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

NCT04366752 | Completed

• 1 other identifier: PI2020_843_0036
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Pneumonia; ARDS; Hemostasis; Coagulation

Keywords

COVID-19; pneumonia; ARDS; venous ultrasound; hemostasis; coagulation

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Interventions

venous ultrasound OTHER

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 OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

every patient hospitalized in CHU Amiens medical ICU with pneumonia due to COVID-19 infection

You may qualify if:

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

You may not qualify if:

• patients\< 18 years

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample for coagulation and hemostasis analysis

MeSH Terms

Conditions

COVID-19; Pneumonia; Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: April 22, 2020
• Primary Completion: August 22, 2020
• Study Completion: September 22, 2020
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)