NCT01287806Unknown2 期
Multicenter,Randomized,Parallel Assignment,Blank Control Study of Ulinastatin in Inhalation Lung Injury
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe inhalation lung injury
- •Within 48hours after inhalation injury
- •Age 18 to 70 years old
- •Burned area not more than 70% TBSA
- •Signed the informed consent form
排除标准
- •Pregnancy or lactation
- •Allergy for ulinastatin
- •Received an investigational drug or device within 90 days prior to entering study
研究组 & 干预措施
blank control group
Sham Comparator
干预措施: blank group (Drug)
ulinastatin group
Experimental
ulinastatin is a multivalent kunitz-type serine protease inhibitor refined from human urine
干预措施: ulinastatin (Drug)
结局指标
主要结局
all cause mortality
时间窗: until death or discharge from hospital, data reviewed every 3 months
次要结局
- length of mechanical ventilation(from admission to 90 days)
- length of ICU stay(until death or discharge from hospital, data reviewed every 3 months)
- length of hospital stays(until death or discharge from hospital, data reviewed every 3 months)
- blood inflammatory mediator(0days,5days and 10days)
- Bronchoscopy morphological evaluation(0days,5days and 10days)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart SurgeryCongenital Heart DiseasesNCT02527811Techpool Bio-Pharma Co., Ltd.450
暂停
4 期
Ulinastatin in Severe Acute PancreatitisPancreatitisNCT01132521Techpool Bio-Pharma Co., Ltd.252
Unknown
2 期
The Effect of Ulinastatin on Bronchoalveolar Lavage Fluid of Inflammatory Factors in Patients With Ventilator-associated PneumoniaVentilator-associated Bacterial PneumoniaMechanical Ventilation ComplicationNCT01865266Shanghai Minhang Central Hospital60
终止
2 期
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational AgeRespiratory Distress Syndrome, NewbornNCT04264156Windtree Therapeutics12
进行中（未招募）
3 期
The effect of ulinastatin on sepsis-related organ failure in childreInfections and InfestationsSepsisISRCTN15982148Guangdong Techpool Bio-pharma Co., Ltd.364