Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy

Recruiting

• Conditions: Coagulation; COVID-19; Hemostasis

• Registration Number: NCT04377490
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components.

Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of proinflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation induced thrombosis.

Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. The purpose of this project is to analyze hemostasis and coagulation of every hospitalized patient with infection of COVID-19.

Blood sample for coagulation and hemostasis analysis will be collected on every patient hospitalized in Amiens hospital for COVID-19 infection. Thrombin time, factors V and II, fibrin/fibrinogen degradation products, antithrombin will be assessed every week. Anticardiolipin, anti-beta2 glycoprotein I and anti-annexin A2 antibodies IgG and IgM at day of admission and at fourth week after admission will be assessed. SARS-CoV2 viral load and serodiagnosis will be performed at the same time. At the same time venous ultrasound to diagnose thrombosis will be performed.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-04
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Primary Completion: 2023-10
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• all patients hospitalized in Amiens Hospital with COVID-19 infection

Exclusion Criteria

• patients< 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation of thrombin time (in secondes) in Hospitalized Covid-19 patients	up to 6 weeks	Variation of thrombin time (in secondes) in Hospitalized Covid-19 patients. The reference range for the thrombin time is usually less than 20 seconds (ie, 15-19 seconds)
Variation of factor V concentration (U/dL) in Hospitalized Covid-19 patients.	up to 6 weeks	Variation of factor V concentration (U/dL) in Hospitalized Covid-19 patients.
Variation of factor II concentration (U/dL) in Hospitalized Covid-19 patients	up to 6 weeks	Variation of factor II concentration (U/dL) in Hospitalized Covid-19 patients
Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Hospitalized Covid-19 patients.	up to 6 weeks	Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Hospitalized Covid-19 patients.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France