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Completed

NCT Number: NCT04366752

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

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.

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Key information

Conditions

COVID-19 ARDS Cardiovascular Diseases Coagulation Coronaviridae Infections Coronavirus Infections Embolism and Thrombosis Hemostasis Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thrombosis Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80480, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients< 18 years

Treatment and study plan

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blood sample for coagulation and hemostasis analysis will be withdrawn from artery catheter from the day of admission in ICU until the day of patient discharge

Primary outcomes

  1. Variation of thrombin time (in secondes) in Covid-19 patients with pneumonia admitted in ICU.

    Time frame: up to 6 weeks

    The reference range for the thrombin time is usually less than 20 seconds (ie, 15-19 seconds)

  2. Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.

    Time frame: up to 6 weeks

    Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.

  3. Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.

    Time frame: up to 6 weeks

    Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.

  4. Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: THROMBOCOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2020
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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