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

Completed

• Conditions: ARDS; Pneumonia; Hemostasis; COVID-19; Coagulation

• Registration Number: NCT04366752
• 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 pro-inflammatory 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. Very few data are available regarding the biological disorders of coagulation in these patients. Th purpose of this project is to analyze hemostasis and coagulation of patients with infection of COVID-19 and severe pneumonia.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-22
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-29
• Primary Completion: 2020-08-22
• Study Completion: 2020-09-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• patients hospitalized in medical ICU with pneumonia due to 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 Covid-19 patients with pneumonia admitted in ICU.	up to 6 weeks	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 Covid-19 patients with pneumonia admitted in ICU.	up to 6 weeks	Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.	up to 6 weeks	Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.	up to 6 weeks	Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France