National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 39
- 主要终点
- use of rFVIIa in haemorrhagic trauma compared to guidelines
研究概览
简要总结
The rFVIIa (Novoseven) has been tested in traumatic hemorrhage but its efficiency has not been proven yet in this context. A national register has been set up in France identifying the patients which received rFVIIa.
Those patients had persistent and active bleeding after severe trauma despite surgery and/or interventional radiology embolization.
The aim of this present study is to report the first clinical results in those situations of patients treated with rFVIIa.
详细描述
It consists of a study of a prospective cohort in 36 centers, for 3 years, from April 1st 2008. The data of all patients who received rFVIIa in traumatic situation were collected. The investigators colligated clinical and biological parameters; have been analyzed treatment received during initial care, in intensive care before and after they received rFVIIa, length of stay in ICU, secondary effects, complications and patients outcome.
ISS and TRISS score were calculated to predict mortality.
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
- •people affiliated to social security
- •patients admitted in ISU for haemorrhagic trauma
- •patients received rFVIIa after the other treatment for bleeding control
排除标准
- •allergy or hypersensitivity to rVIIa or one of its component
结局指标
主要结局
use of rFVIIa in haemorrhagic trauma compared to guidelines
时间窗: twenty four hours
Deviations with European guidelines use of rFVIIa
次要结局
- security and efficiency use of rFVVa(thirty days)
- medico economic evaluation(one year)