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临床试验/NCT03773614
NCT03773614已完成不适用

Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries - a National Study on Injury Prevention

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,000
试验地点
1
主要终点
Presence of impairing illicit and medicinal drugs in blood samples.

研究概览

简要总结

Impairing drugs and alcohol are major risk factors for traumatic injuries. Still there is to date little knowledge to what extent these factors affect the epidemiology of trauma. Detailed mapping of risk factors improve targeting and efficiency of primary injury prevention. The aim of this project is therefore to facilitate injury prevention through improved data collection and analysis on impairing drugs and alcohol as a contributing and modifiable factor in injury morbidity and mortality.

Study question: What is the toxicological profile among patients with suspected severe traumatic injury? Study design: a prospective population-based and national observational study will analyse toxicology from blood samples of all trauma admission during a 12 month study period.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • admission to any Norwegian Trauma Hospital (n=37) AND trauma team activation, during study period

排除标准

  • foreign citizens

结局指标

主要结局

Presence of impairing illicit and medicinal drugs in blood samples.

时间窗: Blood sample are collected at time of hospital admission for each participant. There is only one sample taken from each participant. Samples are consecutively analyzed during the study period.

Impairing substances are reported as nanogram per milliliter. Analysis is performed using liquid chromatography coupled with mass spectrometry.

Presence of alcohol in blood samples.

时间窗: Blood sample are collected at time of hospital admission for each participant. There is only one sample taken from each participant. Samples are consecutively analyzed during the study period. The database is analyzed after study period is completed.

Alcohol is reported in grams per liter. Analysis of alcohol is performed with an automated enzymatic method using alcohol dehydrogenase.

次要结局

未报告次要终点

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Kristiansen

Principal Investigator

Oslo University Hospital

研究点 (1)

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