Primary objective: Compare characteristics of endothelium from older individuals with or without previous unprovoked VTE.Secondary objectives: 1) Determine the blood plasma proteome between the different groups and 2) to evaluate the prothrombotic…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Vascular injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-difference in expression of senescence markers in endothelial colony forming
cells (ECFCs) from older individuals with versus without a previous unprovoked
VTE.
Secondary outcome
-difference in abundance of 270 plasma proteins as measured with quantitative
mass spectrometry between older individuals with or without a previous VTE
-difference in thrombin generation capacity of endothelial colony forming cells
(ECFCs) from older individuals with or without previous VTE in an organ on a
chip model for thrombosis.
Background summary
Older individuals have an increased risk of venous thromboembolism (VTE), which
could be explained by the accumulation of risk factors and comorbidities that
increase with aging. Nevertheless, these risk factors cannot fully explain the
mechanisms enhancing VTE risk in older individuals. The expression of p53 in
endothelial cells appears to have an essential role in VTE onset in aged mice,
as the deletion of p53 completely prevented thrombus formation. Aged mice
expressing p53 showed increased plasma levels of the coagulation factor Xa, and
p53 inhibition reduced levels of the initiator of blood coagulation, tissue
factor, on cultured umbilical vein endothelial cells. Nevertheless, these
events have not been studied in a humanized setting. We hypothesize that
increased senescence leads to a more pro-coagulant state in older patients.
Study objective
Primary objective: Compare characteristics of endothelium from older
individuals with or without previous unprovoked VTE.
Secondary objectives: 1) Determine the blood plasma proteome between the
different groups and 2) to evaluate the prothrombotic nature of endothelium
from older individuals (with or without previous unprovoked VTE).
Study design
The study is a case-control study where patients with VTE are compared with
patients without, using basic science, experimental in vitro techniques that
require the sampling of venous peripheral blood of the participants.
Study burden and risks
The objectives of this study can only be reached by studying individuals with
VTE and healthy controls. As only 70 ml of blood will be drawn from all
participants at one single time point, the burden is low and no AEs, SAEs or
SUSARs are expected. While the participants will not directly benefit from the
study, the outcomes may lead to better understanding and ultimately prevention
of VTE in older people in the future.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
-patients/volunteers older than 60 years
-diagnosis of VTE 1 year or longer before blood draw
Exclusion criteria
-active cancer
-symptomatic vascular disease, as defined by the use of platelet aggregation
inhibitors
-severe renal insufficiency (eGFR<30),
-diabetes
Design
Recruitment
metc-ldd@lumc.nl
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 | NL83960.058.23 |