SARS-CoV2 vaccination and activation of the coagulation system

Phase 4

Completed

• Conditions: covid-19; thrombosis; 10047438; 10014523

• Registration Number: NL-OMON51038
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-05-31
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the presence of coagulation factor-inhibitor complexes<br /><br>above detection levels in peripheral blood:<br /><br>- TAT (Thrombin Antithrombin complex)<br /><br>- Pka:C1Inhibitor<br /><br>- FXIa:a1AT<br /><br>- FXIa:C1 Inhibitor<br /><br>- FXIa:AT<br /><br>- FIXa:AT<br /><br>- FVIIa:AT</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are:<br /><br>- D-dimer and inflammatory cytokines (TNF-alpha and IL-6)</p><br>