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临床试验/NCT02976610
NCT02976610已完成不适用

Open Label, Single Center Clinical Trial of a Novel Hemolysis Point of Care Test at an Emergency Department.

Hemcheck Sweden AB2 个研究点 分布在 1 个国家目标入组 1,671 人开始时间: 2016年12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
1,671
试验地点
2
主要终点
Hemolysis frequency.

研究概览

简要总结

This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of care test is introduced in an emergency department.

详细描述

In a blood sample process, the preanalytical phase is accountable for a vast majority of laboratory test errors. Among preanalytical errors, hemolysis is the most frequent error of sample rejection. Recollection of blood from the patient causes extra suffering, increased turn-around-time hence delayed treatment, and unnecessary extra costs for the health care system.

Here is a novel method for hemolysis point of care detection (H-POCT) evaluated. The single use test is attached to the blood sample in direct conjunction to the sampling process.

Patients will be selected by consecutive selection at the emergency department if blood tests ordered by the physician meet the inclusion criteria. Patients will be randomized into one of two groups. All health care professionals participating in this study has attended in a standard education program in operating H-POCT.

If Allocated into the control group, n: 750, nurses and enrolled nurses will perform blood sample according to routine.

If allocated into the intervention group, n: 750, nurses and enrolled nurses will perform blood sample according to routine and screen all Lithium Heparin vacuum tubes. (for one or all of the analyzes: Liver status, Electrolytes and Troponin T.)

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

  • Blood sample analysis ordered:
  • Electrolyte
  • Troponin T
  • ALAT, ASAT, ALP.

排除标准

  • Incompletely filled tubes
  • Minors (< 18 years)
  • Patient not fit according to the health care professional assessment

结局指标

主要结局

Hemolysis frequency.

时间窗: Through 52 weeks

Compare the volume of hemolyzed blood samples in two groups.

次要结局

未报告次要终点

研究者

发起方
Hemcheck Sweden AB
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Lars-Olof Hansson

Clinical chemist, physician.

Landstinget i Värmland

研究点 (2)

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