SARS-CoV2 vaccination and activation of the clotting system

SARS-CoV2 vaccination and activation of the coagulation system

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001655-13-NL

Enrollment

Registered

2021-03-24

Start date

2021-04-01

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus disease 2019 and thromboembolism

Interventions

Trade Name: COVID-19 Vaccine AstraZeneca Product Name: COVID-19 Vaccine AstraZeneca Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Main Objective: To explore the change in circulating biomarkers of activation of the coagulation system before and after SARS-CoV2 vaccination (AstraZeneca).;Secondary Objective: To explore the change in inflammatory cytokines before and after SARS-CoV2 vaccination (AstraZeneca).;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: 24 hours and 48 hours after vaccination with COVID-19 Vaccine AstraZeneca	—

Measure

Time frame

Main Objective: To explore the change in circulating biomarkers of activation of the coagulation system before and after SARS-CoV2 vaccination (AstraZeneca).;Secondary Objective: To explore the change in inflammatory cytokines before and after SARS-CoV2 vaccination (AstraZeneca).;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: 24 hours and 48 hours after vaccination with COVID-19 Vaccine AstraZeneca

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary parameters are: - D-dimer and inflammatory cytokines (TNF-alpha and IL-6);Timepoint(s) of evaluation of this end point: 24 hours and 48 hours after vaccination with COVID-19 Vaccine AstraZeneca	—

Countries

Netherlands

Contacts

Public ContactVascular surgery

Radboudumc

Loes.H.Willems@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026