical ventilation
- •Confirmed inhalation trauma (bronchoscopically)
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)
研究组 & 干预措施
unfractionated heparin
25.000 IU/5 ml, will be nebulized 4 hourly (i.e. 6 times daily)
干预措施: unfractionated heparin (Drug)
placebo
Sterile sodium chloride (NaCl 0.9%, Pfizer), in 5 ml, will be nebulized every 4 hours (i.e. 6 times daily)
干预措施: placebo (Drug)
结局指标
主要结局
Number of ventilator-free days at day 28
时间窗: at day 28
The number of ventilator-free days is defined as the number of days a patient is breathing without assist of a ventilator during the first 28 days; thus, the patient must be free of mechanical ventilation for 24 hours to have one ventilator-free day; if after successful detubation the patient requires a reintubation due to a surgical procedure, this reintubation will not count as a ventilator day - however, the day(s) will be counted as ventilator day(s) if mechanical ventilation is prolonged after surgery due to respiratory insufficiency.
次要结局
- Clinical outcome parameters(daily or at day 28 and day 90)
- Laboratory outcome parameters(Blood and lavage samples: on admission day and every other day for a maximum period of 14 days)
- Safety parameters(daily, for a maximum period of 28 days)
研究者
Prof. Dr. Marcus J. Schultz
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)