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.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- 性别
- All
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.
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