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

COVID-19 Clinical Trial

— THROMBOCOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366752
• Other study ID #: PI2020_843_0036
• Status: Completed
• Start date: April 22, 2020
• Est. completion date: September 22, 2020

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 22, 2020
• Est. primary completion date: August 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients hospitalized in medical ICU with pneumonia due to COVID-19 infection

Exclusion Criteria:

• patients< 18 years

Related Conditions & MeSH terms

• ARDS
• Coagulation
• COVID-19
• Hemostasis
• Pneumonia
• Thromboembolism

Intervention

Other:
• venous ultrasound
Venous ultrasound will be performed on patients once a week, every week from the day of admission in ICU until the day of patient discharge
• blood sample
blood sample for coagulation and hemostasis analysis will be withdrawn from artery catheter from the day of admission in ICU until the day of patient discharge

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of thrombin time (in secondes) in Covid-19 patients with pneumonia admitted in ICU.	The reference range for the thrombin time is usually less than 20 seconds (ie, 15-19 seconds)	up to 6 weeks
Primary	Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.	Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.	up to 6 weeks
Primary	Variation of factor II 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
Primary	Variation of concentration of fibrin and fibrinogen degradation products (= 10 µgm/mL) 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