Hyperfibrinogenemia Within the First Days After Major Trauma : Kinetic, Functionality, Impact of Fibrinogen Replacement Therapy and Trauma, Thrombosis Risk
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- daily fibrinogen level >4 g/L
研究概览
简要总结
Assessment of the evolution of fibrinogen plasma level within the first ten days after major trauma in order to determine prevalence of hyperfibrinogenemia (Fg > 4 g/L) and its time to onset.
详细描述
In this study, investigators daily investigate fibrinogen plasma levels and fibrinogen antigen in severe trauma patients (Injury severity score > 15) within the first ten days. Investigators then modelize hyperfibrinogenemia profiles according to severity of injuries and physiopathologic mechanisms. Finally, investigators determine predisposing risk factors to develop hyperfibrinogenemia and assess the impact of fibrinogen replacement therapy in initial phase of management of major trauma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years old.
- •Polytrauma with ISS Score > 15
- •Hospitalized patients in reanimation unit < 4h after trauma
- •Informed consent
排除标准
- •Patients in another study
- •Pregnant or lactating women
结局指标
主要结局
daily fibrinogen level >4 g/L
时间窗: 10 days
the occurrence and delay of fibrinogen level \> 4 g/L after major trauma
次要结局
- assessing predisposing risk factors of hyperfibrinogenemia (> 4 g/l)(10 days)
- plasmatic fibrinogen level evolution(10 days)