Open Label, Single Center Clinical Trial of a Novel Hemolysis Point of Care Test at an Emergency Department.
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
- 是
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
Lars-Olof Hansson
Clinical chemist, physician.
Landstinget i Värmland
