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

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ClinicalTrials.gov Identifier: NCT04366752
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
COVID-19 Pneumonia ARDS Hemostasis Coagulation Other: venous ultrasound Other: blood sample

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Study Type : Observational
Estimated 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 : April 22, 2020
Estimated Primary Completion Date : August 22, 2020
Estimated Study Completion Date : September 22, 2020

Resource links provided by the National Library of Medicine



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    blood sample for coagulation and hemostasis analysis will be withdrawn from artery catheter from the day of admission in ICU until the day of patient discharge


Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
blood sample for coagulation and hemostasis analysis


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
every patient hospitalized in CHU Amiens medical ICU with pneumonia due to COVID-19 infection
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients< 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366752


Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: Michel Slama, Pr    (33)3 22 08 78 41    slama.michel@chu-amiens.fr   
Contact: Julien Maizel, Pr    (33)3 22 08 78 07    maizel.julien@chu-amiens.fr   
Sub-Investigator: Clement Brault, MD         
Sub-Investigator: Yoann Zerbib, MD         
Sub-Investigator: Simon Soudet, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04366752    
Other Study ID Numbers: PI2020_843_0036
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
COVID-19
pneumonia
ARDS
venous ultrasound
hemostasis
coagulation
Additional relevant MeSH terms:
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Pneumonia
Thromboembolism
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases