EUCTR2015-000301-40-GB进行中（未招募）1 期
A randomised, blinded, placebo-controlled Phase 2a study to evaluate the safety and efficacy of Artesunate treatment in severely injured trauma patients with traumatic haemorrhage. - Trauma Organ Protection - Artesunate (TOP-ART)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
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
入选标准
- •A patient will be eligible for the study if they meet the following criteria;
- •Adult trauma patients
- •Activation of the local massive haemorrhage protocol
- •Patients with active, ongoing haemorrhage
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •The principle exclusion critieria include:
- •Patients not expected to survive >48 hours
- •Patients with evidence of severe traumatic brain injury (GCS 3 at scene)
- •Known pregnancy
- •Suspected non-haemorrhagic cause of shock
- •Massive haemorrhage protocol activation >1 hour after arrival
- •IMP administration not attainable within 4 hours of injury
- •Admission greater than 2 hours post injury
- •Breastfeeding
研究者
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