跳至主要内容
临床试验/NCT01357928
NCT01357928已完成不适用

Procedure for the Reference Range Study for Haemoscope Reagents

Haemonetics Corporation1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
1

研究概览

简要总结

As part of a system wide reagent verification plan Haemoscope Corporation will be running a study to verify the reference intervals of many of the reagents. Reference intervals will be constructed following the guidelines set out in CLSI document C28-A3c. This guideline calls for a reference interval to be constructed from at least 120 donors. Some reagents currently have ranges in place based on fewer donors than that stated in the guideline. This procedure will provide additional testing results to meet the requirements outlined in the CLSI guideline. Reagents that currently have no reference intervals will be tested and will include a minimum of 146 donors.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or Female over the age of 18 years.

排除标准

  • Genetic bleeding disorders
  • Currently Pregnant
  • Oral Contraceptives
  • On anti-coagulants or anti-platelet therapy
  • Took ASA (Acetylsalicylic Acid)within 1 week prior
  • Recent surgery (within 4 weeks)
  • Recent injury leading to substantial bruising (within 2 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验