跳至主要内容
临床试验/CTRI/2020/07/026640
CTRI/2020/07/026640尚未招募不适用

A pilot study on screening of blood donors for emerging transfusion transmissible Leptospirosis infection in an endemic area.

Directorate of Research Manipal Academy of Higher Education1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年7月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
The prevalence of leptospirosis infection would be studied, and the need for implementation of screening test for blood components.

研究概览

简要总结

Emerginginfectious diseases pose threats to the general human population, includingrecipients of blood transfusions. The risk of transmission of infection byblood transfusion results from collecting of blood from an infected donor whilehe is asymptomatic and the pathogen is present in his blood. Themicrobiological safety of the blood supply is continuously improving. The majorfocus has been HIV, hepatitis viruses and bacterial contamination. In fact,there are many infectious agents that are known, or that have properties thatwould predict the ability, to be transmissible by blood transfusion. A recent publicationlisted some 68 infectious agents with this characteristic, but for whichinterventions have not been implemented. [1] Leptospirosis is among suchinfections and is endemic in Karnataka and Kerala and we have outbreaks of Leptospirosisalmost every year. The present study is planned to assess the need forimplementation of newer donor screening strategies for detection ofleptospirosis infection at our place. A prospective pilot studyenrolling 500 healthy voluntary blood donors will be done. The donor samplewill be collected after blood donation from the blood bag for screening oftransfusion transmissible infections (HIV, HBV, HCV, Malaria and Syphilis). Inaddition to these mandatory screening tests we will be screening the sample forLeptospirosis infection by detection of leptospira specific Ig M antibodies byELISA method. If a donor is found to be reactive, a confirmatory test would beperformed by rapid kits and donor notification and the components prepared willbe discarded

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Blood donors who are residents of Udupi district only will be included.

排除标准

  • Blood donors form other districts will be excluded.

结局指标

主要结局

The prevalence of leptospirosis infection would be studied, and the need for implementation of screening test for blood components.

时间窗: March 30 2020

次要结局

  • the need for larger studies to evaluate the necessity of implementation of screening test for blood components.(December 31 2020)

研究者

发起方
Directorate of Research Manipal Academy of Higher Education
申办方类型
Research institution

研究点 (1)

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