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NCT00482339 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00482339
Other study ID # ITM-Jena-935035-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 4, 2007
Last updated June 4, 2007
Start date June 2007
Est. completion date July 2009

Study information
Verified date May 2007
Source University of Jena
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Not yet recruiting
Enrollment 2000
Est. completion date July 2009
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- healthy platelet apheresis donor

Exclusion Criteria:

- Missing health clearance for blood donation

Study Design

Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Institute for Transfusion Medicine, University Hospital Jena Jena Thuringia

Sponsors (1)
Lead Sponsor Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

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