EUCTR2010-022923-31-DE进行中（未招募）1 期
A multicenter double-blind, placebo controlled, randomized, pilot trial to assess the efficacy of pre-hospital administration of Fibrinogen Concentrate (FGTW) in trauma patients, presumed to bleed (FI in TIC) - FI in TIC
Medizinische Universität Innsbruck / Univ.-Klinik für Allgem. u. Chirurg. Intensivmedizin0 个研究点目标入组 67 人开始时间: 2012年12月4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
- 67
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
- •I.1) Trauma patient
- •I.2) Patient at the obvious age of = 18 years of either sex
- •I.3) Major bleeding or occult bleeding
- •I.4) Need for volume replacement therapy
- •I.5) Patient, who will be admitted to one of the participating hospitals
- •Are the trial subjects under 18? no
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •E.1) Solely penetrating trauma
- •E.2) Solely head injury
- •E.3) In case of ongoing severe hemodynamic instability refractory to therapy (vasoressor, volume)
- •E.4) Patient with inevitable lethal course as evaluated by emergency physician
- •E.5) Need for CPR on the scene
- •E.6) Deep hypothermia (<30°C)
- •E.7) Obviously pregnant women
- •E.8) Patient with known recent history of thromboembolic events within the last 6 months
- •E.9) Patient known to be on anticoagulant therapy
- •E.10) Patient with known refusal of a participation in this clinical trial
研究者
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