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临床试验/NCT03572309
NCT03572309已完成不适用

Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen

Masaryk University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Trauma induced coagulopathy

研究概览

简要总结

The purpose of the study is to find out the incidence of trauma induced coagulopathy in patients with severe trauma who received fibrinogen prior admission to emergency department during prehospital care.

详细描述

The study will commence following the Approval by The Ethics Research Committee. All patients admitted to emergency department during the study will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. After admission to emergency department the blood samples will be taken and blood tests and viscoelastic tests will be performed. All data and results will be entered in the study form. Statistical analysis will be performed and incidence of trauma induced coagulopathy estimated. In addition, 28-day mortality and the incidence of thromboembolic complications will be monitored.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • multiple trauma, injury severity score (ISS) ≥16
  • administration of fibrinogen in prehospital care
  • age 18-80 years

排除标准

  • pregnancy
  • therapeutic anticoagulation
  • therapeutic antiaggregation

结局指标

主要结局

Trauma induced coagulopathy

时间窗: day of enrolment

Incidence of trauma induced coagulopathy

次要结局

  • 28day mortality(28 days after enrolment)
  • thromboembolic complications(28 days after enrolment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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