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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by University of Jena.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00482339
First Posted: June 5, 2007
Last Update Posted: June 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Jena
  Purpose
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.

Condition
Healthy

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood (First Study)

Further study details as provided by University of Jena:

Estimated Enrollment: 2000
Study Start Date: June 2007
Estimated Study Completion Date: July 2009
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy platelet apheresis donor

Exclusion Criteria:

  • Missing health clearance for blood donation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482339


Locations
Germany
Institute for Transfusion Medicine, University Hospital Jena Not yet recruiting
Jena, Thuringia, Germany, D-07743
Contact: Thomas Lorenzen, Dr. med.    +49 3641 935475    thomas.lorenzen@med.uni-jena.de   
Contact: Silke Rummler, Dr. med.    +49 3641 9325593    silke.rummler@med.uni-jena.de   
Sponsors and Collaborators
University of Jena
Investigators
Study Director: Dagmar Barz, Prof Dr med. University Hospital Jena, Germany
  More Information

ClinicalTrials.gov Identifier: NCT00482339     History of Changes
Other Study ID Numbers: ITM-Jena-935035-1
First Submitted: June 4, 2007
First Posted: June 5, 2007
Last Update Posted: June 5, 2007
Last Verified: May 2007

Keywords provided by University of Jena:
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