The gaol of the present study is to determine the role of platelet derived TFPI on coagulation in healthy male subjects (n=10) and in healthy female subjects either using ( n=10) or not using oral contraceptives (n=10). Additionally 8 healthy…
ID
Source
Brief title
Condition
- Other condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Coronary artery disorders
Synonym
Health condition
gezonde proefpersonen, fysiologie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the peak height of the thrombin generation curve
in plasma obtained from non activated platelet rich plasma (PRP) compared with
the peak height of the thrombin generation curve in plasma obtained from
activated PRP by T different agonists. Thrombin generation will be determined
under different assay conditions:
triggered with low and hihg TF concentrations
in the absence and presence of anti-TFPI antibodies and anti protein S
antibodies. In 8 healhty volunteers different available TFPI tests will be
performed.
Secondary outcome
TFPI elisa and protein S elisa in plasma obtained from non activated platelet
rich plasma (PRP) compared with the peak height of the thrombin generation
curve in plasma obtained from activated PRP activated by platelet agnostists.
western blot, flow cytometry, activity assays.
Background summary
Tissue factor pathway inhibitor (TFPI) is a natural and potent anticoagulant
protein. It is a kuntiz type serine protease and has a acidic N terminal
region, three tandemly ranked kunitz-domains and a basic C-terminal region. The
protein has a plamsa concentration of 2.5nM en only 10% of plasma TFPI is the
free full length form, which is recognized as the active anticoagulatn form of
the protein. About 5-10% of plasma TFPI is located within platelets. However
the role of platelet TFPI in coagulation is not known.
Study objective
The gaol of the present study is to determine the role of platelet derived TFPI
on coagulation in healthy male subjects (n=10) and in healthy female subjects
either using ( n=10) or not using oral contraceptives (n=10). Additionally 8
healthy volunteers (M/F, age 18-55 years olf) will be included. in total 38
healthy volunteers will be included in the study. Exclusion criteria are the
use of anticoagulant agents or thrombocytaggregation inhibitors/NSAIDs in the
two weeks prior to the study.
Study design
It is a invasive observational study. The burden for the volunteers is low. One
blood sample will be taken on one single occasion. Subjects included in the
study are healthy male and female subjects aged between 18 aan 55 years old.
Subjects will be recruted from the hospital and unversity employees. Written
informed consent will be obtained from all participant before the blood
collection. In total 31.5 mL of blood wil be taken: 4.5mL of EDTA blood for
whole blood count. 18mL citrated blood for activation of platelets by platelet
agnosists, and 9 mL of citrated blood as a control (a buffer will be added as a
control).
Study burden and risks
The risks involved in this study are equal to risk associated with a vein
puncture. These are small hematomas at the site of puncture and bruising and
will dissapear spontaneously over a couple of days. Fainting might results
during blood collection. Therefore samples will be obtained in the supine
position.
universiteitssingel 50
Maastricht 6229ER
NL
universiteitssingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
age 18-55 years old
written informed consent
Exclusion criteria
use of anticoagulant agents (such as heparin, vitamin K antagonists)
use of aspirine, clopidogrel or non steroidal anti-inflammatory drugs within 2 weeks prior to the study
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 | NL38317.068.11 |