The main goal is to establish reference values of new clinical laboratory tests
ID
Source
Brief title
Condition
- Other condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Health condition
Referentiewaarden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints include the establishment of reference intervals for
new clinical laboratory tests in healthy volunteers
Secondary outcome
Not applicable
Background summary
Synapse Research Institute and the pharmaceutical laboratory, Diagnostica Stago
S.A.S., which works in the in vitro diagnosis industry, wholly dedicated to the
exploration of haemostasis and thrombosis developped several new assays and
devices for studying haemostasis. Before these devices and assays can be used
in practice in clinical laboratories, reference values in healthy volunteers
need to be determined. In the future, these reference values will be supplied
to customers as they are the most common decision support tool used for
interpretation of clinical laboratory tests and thereby essential for patient
care.
Study objective
The main goal is to establish reference values of new clinical laboratory tests
Study design
This study is an observational study in which blood will be drawn from healthy
control volunteers by venapunction. Blood will be drawn from healthy volunteers
(maximum 200/year) toestablish reference intervals of new clinical laboratory
tests. This study will be conducted within 5 years.
Study burden and risks
Participation in this study involves drawing blood from healthy individuals by
venipuncture. The burden and risks are minimal.
allée Thérésa 3
Asnières sur Seine 92665
FR
allée Thérésa 3
Asnières sur Seine 92665
FR
Listed location countries
Age
Inclusion criteria
Healthy men and women >=18 and < 65 years old
Signed written consent to take part in the study
Exclusion criteria
Clinical pathology known to have links with coagulation disorders
Treatments likely to interfere with coagulation
Pregnant women or immediately post-partum (3 months)
Design
Recruitment
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 | NL73968.068.20 |