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临床试验/NCT00482339
NCT00482339Unknown不适用

PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood (First Study)

University of Jena1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1

研究概览

简要总结

Using methods of molecular biology bacteria can be detected in blood. In comparison to conventional blood cultures "bacterial DNA" is isolated using a new sample preparation system in platelet apheresis concentrates and in the predonation whole blood of donors.

详细描述

Bacterial contamination of platelet concentrates is discussed worldwide and according to literature occuring in 1:1000 to 1:5000 concentrates. Bacterial contaminated concentrates can in fact cause severe infections in patients. therefore this study initially intends to detect contamination with "bacterial DNA" in platelet aphereses concentrates. All sample donations are also examined by blood culture for contamination. To exclude already existing "infection" of the donor one tube of whole blood is taken in addition to the other legally required samples for the production of pharmaceutical medicine. All samples are anonymised before passed on for analysing.

研究设计

研究类型
Observational
时间视角
Other

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy platelet apheresis donor

排除标准

  • Missing health clearance for blood donation

研究者

发起方
University of Jena
申办方类型
Other

研究点 (1)

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