ISRCTN15731357已完成2 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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •1. Adult trauma patients (16 years and above).
- •2. Activation of the local massive haemorrhage protocol
- •3. Patients with active, ongoing haemorrhage
- •4. Agreement for participation is provided on behalf of incapacitated patients by Personal Consultee or Nominated Consultee (i.e. trauma team leader)
排除标准
- •1. Time of admission more than 2 hours after the time of injury
- •2. Time of drug administration not attainable within 4 hours of injury
- •3. Subject not expected to survive more than 48 hours
- •4. Evidence of severe traumatic brain injury (GCS 3 at scene)
- •5. Known pregnancy
- •6. Suspected non-haemorrhagic cause of shock
- •7. Massive haemorrhage protocol activation more than one hour after arrival
- •8. Concurrent participation in another Clinical Trial of an IMP
- •9. Breastfeeding females
- •10. Known allergy to Artesunate
研究者
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