To explore the change in circulating biomarkers of activation of the coagulation system before and after SARS-CoV2 vaccination (AstraZeneca).
ID
Source
Brief title
Condition
- Viral infectious disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the presence of coagulation factor-inhibitor complexes
above detection levels in peripheral blood:
- TAT (Thrombin Antithrombin complex)
- Pka:C1Inhibitor
- FXIa:a1AT
- FXIa:C1 Inhibitor
- FXIa:AT
- FIXa:AT
- FVIIa:AT
Secondary outcome
Secondary parameters are:
- D-dimer and inflammatory cytokines (TNF-alpha and IL-6)
Background summary
It has been well established that increased D-dimer levels correlate with poor
outcome after COVID-19 and thrombotic complications are frequent complications
in patients during the acute and recovery phase of COVID-19 disease. Markers of
coagulation activation are increased during Covid-19 dependent on severity.
Unpublished data from our group show that ~3 months after COVID-19 infection
the same complexes of coagulation factors and their inhibitors in circulating
blood are still increased in 40-50% of all patients (paper in preparation).
Recently, the vaccination program with SARS-CoV2 (AstraZeneca) was discontinued
in several European countries including the Netherlands because of a possible
relationship with some severe cases of thrombosis combined with thrombopenia.
The question arises whether SARS-CoV2 vaccination can induce activation of the
coagulation system. To explore this question we propose an explorative,
observational cohort study in patients undergoing SARS-Cov2 vaccination
(AstraZeneca) in Groesbeek once the nationwide vaccination program continues in
the Netherlands (planned March 28th).
Study objective
To explore the change in circulating biomarkers of activation of the
coagulation system before and after SARS-CoV2 vaccination (AstraZeneca).
Study design
An explorative, observational cohort study including patients undergoing
SARS-CoV2 vaccination (AstraZeneca). The COCOS study is initiated by and will
be conducted by the Radboudumc. Participants are recruited from the general
practice Paulus Potter (Groesbeek, the Netherlands).
Study burden and risks
Patients will be invited for venous blood sampling just before vaccination and
24-48 hours after vaccination at Pharmacy Groesbeek. Venous blood sampling kan
cause a temporary uncomfortable sensation and/or bruising.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- adult patients (age > 18 years)
- obtained written informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- patients with Down syndrome
- patients with known coagulation disorders
- patients on anticoagulants (vitamin K antagonist, low-molecular weight
heparin or direct oral anticoagulants)
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2021-001655-13-NL |
| CCMO | NL77323.091.21 |