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PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood

Conditions
Healthy
Registration Number
NCT00482339
Lead Sponsor
University of Jena
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
2000
Inclusion Criteria
  • healthy platelet apheresis donor
Exclusion Criteria
  • Missing health clearance for blood donation

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Institute for Transfusion Medicine, University Hospital Jena

🇩🇪

Jena, Thuringia, Germany

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