The main objective is to determine the effect of different anticoagulant and procoagulant agents on thrombin generation in whole blood and compare it to the effect on thrombin generation in PPP and PRP at different tissue factor concentrations. In…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Thrombin generation will be determined in PPP, PRP and whole blood with or
without flow. The data that will be collected through these experiments will be
analysed with the use of 4 parameters: endogenous thrombin potential (ETP),
peak height, time to peak and lag time. The thrombin generation experiments
will be performed in the absence and presence of anticoagulant agents or agents
that will possibly affect thrombin formation. If necessary, clotting factor
determinations will be performed on the stored PPP, these can be antigen
determinations or functional determinations.
Control experiments need to be carried out in order to check the quality of the
blood/plasma by using the standard procedures of the lab: e.g. cell count, flow
cytometry, aggregometry, clotting*
Secondary outcome
NA
Background summary
Thrombin generation is becoming an increasingly important tool to measure the
variables of the clotting system. We can not only use thrombin generation
testing to evaluate the coagulation system of a person, but we can also add
different agents to the test in order to evaluate the effect on an individual*s
plasma. The effect of anticoagulant and procoagulant agents has already been
investigated by using Calibrated Automated Thrombography (CAT) in plasma.
However, Synapse bv also developed a method for measuring thrombin generation
in whole blood and a method for measuring thrombin generation under flow.
Consequently, we want to compare the effect of different anticoagulant and
procoagulant agents in platelet poor, platelet rich plasma (PPP, PRP) and whole
blood.
Study objective
The main objective is to determine the effect of different anticoagulant and
procoagulant agents on thrombin generation in whole blood and compare it to the
effect on thrombin generation in PPP and PRP at different tissue factor
concentrations. In other words, we want to validate the whole blood CAT assay
by comparing it to the CAT in plasma. We would also like to measure thrombin
generation and viscosity under flow conditions resembling shear rates in in
vivo venous and arterial blood flow.
The secondary objective is to determine the inter-individual variability in
response to the different agents.
Study design
This study is of invasive design. Yet, the impact will be minimal for the
subjects. A venipuncture will be performed in healthy volunteers (male and
female) between the ages of 18 and 65 years. Before blood collection an
informed consent form will be signed. An estimated 175 blood donations will be
needed over a period of 4 years. A donor will be asked to participate in the
study one time, which means that he/she will undergo only one blood draw.
The study aims to compare thrombin generation with or without agents with an
anticoagulant or procoagulant effect. This will be done in PPP, PRP and whole
blood of healthy donors with or without flow. In this way we can compare the
effect of agents in whole blood to that in PPP and PRP. The duration of the
study for each individual subject will be limited to a few minutes.
We would like to add different anticoagulant or procoagulant agents to the
blood and plasma of each subject, though it is not possible to add all agents
which we want to investigate. For this reason we opt to add 3 agents to the
blood/plasma of one subject. This means that we need three tubes or 30 ml of
citrated blood per subject, so 27 ml of blood will be collected into three
tubes which contain 1 ml of citrate solution each.
Study burden and risks
Venipunctures will be performed by experienced co-workers. Nevertheless, blood
sampling causes local bruising and incidentally a hematoma may occur.
Occasionally, a donor might feel dizzy or can faint during or after the blood
sampling. There is also a small possibility that an infection occurs. All
possible precautions will be taken to avoid manifestation of these risks. There
will be no direct benefit to the subjects.
Oxfordlaan 70
Maastricht 6229EV
NL
Oxfordlaan 70
Maastricht 6229EV
NL
Listed location countries
Age
Inclusion criteria
Healthy men and women between 18 and 65 years
Exclusion criteria
- Use of a drug that interferes with coagulation (e.g. oral anticoagulants, oral contraceptives, oral antiplatelet drugs).
- A history of bleeding or thrombosis
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 | NL42699.068.12 |