NCT00302965已完成1 期
Effectiveness of Fresh Frozen Plasma in Critical Care (EPICC) Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- the proportion of patients with a correction of the INR (Determined by the treating physician)
研究概览
简要总结
Measuring the effectiveness of plasma transfusions in critical care
详细描述
Measuring the effectiveness of plasma transfusions in critical care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU Admission
- •INR > 1.2
- •Require FFP for active bleeding and/or prior to an invasive procedure
- •Are able to provide consent or proxy consent
排除标准
- •Congenital or acquired coagulation factor deficiency
- •Platelet count < 50 x 109 /L and have NOT received subsequent platelet transfusion
- •Consumptive coagulopathy (bleeding ≥ 3 sites and ↓ plts, ↓ fib, ↑ d dimer)
- •Uncontrolled bleeding (6 or more units of blood in the last 6 hours)
- •Receiving therapeutic doses of heparin/heparinoid (must be off for at least 6 hours)
- •Have received clotting factor concentrates in the previous 24 hours
- •Are expected to require surgery in the next 48 hours
- •Survival expected to be less than 48 hours
- •Currently enrolled in another study with a similar outcome
- •Previous enrollment in this study
结局指标
主要结局
the proportion of patients with a correction of the INR (Determined by the treating physician)
Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels
bleeding and complications from FFP (fluid overload, transfusion reactions).
次要结局
- Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels
- bleeding and complications from FFP (fluid overload, transfusion reactions).
研究者
研究点 (2)
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