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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Unknown status

CT.gov ID

NCT04366752

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

19.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia ARDS Hemostasis Coagulation	Other: venous ultrasound Other: blood sample

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 22, 2020

Anticipated Primary Completion Date :

Aug 22, 2020

Anticipated Study Completion Date :

Sep 22, 2020

Outcome Measures

Primary Outcome Measures

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.