NCT05376462终止不适用
An Interventional Randomized Controlled Trial of the Quantra® System With the QStat® Cartridge in Trauma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Total units of red blood cells (RBC) transfused
研究概览
简要总结
This is a prospective, single-center, observational study to assess the Quantra QStat System in trauma patients.
详细描述
This is a prospective, single-center, observational study to assess the performance of the Quantra QStat System in trauma patients.
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
- •Subject is > 18 years; Children under the age of 18 are protected by adults under guardianship or by court order.
- •Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response according to site's level 1of trauma team activation criteria.
- •Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent.
- •Exclusion Criteria
- •Subject is pregnant.
- •Subject is currently enrolled in a distinct study that might confound the result of the proposed study.
- •Subject is not covered by social security.
排除标准
- 未提供
结局指标
主要结局
Total units of red blood cells (RBC) transfused
时间窗: 24 hours post-presentation for trauma subjects
The primary endpoint of Phase II will be the total units of red blood cells (RBC) transfused and administered 24 hours post-presentation for trauma subjects.
次要结局
- Total number of units (cc) of platelets, fibrinogen, fresh frozen plasma and TXA transfused(48 hours after admission to the hospital)
研究者
研究点 (1)
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