Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482339
Status:
UNKNOWN
Last Update Posted:
2007-06-05
First Post:
2007-06-04
Brief Title:
PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood
Sponsor:
University of Jena
Organization:
University of Jena
Study Overview
Official Title:
PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood First Study
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11000 to 15000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None