The objective of this pilot study is to assess whether transportation of the sample via a pneumatic tube system (PTS) has any detrimental effects on the recovery of presepsin levels, when compared to traditional hand-delivery. This research will be…
ID
Source
Brief title
Condition
- Infections - pathogen unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The slope of the linear regression line of the presepsin concentrations
measured after the two transport methods should be within a clinically
reasonable range (slope 1.00 ± 0.15, and/or the correlation (Pearson*s r) >
0.900). After evaluating the results of the first 45 samples (equally
distributed between the three concentration ranges), if the outcome is
negatively conclusive, the study can stop, otherwise the collection of samples
shall continue until up to 130 results approximately equally distributed
between the given sample ranges are reached. Due to the desire for an even
distribution, a maximum of 200 subjects are included.
Secondary outcome
The measured concentrations of presepsin immediately after arrival are compared
with the measured concentrations of presepsin at two time points the next day.
This determines the stability at room temperature.
Stability is determined by:
Absolute deviation: recovery concentration Presepsin <= 500 pg/mL: +/- 50 pg/mL
Relative deviation: Presepsin > 500: +/- 10%
Background summary
The Elecsys® Presepsin assay is an immunoassay utilizing the
electrochemiluminescence »ECLIA« technology for
the quantitative in vitro measurement of presepsin in human serum and plasma.
The test uses two monoclonal antibodies specifically directed against
presepsin.
This study is being conducted to obtain information on transport and
temperature stability at room temperature as part of the technical validation
to be able to obtain future approval for use of Elecsys® Presepsin in clinical
practice by the regulatory authorities.
Study objective
The objective of this pilot study is to assess whether transportation of the
sample via a pneumatic tube system (PTS) has any detrimental effects on the
recovery of presepsin levels, when compared to traditional hand-delivery. This
research will be carried out in three types of materials (serum, heparin plasma
and EDTA plasma), of each type two tubes will be collected.
The secondary (optional) objective is to test the room temperature stability of
presepsin.
Study design
Prospective, non-interventional, observational, multicenter study enrolling
patients with no, beginning or clear signs of infection/sepsis.
Study burden and risks
The burden amounts to taking a maximum of 2x 30 ml during two planned
bloodwithdrawls during regular care. The only risks of the study are the
possible side effects of a venipunture.
Sandhofer Strasse 116
Mannheim 63805
DE
Sandhofer Strasse 116
Mannheim 63805
DE
Listed location countries
Age
Inclusion criteria
Signed Informed Consent
Age >= 18 years
To obtain higher concentrations of presepsin: characteristics of infection,
high CRP or PCT values in plasma.
Exclusion criteria
Self-declared pregnancy or breast-feeding women.
Dependent of sponsor or investigator.
Known/self-declared anemia.
Cognitive impairment.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87568.000.24 |