Shock Index To DEtect Low Plasma Fibrinogen In Trauma (SIDE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Proportion of subjects that have plasma fibrinogen <2.3 g.l-1 on admission among those with shock-index >1.
研究概览
简要总结
Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without the need to perform other potentially time consuming investigations.
详细描述
Hypofibrinogenemia is common in severe trauma and below the threshold of 2.3 g/l is associated with increased mortality. Although guidelines for management of the trauma induced coagulopathy does not recommend any specific timing of fibrinogen substitution, several papers suggest that early substitution might be associated with improved outcome. Laboratory measurement of plasma fibrinogen level, thromboelastometry and/or its estimation based on base excess, hemoglobin level, Injury Severity Score or combinations require diagnostic procedures that are associated with with a certain time delay and prolongs the time to fibrinogen substitution.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patient having / suspected to have severe trauma transported to participating centers by cooperating Emergency Medical System organizations
排除标准
- •possible alterations of plasma fibrinogen level in the time of trauma (inflammatory disease, malignant disease, pregnancy)
- •administration of fibrinogen containing products (fresh frozen plasma, fibrinogen concentrate, cryoprecipitate) before sampling blood for fibrinogen level
- •circumstances possibly interfering with plasma fibrinogen level measurement (prior the administration of hydroxyethylstarches)
结局指标
主要结局
Proportion of subjects that have plasma fibrinogen <2.3 g.l-1 on admission among those with shock-index >1.
时间窗: On admission
次要结局
未报告次要终点
研究者
Josef Skola
Dr.
Masaryk Hospital Krajská zdravotní a.s.