EUCTR2004-000088-92-ES
进行中（未招募）
1 期
A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa (NovoSeven®/Niastase®) with Brain Contusions.
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Contusive Brain Injury
- 发起方
- ovo Nordisk A/S
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Informed consent obtained before any trial\-related activities.
- •\- Contusive brain injury (including brain stem) diagnosed by clinical examination and CT scan within 4 hours of onset.
- •\- Head CT scan showing at least one single intraparencymal haemorrhage (contusion) with a total minimum volume of greater than or equal to 5 ml as detected by the ABC/2 method.
- •\- Male of female subjects, age 18 years or over.
- •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
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
排除标准
- •\- Life expectancy less than 24 hours after injury.
- •\- Any planned intraparenchymal brain surgery within 24 hours of dosing.
- •\- Time of CBI unknown or \> 4 hours prior to initial CT scan.
- •\- Penetrating brain injury.
- •\- Body weight greater than or equal to 160 kg.
- •\- Spinal cord injury.
结局指标
主要结局
未指定
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