EUCTR2015-000875-28-GB进行中（未招募）1 期
A multi-centre, randomised, double blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage. E-FIT 1 Study - E-FIT 1 v1.0
HS Blood & Transplant0 个研究点目标入组 48 人开始时间: 2015年8月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- •1.Written informed consent or agreement, or waiver of consent, is obtained before any study related activity
- •2.The participant is judged to be an adult (aged 16 years or over) and is affected by traumatic injury
- •3.The participant is deemed by the attending clinician to have on-going active haemorrhage with shock
- •AND REQUIRES:
- •4.activation of the local major haemorrhage protocol for management of severe blood loss and/or transfusion of emergency (Group O) red cells
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1.The participant has been transferred from another hospital
- •2.The trauma team leader deems the patient inappropriate for the trial i.e. injuries deemed to be incompatible with life
- •3.More than 3 hours have elapsed from the time of injury
- •4.The participant is pregnant
- •5.Severe isolated TBI or unsalvageable head injury
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