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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00482339
Enrollment
2000
Registered
2007-06-05
Start date
2007-06-30
Completion date
2009-07-31
Last updated
2007-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

bacterial contamination, platelet concentrates, blood donation, looxster, pureprove, bacterial genomic DNA, bacterial contamination of platelet concentrates, Preparation of bacterial DNA in blood, comparison of blood culture versus NAT

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.

Interventions

None listed

Sponsors

University of Jena
Lead SponsorOTHER

Study design

Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy platelet apheresis donor

Exclusion criteria

* Missing health clearance for blood donation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026