The primary objective is to determine whether APC is elevated in thrombophilia carriers compared to non-carriers. In parallel we will address. Secondary objectives include assessing whether biomarkers related to angiogenic pathways downstream of APC…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Plasma levels of APC and related plasma proteins.
Secondary outcome
Plasma levels of proteins related to angiogenic pathways. The correlation
between the APC plasma levels according to conventional and the novel assay.
Background summary
Heritable thrombophilia likely leads to elevated levels of activated protein C
(APC) through enhanced thrombin formation, but earlier studies are
inconsistent. APC elevation can possibly explain some of the non-coagulation
related phenotypes seen in heritable thrombophilia through APC*s interactions
with various pathways. Pathways that can be influenced by APC include the EPCR
and PAR1 signaling pathway, the Tie2/Angiopoietin system and the
plasminogen/plasmin system. We hypothesize that these pathways might be
involved in creating the favorable phenotypes of thrombophilia mutation
carriers seen in fertility, pregnancy complications, diabetic nephropathy,
sepsis and acute respiratory distress syndrome.
Study objective
The primary objective is to determine whether APC is elevated in thrombophilia
carriers compared to non-carriers. In parallel we will address. Secondary
objectives include assessing whether biomarkers related to angiogenic pathways
downstream of APC are altered in thrombophilia carriers compared to
non-carriers and evaluating a novel APC assay compared to a conventional one.
Study design
Cross-sectional study.
Study burden and risks
Subjects will be undergo a single venipuncture during one visit. The risk and
burden are considered low. Participation has no benefit to the individual
subject.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Population 1: healthy, 18 years or older, thrombophilia carriership (cases).
Population 2: healthy, 18 years or older, pregnant, thrombophilia carriership (cases)
Exclusion criteria
Medication that influences secondary hemostasis, known risk factors for venous thromboembolism, current pregnancy complications.
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 | NL51349.018.14 |