Innovative methodology: the developement of a micro-array flow device

In the present study it is the goal to develop a micro- array base flow device
while ccurrently available assays suffer from one more of the following
shortcomings. This includes low detection power, lack of specificity for the
disease, lack of detection sensitivity, high costs, long handling procedure and
laboriousness. Also, many of the newly developed tests are too expensive to be
applied in general practice (outside the research laboratory). These technical
and feasibility limitations have no doubt hampered the diagnostic application
in patients at risk. As a consequence, in spite of the vast knowledge of
mechanisms implicated in thrombosis and bleeding, we still lack suitable tools
to assess the disease state in an individual patient. It is therefore important
to combine all available knowledge and technical expertise to develop a
suitable diagnostic platform, where most or all of these limitations are
overcome

Primary objective:
The main purpose of the study is to develop a new concept of micro-based flow
devices to detect (i) a prethrombotic state, (ii) the efficacy of established
and novel antithrombotic medication, (iii) insufficient hemostasis and bleeding
risk, or (iv) efficacy of treatment with platelets or coagulant factors in case
of bleeding. This goal is achieved in a two-step approach: Phase 1:
establishment of optimal experimental conditions; phase 2: determination of
inter- and intra-subject variability of flow-dependent thrombus formation at
optimized conditions.

This study is an invasive observational design. However, the impact on the
subjects will be minimal. Blood will be drawn from healthy volunteers (male and
female) between the ages of 18 and 65 years. They will be recruited from
Maastricht University and Maastricht UMC+. Before blood collection an informed
consent will be signed.
In the first phase of this study subjects will give blood at one
time-point. In the second phase measurements will be performed at 3 different
time points. In all cases, two tubes of 9 mL blood will be drawn for the flow
experiments, while two other tubes of 9 mL blood are taken for control
experiment for assessment of platelet and coagulation function (routine
aggregation, signaling and flow cytometric determinations).

The venipunctures will be made by experienced coworkers. Nevertheless, blood
sampling causes local bruising, and incidentally a hematoma can be formed.
There will be no direct benefit of the subjects.