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临床试验/NCT03601221
NCT03601221已完成不适用

Observational Study on Seroprevalence of Hepatitis E Infection in Healthy Blood Donors in the Canton Ticino

Ente Ospedaliero Cantonale, Bellinzona1 个研究点 分布在 1 个国家目标入组 1,447 人开始时间: 2018年5月29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
1,447
试验地点
1
主要终点
HEV blood incidence

研究概览

简要总结

This is a HEV seroprevalence in the health donors in the Canton Ticino study. The pre-donation sampling pouch of each blood donor coming form the Cantone Ticino region will be collected and tested for HEV serology (IgM and IgG).

详细描述

Pre-donation sampling pouch of fresh and stored frozen plasma collected within the last 5 years will be tested for HEV IgG serology at the National Reference Laboratory of the Blood Transfusion Services SRC in Berne Collected data will be used to determine HEV seroprevalence, actual and in the last 5 years, in the Canton Ticino and to investigate trend and pattern of the HEV infection (seroprevalence by different regional areas, comparison with national HEV data, and correlation with age, sex and place of residence).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Healthy and voluntary blood donors
  • Subjects living in the Canton Ticino
  • Inclusion criteria for blood donation
  • Signed informed consent of the STCRS SI for blood donation

排除标准

  • Exclusion criteria for blood donation

结局指标

主要结局

HEV blood incidence

时间窗: One year

HEV incidence assessed through a single periferal blood sample from each donor

次要结局

  • change in the blood incidence of HEV(Five years)
  • Geogarphical distribution of the HEV measured in the blood sample(Five years)
  • Trend of the HEV infection measured in the blood sample(One year)

研究者

发起方
Ente Ospedaliero Cantonale, Bellinzona
申办方类型
Other
责任方
Sponsor

研究点 (1)

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