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临床试验/NCT04471688
NCT04471688Unknown不适用

Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion

The Third Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10,000
试验地点
1
主要终点
Hepatitis C Infection Analysis result

研究概览

简要总结

In the past ten years, nucleic acid detection technology has overcome the limitations of serological detection, reduced missed detections due to window period, occult infection, etc., and its application in the field of pathogen detection has developed rapidly. Since 2015, domestic blood collection and supply institutions have fully popularized nucleic acid testing. The safety screening of blood sources mostly adopts the method of combining two times of enzyme-free negative and one time of nucleic acid testing, which excludes the guarantee of blood safety to the greatest extent.

At present, the clinical pre-transfusion and pre-operative infectious disease screening in our country is still serological detection. The use of nucleic acid detection for infectious disease screening can better realize the significance of patients' pre-transfusion/pre-operative infectious disease screening. Therefore, this study will analyze the nucleic acid detection technology and clinical serological detection technology in order to solve three problems:

  • Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening; ② Explore the confirmation process of the gray area results of infectious disease serological testing; ③ Better realize the significance of screening for patients' infectious diseases.

研究设计

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

入排标准

年龄范围
1 Year 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • hosipital patients

排除标准

  • 未提供

结局指标

主要结局

Hepatitis C Infection Analysis result

时间窗: 20190601-20201231

Nucleic acid examination and serological test

HIV Infection Analysis result

时间窗: 20190601-20201231

Nucleic acid examination and serological test

Hepatitis B Infection Analysis result

时间窗: 20190601-20201231

Nucleic acid examination and serological test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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