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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by University of Jena.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT00482339
First received: June 4, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy platelet apheresis donor

Exclusion Criteria:

  • Missing health clearance for blood donation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00482339     History of Changes
Other Study ID Numbers: ITM-Jena-935035-1
Study First Received: June 4, 2007
Last Updated: June 4, 2007
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on October 23, 2014