HealthyNCT00482339
PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood
An observational study of Healthy, run by University of Jena at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy platelet apheresis donor
Who cannot join
- Missing health clearance for blood donation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Transfusion Medicine, University Hospital Jena
Jena, Thuringia, D-07743
Thomas Lorenzen, Dr. med., +49 3641 935475, thomas.lorenzen@med.uni-jena.de
Silke Rummler, Dr. med., +49 3641 9325593, silke.rummler@med.uni-jena.de
About this study
Official title: PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood (First Study)
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.
Read the 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.
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startJun 2007
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Investigators
- Dagmar Barz, Prof Dr med., Study director, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482339
- Sponsor's protocol ID
- ITM-Jena-935035-1
- Status last verified
- May 2007
- First submitted
- 4 Jun 2007
- Last updated
- 5 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood (First Study)
- ClinicalTrials.gov ID
- NCT00482339
- Acronym / sponsor ID
- ITM-Jena-935035-1
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Jul 2009 (estimated)
- First posted
- 5 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy platelet apheresis donor
Key exclusion criteria (1 listed)
- Missing health clearance for blood donation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Institute for Transfusion Medicine, University Hospital Jena
Jena, Germany
Dagmar Barz, Prof Dr med. study director
Jena University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2007.