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

U

University of Jena

Status

Unknown

Conditions

Healthy

Study type

Observational

Funder types

Other

Identifiers

NCT00482339
ITM-Jena-935035-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy platelet apheresis donor

Exclusion criteria

  • Missing health clearance for blood donation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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