The primary objective of this study is: to develop a blood vessel-on-chip model that mimics hypercoagulability in patients with COVID-19. The secondary objective is: to evaluate the efficacy of agents that inhibit COVID-19-related hypercoagulability…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be in situ platelet aggregation and coagulation
measured using the blood-vessel-on-chip technology.
Secondary outcome
Secondary outcomes include changes in gene expression profiles in the chip, and
markers of coagulopathy (e.g. D-dimer) and neutrophil extracellular traps (e.g.
citrullinated histone H3).
Background summary
Intravascular clotting and thrombosis is a major aspect of COVID-19
pathophysiology. Patients that have high plasma values
for fibrinolytic products have a highly increased mortality. Interestingly,
treatment with anti-coagulants seems to improve the
outcome of patients in the intensive care unit. In order to further understand
the underlying mechanisms and to optimize
treatments, there is a need for preclinical model systems that recapitulate
these disease processes of COVID-19. Previous research has shown that
microfluidic *blood vessel-on-chip* models, in which microfluidic channels are
lined with human stem
cell-derived endothelium and perfused with human whole blood, can be used to
study thrombosis and coagulation in an
integrative and well-controlled manner.
Study objective
The primary objective of this study is: to develop a blood vessel-on-chip model
that mimics hypercoagulability in patients with COVID-19.
The secondary objective is: to evaluate the efficacy of agents that inhibit
COVID-19-related hypercoagulability.
Study design
The study design of this project is a prospective observational cohort study.
Study burden and risks
As this is an observatory study subject will have no direct benefits or risk by
participating in the study. The negligible risks of participation are limited
to the complications of vena puncture using phlebotomy. These complications
consist out of hematoma formation, infection, and thrombophlebitis.
Mijbergdreef 9
AMSTERDAN 1105 AZ
NL
Mijbergdreef 9
AMSTERDAN 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1) Age >18 yr or older
2) Suspected SARS-CoV-2 infection
3) Need for oxygen supplementation
4) CRP-level * 50 mg/L
5) D-dimer level *1.0 mg/L
6) Ability to provide written informed consent
Exclusion criteria
1) History of venous thromboembolism
2) Use of anticoagulant therapy at inclusion
3) Known hereditary or acquired thrombophilia
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 | NL75290.018.20 |