跳至主要内容
临床试验/NCT06219486
NCT06219486招募中不适用

Use of D-dimers in the Emergency Department to Identify Adult Patients at Very Low Risk of Mortality for Fast-track Treatment - a Randomized Controlled Study

Odense University Hospital4 个研究点 分布在 1 个国家目标入组 1,538 人开始时间: 2024年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,538
试验地点
4
主要终点
Length of stay

研究概览

简要总结

Emergency departments (ED) internationally are treating an increasing number of patients.

Most require hospital services but some could be better cared for on alternative pathways.

D-dimer has some unique properties. It is non-specific and is elevated in many acute condi- tions; but conversely remains normal in the absence of significant disease. Previous studies have shown that having a normal D-dimer on arrival to the emergency department is associated with a very low risk of 30-day all-cause mortality.

The investigators propose a multicenter randomized controlled trial using D-dimer to identify patients at low risk and test if providing this information will change time to discharge disposition by the treating physician.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Age 18 or above
  • Able to provide oral and written informed consent in Danish
  • Blood tests ordered on arrival as part of standard of care
  • Ambulatory on arrival or walking to the ambulance (i.e., stable independent gait)
  • Normal vital signs (i.e., National Early Warning Score < 3)

排除标准

  • Unstable condition requiring immediate care in the resuscitation area
  • Triage level red (i.e., the most urgent patients)
  • Trauma (minor and major) patients
  • High likelihood of requiring a D-dimer analysis on clinical indications during the current hospital contact (e.g., suspected venous thromboembolic disease) that will be ordered on arrival regardless of this study
  • Previous participation in the study

结局指标

主要结局

Length of stay

时间窗: From arrival to physician decision within 4 hours of arrival

Length of initial emergency department stay (i.e., time from arrival to the emergency department to decision to discharge home or transfer to another department is made (as reported from the treating physician to the study nurse)).

次要结局

  • Hospital length of stay(From arrival until final discharge within 1 month)
  • Re-contacts to the emergency department within 30 days from arrival for any reason(From arrival until 30-days later)
  • 7- and 30-day all-cause mortality from arrival(From arrival until 30-days later)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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