DRKS00005234招募中2 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 - F1inTIC
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 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 with parameters of shock
- •I.4) Need for volume replacement therapy
- •I.5) Patient, who will be admitted to one of the participating hospitals
排除标准
- •E.1) Penetrating trauma
- •E.2) Solely head injury
- •E.3) In case of hemodynamic instability:
- •Patient has to be excluded if the hemodynamic stabilisation (SBP<110mmHg and
- •HR>100/min) is not achieved after 15 minutes of resuscitation management in spite of volume
- •therapy and administration of catecholamines
- •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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